tag:blogger.com,1999:blog-51626842198651622182024-03-06T13:00:08.487-07:00Onco'Zine - The International Cancer BlogOnco’Zine reports about current research and development in hematology and oncology and includes comments on peer-reviewed reports and congress reports from international medical meetings.Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.comBlogger147125tag:blogger.com,1999:blog-5162684219865162218.post-38049422822046911332010-12-23T12:31:00.001-07:002010-12-31T13:53:21.057-07:00Approval of Nilotinib Gives Patients With Newly Diagnosed Ph+ Chronic Myeloid Leukemia New Medical Option<p><strong><em>The European Commission has approved nilotinib (Tasigna®, Novartis) as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.</em></strong><br />
<br />
Nilotinib is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia (CML) in the chronic phase. The new agent has also been approved in over 90 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including imatinib (Glivec®; known as Gleevec® in the USA, Canada and Israel)[8]. The effectiveness of nilotinib for this indication is based on confirmed hematologic and unconfirmed cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. <br />
<br />
The approval from the European Commission followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). It is based on findings from a pivotal Phase III trial demonstrating superiority to the standard of care imatinib in achieving molecular and cytogenetic response and delaying cancer progression. These data were first published in the June 17 issue of The New England Journal of Medicine [1] and were confirmed by 18-month median follow-up data presented at the 46th American Society of Clinical Oncology (ASCO) annual meeting held in June 2010 [2].<br />
<br />
The US Food and Drug Administration (FDA), Swissmedic and Japan's Ministry of Health, Labour and Welfare have also approved nilotinib in this first-line indication. Regulatory submissions are under review in other countries worldwide.<br />
<br />
"We are pleased that Tasigna is now approved for newly diagnosed Ph+ CML patients in chronic phase in the member states of the European Union," said Hervé Hoppenot, President, Novartis Oncology. "With this expanded indication, newly diagnosed patients can benefit from a Bcr-Abl tyrosine kinase inhibitor that, according to pivotal data, surpassed the standard of care Glivec, in key measures of efficacy, including delaying disease progression at 12 months."<br />
<br />
In laboratory studies, nilotinib has been shown to be a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML,[3]. It has also been shown to be active against a broad spectrum of Bcr-Abl mutations associated with resistance to imatinib [4]. <br />
<br />
In its pivotal head-to-head trial, nilotinib surpassed imatinib in key measures of treatment efficacy, as has been reported. nilotinib eliminated Bcr-Abl faster and more deeply than imatinib and resulted in lower rates of cancer progression after 12 months of therapy[1]. Major molecular response (MMR), a measure of deep reduction in Bcr-Abl, is considered to be a critical therapeutic milestone associated with good long-term outcomes for patients with Ph+ CML in chronic phase[5]-[7]. Treatment with nilotinib led to higher rates of both MMR and complete cytogenetic response (CCyR) (undetectable levels of the Philadelphia chromosome that is the hallmark of this cancer) compared with imatinib [1].<br />
<br />
After a median of 18 months of follow-up treatment, two patients on the nilotinib 300 mg twice daily arm progressed to either accelerated phase or blast crisis while 17 patients on the imatinib arm progressed to either accelerated phase or blast crisis. In the study, nilotinib and imatinib were generally well tolerated. Fewer patients discontinued due to adverse events from the nilotinib 300 mg twice daily arm of the study compared to the imatinib 400 mg once daily arm.<br />
<br />
The randomized, open-label, multicenter trial, called ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients), compared the efficacy and safety of nilotinib versus imatinib in adult patients with newly diagnosed Ph+ CML in chronic phase[1]. It is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients in chronic phase.<br />
<br />
This year, Novartis also began collaboration with molecular diagnostics company Cepheid to develop a new FDA cleared/approved Bcr-Abl test, which adheres to the International Scale. The goal of the collaboration is to help doctors more reliably monitor Ph+ CML patients. Cepheid and Novartis also will develop a next generation test, which is expected to enable even more sensitive testing, indicating the depth of a patient's response to tyrosine kinase inhibitors, including nilotinib and imatinib. Currently, there are no FDA cleared/approved tests to monitor for Bcr-Abl.<br />
<br />
Earlier this month nilotinib was also approved by Japan's Ministry of Health, Labour and Welfare to offer as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. <br />
<br />
<strong>References:</strong><br />
[1] Saglio G, Kim D-W, Surapol Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2251-9.<br />
[2] Larson R, Philipp le Coutre, Reiffers J, Hughes T. et al. Nilotinib is Superior to Imatinib in Patients (pts) with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTnd Beyond One Year. Abstract # CRA6501. American Society of Clinical Oncology 2010 Annual Meeting <br />
[3] le Coutre P, Ottmann OG, Giles F, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or-intolerant accelerated-phase chronic myelogenous leukemia. Blood. 2008 Feb 15;111(4):1834-9.<br />
[4] Swords R, Mahalingam D, Padmanabhan S, et al. Nilotinib: optimal therapy for patients with chronic myeloid leukemia and resistance or intolerance to imatinib. Drug Des Devel Ther. 2009 Sep 21;3:89-101<br />
[5] Hochhaus A, O'Brien SG, Guilhot F,et al. IRIS Investigators. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61.<br />
[6] Müller MC, Hanfstein B, Erben P, et al. Molecular response to first line imatinib therapy is predictive for long term event free survival in patients with chronic phase chronic myelogenous leukemia - an interim analysis of the randomized German CML Study IV. Blood (ASH Annual Meeting Abstracts) 2008, 112: Abstract 333.<br />
[7] Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol. 2009 Dec 10;27(35):6041-51.<br />
[8] Glivec® (imatinib) prescribing information. Basel, Switzerland: Novartis International AG; March 2009<br />
<br />
<strong>For more information:</strong><br />
[9] <a target="_blank" href="http://api.ning.com:80/files/u91-PTBT8YnJC39NIglP6p-sbHDABHwMt34AozlZ2XFwm1KWnWU2ifvUMEXNrRpJ0V-a06dO2tx9UR3ojbChpILVStYN17qF/N_T_SPC_WC500034394.pdf">Summary of Product Characteristics</a> (Nilotinib, Tasigna®)<br />
[10] <a target="_blank" href="http://api.ning.com:80/files/zr-aN9MDXULl9DRyCJS9Y3j-noXdsxRbJqEo9MZOB47nwa0Hfy6a9cZNRzS2dv7VvhshAMKu3ADTdy8CNmy5XWXpLjr6Qsz5/N_T_1_WC500034396.pdf">EPAR Summary for the Public</a>.</p><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-11160787845739187492010-12-01T12:51:00.004-07:002010-12-05T12:56:22.874-07:00News Study Shows: Annual Breast Cancer Screening Beginning at Age 40 Reduces Mastectomy Risk<STRONG><EM>Having a yearly mammogram greatly reduces the risk of mastectomy following breast cancer in women between the ages of 40 and 50, according to a study being presented today at the annual meeting of the Radiological Society of North America (November 28 - December 3, 2010, McCormick Place, Chicago).<BR></EM></STRONG><BR>"The results of this study support the importance of regular screening in the 40 to 50 age group," said lead author Nicholas M. Perry, M.B.B.S., F.R.C.S., F.R.C.R., director of The London Breast Institute at The Princess Grace Hospital in London. "Women in this age group who had undergone mammography the previous year had a mastectomy rate of less than half that of the others."<BR><BR>An estimated 207,090 new cases of invasive breast cancer will be diagnosed in American women in 2010. Currently, the American Cancer Society recommends annual mammography screening for women beginning at age 40 in the U.S., but last year, the <A href="http://www.ahrq.gov/clinic/uspstfix.htm" target=_blank>U.S. Preventive Services Task Force</A> recommended changing the guidelines to begin screening biennially (every other year) at age 50. There are no routine screening guidelines for women under 50 in the U.K. <BR><BR>The researchers studied the benefits of screening women between the ages of 40 and 50, the frequency of mammography and the type of treatment after breast cancer diagnosis.<BR><BR>Dr. Perry and colleagues reviewed the clinical data available on women from 40 to 50 that had been diagnosed with breast cancer and treated at The London Breast Institute. Between 2003 and 2009, 971 women had been diagnosed with breast cancer. At the time of diagnosis, 393 (40%) of the women were under 50, with 156 of these women completing treatment at the center. Of the treated women, 114 (73%) had no prior mammograms. Forty-two women had been previously screened with mammography, of whom 29 had at least one mammogram within the previous two years. Of those, 16 women had a mammogram one year prior. <BR><BR>"We reviewed the records of the women needing mastectomy to determine whether or not they had undergone mammography the previous year," Dr. Perry said. "We were surprised at the degree of benefit obtained from yearly screening in this age group."<BR><BR>Data showed that mastectomy was the required treatment for 3 (19%) of the 16 women who had been screened the prior year, compared to 64 (46%) of the 140 women who had not been screened in the past year.<BR><BR>"Regular screening is already proven to lower the chance of women dying from breast cancer," Dr. Perry said. "The results of our study support the importance of regular screening in the under-50 age group and confirm that annual mammography improves the chances of breast conservation should breast cancer develop."<BR><BR>Dr. Perry's coauthors for this article are Sue Milner, B.Sc., D.C.R., Kefah Mokbel, M.B.B.S., M.S., F.R.C.S., Stephen W. Duffy, B.Sc., M.Sc., and Katja Pinker, M.D.<BR><BR><STRONG>For more information</STRONG><BR>Prior Mammography in Women Aged 40-50 at a UK Center in Accordance with ACS Guidelines Lowers Mastectomy Rate Following Breast Cancer (<A href="http://rsna2010.rsna.org/program/event_display.cfm?em_id=9012348" target=_blank>Abstract</A>)<BR><BR>This article was first published online at <a href="http://oncozine.ning.com" target="_blank">Onco'Zine - The International Cancer Network</a><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-69285227031005266722010-11-25T13:04:00.002-07:002010-12-05T13:10:16.896-07:00Personalized Cancer Therapy Requires New Strategies for Cancer Drug Development<strong><em>Millions of cancer patients worldwide may soon be able to receive more effective, personalized treatments for their disease thanks to developments in the understanding of cancer biology, experts will say at the</EM> Cancer Biology for Clinicians Symposium <em>organized by the European Society for Medical Oncology (ESMO) in Nice, France on 26-27 November.</EM></STRONG><br />
<br />
To make the most of this coming transformation, governments, pharmaceutical companies and doctors urgently need to adapt the way drugs are developed, the experts say.<br />
<br />
"Cancer therapy is arguably at the most exciting time in its history," said José Baselga, from MGH Cancer Center in Boston, USA, co-chair of the symposium and ESMO Past-President. "It is at the confluence of two new movements, one toward personalized medicine and the other toward the use of new molecularly targeted cancer therapeutics that exploit the tumor's genetic and molecular signature. These movements provide many challenges, but also the opportunity for making paradigm shifts in the way we think of and treat cancer."<br />
<br />
Personalized treatment has become increasingly available for cancers over the past decade. This has partly come about as scientists have found that common tumors such as breast cancer are in fact a mixture of several disease types with distinct molecular features. Meanwhile, molecular targeted drugs have also been developed that inhibit particular molecular targets involved in some cancers.<br />
<br />
"As our understanding of cancer biology develops further, these kinds of personalized treatments are expected to become available for many more cancer types," said Fabrice André, from Institut Gustave Roussy, France, ESMO spokesperson co-chairing a session at the symposium. "If we want to facilitate the implementation of this kind of personalized medicine, then we urgently need to develop new strategies for cancer drug development."<br />
<br />
In particular, it is time to rethink whether the standard model of testing drugs in large phase-III trials is an effective way to bring these targeted cancer drugs to patients, Dr André noted. <br />
<br />
"Regulatory processes are becoming increasingly restrictive in providing patient access to potentially innovative new drugs, because even the largest cancer trials generally involve only a small portion of the cancer patient population, and because the drug development process is often more than a decade from the first preclinical study," he added.<br />
<br />
This is related to the fact that drug approval usually needs large confirmatory trials that are being done in an unselected population. There is a need for smaller trials done with selected patients to be highly sensitive, a concept that requires the development of molecular selection and relative platforms for doing that.<br />
<br />
"It’s clear that we urgently need a new paradigm for drug development, including targeted patient selection for clinical trials, shorter duration of clinical trials and improvement of the cost effectiveness of bringing a new drug to the market."<br />
<br />
The ESMO Cancer Biology for Clinicians Symposium, a two-day meeting featuring some of the most eminent researchers in the field, is designed to inform oncologists about the ways cancer biology is changing clinical practice. <br />
<br />
"What is most exciting today is the active dialogue between clinicians and laboratory scientists who share an interest in applying the new knowledge of cancer biology to the diagnosis, treatment, and prevention of the disease," said meeting co-chair Mario Dicato, from Centre Hospitalier de Luxembourg. <br />
<br />
"In the near future, cancer treatment decisions will be based on biology," said the third meeting co-chair Jean-Charles Soria, ESMO spokesperson from Institut Gustave Roussy, France. "It is therefore vital that medical oncologists have the skills and the knowledge to bring these advances to their patients. The future of oncology will be personalized medicine, and the community needs to discuss how this will be implemented."<br />
<br />
The European Society for Medical Oncology (<a href="http://www.esmo.org" target=_blank>ESMO</A>) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care. The organization is a powerful alliance of more than 6,000 committed oncology professionals from over 100 countries.<br />
<br />
<strong>For more information:</STRONG><br />
Cancer Biology for Clinicians Symposium <a href="http://api.ning.com/files/4s5EbMpRDB0F0cFnNuyy0q8M6mf2vIW2yVtVVEVN7WRv1xjUTPx3YviNw7NhqO37jjNnqy2yGWo3QuSwzRLkzs6NBrNJ3PAA/program_cancerbio.pdf" target=_blank>Program Book</A><br />
<br />
This article was first published online at <a href="http://www.oncozine.ning.com" target="_blank">Onco'Zine - The International Cancer Network</a><br />
<br />
<font size=2>Copyright © 2010 Sunvalley Communication. All rights reserved.<br />
Republication or redistribution of Sunvalley Communication content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Onco'Zine and Oncozine are registered trademarks and trademarks of Sunvalley Communication around the world.</FONT><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-40330508877655434222010-10-25T12:59:00.001-07:002010-12-05T13:02:13.600-07:00Caution Regarding Use Of Erythropoiesis-Stimulating Agents In Cancer Patients Recommended In New Guideline<STRONG><EM>An updated joint guideline by the American Society of Hematology (ASH), the world’s largest professional society concerned with the causes and treatment of blood disorders, and the American Society of Clinical Oncology (ASCO) advises physicians about the appropriate use of erythropoiesis-stimulating agents (ESAs), a class of drugs that stimulate the bone marrow to produce more red blood cells, to treat cancer patients with chemotherapy-induced anemia.</EM></STRONG> <BR><BR>While the guideline cautions that ESAs are associated with shorter survival and increased risk of thromboembolism — blood clots — tumor progression and stroke, it also recognizes their major benefit of reducing the need for red blood cell transfusions, which can potentially cause serious infections and adverse reactions in the immune system.<BR><BR>“This updated guideline offers clinicians the latest synthesis of the medical evidence surrounding use of ESAs in patients with cancer, including appropriate cautions where evidence is lacking or where risks may outweigh the use of ESAs,” said J. Douglas Rizzo, MD, MS, Co-Chair of the guideline panel and Professor of Medicine at the Medical College of Wisconsin.<BR><BR>Those risks may include thromboembolism or even death, according to new data cited in the guideline, which suggests that physicians avoid the use of ESAs in cancer patients who are not receiving chemotherapy, except for those with myelodysplastic syndrome (MDS). At the same time, the guideline confirms the effectiveness of ESAs in sparing patients the need for transfusions, which can substantially impact Quality of Life. By recommending that physicians discuss individual risks and benefits of ESAs and blood transfusion with patients prior to therapy, the guideline recognizes the critical role of shared decision-making between the patient and the physician. <BR><BR>In addition to outlining the clotting risks of ESAs, the guideline makes specific recommendations on usage and provides insights into disease progression and patient survival. The guideline also details new thresholds for initiation and modification of ESAs, which are consistent with current US FDA labeling.<BR><BR>Originally published in 2002 and last updated in 2007, the guideline was derived from analysis of individual patient data, various medical literature, and systematic reviews of published clinical trials. In developing the update, panel members considered all relevant literature published between January 2007 and January 2010. Additional evidence was considered when it was considered pertinent to each section of the updated guideline. <BR><BR>“These guidelines touch on almost all aspects of the use of ESAs in patients with cancer and MDS, as well as secondary issues, such as the role of iron supplementation,” said Samuel Silver, MD, a member of ASH’s Committee on Practice and Professor of Internal Medicine at the University of Michigan. “These are issues that confront practicing hematologists and oncologists on a daily basis, and we hope that these evidence-based recommendations will influence practice standards and result in better care for patients.” <BR><BR><STRONG>For more information:</STRONG><BR>Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, Bennett CL, Bohlius J, Evanchuk D, Goode MJ, Jakubowski AA, Regan DH, Somerfield MR. American Society of Clinical Oncology/American Society of Hematology <A href="http://jco.ascopubs.org/content/28/33/4996.full" target=_blank>Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin in Adult Patients With Cancer</A>J Clin Oncol. 2010 Nov 20;28(33):4996-5010. Epub 2010 Oct 25.<BR><BR>This article was first published online at <a href="http://oncozine.ning.com" target="_blank">Onco'Zine - The International Cancer Network</a><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-43974763225282099482010-10-12T08:33:00.000-07:002010-10-12T08:33:21.253-07:00Original Research, Better Insight And Practice-changing Studies Attract Record Number Of Oncologists To Attend ESMO 2010<b><i>“The 35th ESMO Congress is milestone in our Society’s history. It has been, not only our biggest, but also our best congress ever,” declared ESMO President David J. Kerr at the event’s closing conference today. 16,000 delegates attended the European Society for Medical Oncology (ESMO) congress in Milan this week, including over 13,000 medical oncologists, 380 members of the press and close to 400 patients who participated in a dedicated seminar.</i></b> <br />
<br />
“We believe this success is due to the excellent program that the ESMO Scientific Committee put together this year, including a large amount of original research,” said Prof Kerr.<br />
<br />
Prof Fortunato Ciardiello highlighted as one of the most important clinical studies reported here the results of a large randomized Phase-III trial in prostate cancer patients who had previously failed hormone and chemotherapy. The study was presented by researcher Johann de Bono. “These findings will change daily practice in the treatment of prostate cancer, in particular because they offer a novel and well-tolerated hormone therapy to patients for which no other treatment options were available. They contribute to a new era in drugs for prostate cancer,” said Prof Ciardiello.<br />
<br />
Other practice-changing trials presented at the 35th ESMO Congress include a Chinese study that brings new hope to lung cancer patients (OPTIMAL trial). Lung cancer is the most common and deadliest cancer, but advances presented by Prof Caicun Zhou tripled the time people lived without the disease getting worse. An encouraging trial for ovarian cancer patients (ICON 7) presented by DrTim Perren from the UK, also attracted a lot of attention. In the field of advanced breast cancer, an American study (TDM4450g) that presented a new type of medicine with much lower toxicity compared to the older 'standard' drew a lot of interest. Principal investigator, Dr Edith Perez said the compound had shown to be effective in patients whose metastatic breast cancer had not responded to other treatments.<br />
<br />
Prof Kerr said that what has become clear “is that we need to get back to our laboratories to understand more about the disease. We need more biology and a better insight so that we can treat the right patient, at the right time, with the right drug at the right dose.<br />
<br />
<b>More Information:</b><br />
Visit <a href="http://oncozine.ning.com">Onco'Zine The International Cancer Network</a> for an overview of the daily news from ESMO 2010 conference.<div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-31418153522511864202010-10-08T14:15:00.002-07:002010-10-10T17:44:37.105-07:00Onco'Zine on Ning, Facebook and TwitterPlease note that Onco'Zine is now also available online as a <a href="http://oncozine.ning.com/" target="_blank">'Social Media' type publication </a>. Onco'Zine is also available on Facebook. <br><br>For an overview of articles/RSS on Twitter, please <a href="http://twitter.com/statuses/user_timeline/71468093.rss" target="_blank">click</a> here<div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-8821243626083604182010-03-17T08:00:00.002-07:002010-09-03T22:07:35.708-07:00Dutch Diagnostic Company to Play Pivotal Role in ISPY-2 Trial for Breast Cancer<strong><em>Agendia, a Netherlands genomics cancer diagnostics company and a world leader in molecular cancer diagnostics focused on the personalized treatment of breach cancer patients, will play a major role in the I-SPY 2 TRIAL for breast cancer. The trial is set to launch at the first of nearly twenty research sites.</em></strong><br />
<br />
<br />
I-SPY 2 is an exciting and groundbreaking new clinical trial model that will help scientists quickly and efficiently test the most promising drugs in development for women with higher risk, rapidly growing breast cancers-women for whom an improvement over standard treatment could dramatically change the odds of survival. I-SPY is an initiative of The Biomarkers Consortium, a unique public-private partnership that includes the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH).<br />
<br />
"Cancer tumor profiling in the neoadjuvant setting is critical to the success of the I-SPY 2 trial. Agendia is uniquely positioned to be a part of the Biomarker Consortium in this landmark study, and proud to be working side by side with a large number of visionary therapeutic companies and research centers," said Bernhard Sixt, Chief Executive Officer of Agendia. "Agendia's MammaPrint has proven value for breast cancer recurrence in the neoadjuvant and adjuvant settings, Agendia's TargetPrint provides objective, quantitative information about the expression of ER, PR and Her-2neu, while our DiscoverPrint measures the expression of the whole genome. In concert they will form an integral part of the clinically relevant discoveries the Consortium aims to make."<br />
<br />
MammaPrint, the first and only highly accurate breast cancer recurrence test cleared by the U.S. Food and Drug Administration under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines, identifies patients with early metastasis risk - patients who are likely to develop metastases within five years following surgery. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test results provide doctors with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests. <br />
<br />
Scientists from the National Cancer Institute (NCI), FDA, and nearly 20 major cancer research centers across the United States have united to develop and conduct this unprecedented large-scale scientific collaboration to test novel breast cancer drugs in the neoadjuvant clinical trial setting. Results will be made broadly available to the cancer research and development community in order to foster this integrated approach to improve clinical trial success and the efficacy of cancer therapeutics.<div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-72338199181875511802010-03-04T16:00:00.001-07:002010-09-03T21:56:29.405-07:00European Breast Cancer Patients to be Treated With Revolutionary Therapy System<strong><em>For the first time, breast cancer patients in Europe will receive treatment using a revolutionary system called AccuBoost. The Italian hospital where the patients are being treated is using the technology to pinpoint the tumor bed and treat it whilst still protecting the patient's healthy surrounding tissue and organs.</em></strong><br />
<br />
<br />
The new treatment option is made possible by the system combining real-time mammographic image guidance and non-invasive use of a radiotherapy technique called brachytherapy, a high-precision radiation therapy in which the radiation source used to kill cancer cells and shrink tumors is placed in or close to the tumor itself. Precision brachytherapy allows a physician to concentrate a high dose of radiation in a small area, minimizing damage to nearby, healthy body tissue and organs, over a shorter treatment period.<br />
<br />
Professor Roberto Orecchia; Director of the Division of Radiotherapy, is leading the use of the new system at the Istituto Europeo di Oncologia in Milan and explained: 'When the patient is treated with AccuBoost, the image is seen in real-time, guaranteeing radiotherapy that is extremely precise in its targeting of the tumour bed. This is a very innovative procedure because for the first time mammography images can be used to guide the radiotherapy treatment in such an extremely precise and adaptive manner. There is also a time benefit, so this year, we will be able to treat 50 percent of patients more quickly and efficiently than before, reducing treatment time from six weeks to three weeks.'<br />
<br />
The Istituto Europeo di Oncologia is the first hospital in Europe to use AccuBoost, which was certified for use in Europe just six weeks ago. The technology was developed by Nucletron, a knowledge-based leader in Radiation Oncology, and ART a company dedicated to the advancement of partial breast irradiation with the goal of reducing the cancer recurrence rate and minimizing radiation related complications. The two companies specialize in advancing radiation oncology by developing state-of-the-art equipment for high precision brachytherapy.<div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-68846945547633209782010-03-03T16:46:00.007-07:002010-09-03T21:50:37.114-07:00Updated IMPACT Results Confirm that Provenge® Improves Overall Survival in Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC)<strong><em>Data from the pivotal Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study, a 512-patient, multi-center, randomized, double-blind, placebo-controlled study evaluating men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC) with overall survival as the primary endpoint, demonstrates that sipuleucel-T (Provenge®, Dendreon Corporation) does extends overall survival in men with CRPC. The data will be presented at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco on Friday, March 5 at 1:45 pm PT.</em></strong><br />
<br />
<em>Active Cellular Immunotherapies</em><br />
<br />
Sipuleucel-T is an investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of Active Cellular Immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. The drug candidate and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In contrast to Passive Cellular Immunotherapy, where effector cells are infused into the patient but not induced or expanded within the patient, ACI involves inducing an effective response to tumor cells within patients whose immune systems have failed to do so on their own. These methods generally involve introducing tumor antigens to the host effector cells.<br />
<br />
<em>Results</em><br />
<br />
A sensitivity analysis performed with longer-term follow-up (36.5 months) and additional events (349 deaths) collected at the time of study closure demonstrated that sipuleucel-T increased three-year survival by 40 percent compared to placebo (32.1% vs 23.0%), the median survival difference of sipuleucel-T compared to placebo was maintained at 4.1 months, with a 24.1% reduction in the risk of death [HR=0.759] and a p-value of 0.017.<br />
<br />
As previously reported in a primary analysis (34.1 months median follow-up; 331 deaths), the IMPACT study met its pre-specified primary endpoint of significantly improving overall survival compared to placebo, demonstrating that sipuleucel-T increased three-year survival by 38 percent compared to placebo (31.7% vs 23.0%), extending median survival by 4.1 months compared to placebo (25.8 months vs. 21.7 months), with a 22.5 percent reduction in the risk of death [HR=0.775] and a p-value of 0.032.<br />
<br />
In addition, new analyses demonstrated that the median predicted survival of the two treatment arms using the Halabi model were well balanced (20.3 months for sipuleucel-T vs 21.2 months for placebo). Furthermore, in an analysis in which patients were censored at the time of docetaxel use, the sipuleucel-T treatment effect remained strong [HR=0.649].<br />
<br />
As previously reported, the most common adverse reactions were chills, fever, headache, aches, influenza-like illness and sweating.<br />
<br />
"The results from the IMPACT study corroborate earlier studies with sipuleucel-T in demonstrating an improvement in overall survival for men with metastatic castration resistant prostate cancer. This is the first therapeutic vaccine to demonstrate a survival benefit in cancer," said Philip Kantoff, M.D., Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and principal investigator of the IMPACT study. "Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile."<br />
<br />
<em>License Application</em><br />
<br />
Dendreon Corporation is seeking licensure for sipuleucel-T for men with metastatic CRPC and submitted an amended Biologics License Application for which the U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act date of May 1, 2010.<div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-25957499247814432452010-01-30T17:19:00.001-07:002010-01-30T17:22:26.673-07:00First Targeted Biological Therapy to Show Survival Benefit in Stomach Cancer<span style="font-size: large;"><i><b>The European Commission has approved trastuzumab (herceptin, Roche Pharmaceuticals) in combination with chemotherapy for use in patients with HER2-positive metastatic stomach (gastric) cancer.</b></i></span> <br />
<br />
Trastuzumab is a humanized antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of trastuzumab is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumor. trastuzumab has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer.<br />
<br />
The approval of trastuzumab in combination with chemotherapy for the treatment of metastatic stomic cancer is based on the impressive results from the international ToGA trial, which showed that treatment with trastuzumab significantly prolongs the lives of patients with this aggressive cancer. Overall survival for patients with high levels of HER2 in the ToGA study was 16 months versus 11.8 months (on average) for patients receiving chemotherapy alone [1]<br />
<br />
“Herceptin is the first targeted biological therapy to show a survival benefit in advanced stomach cancer and represents a significant advance in the treatment of this devastating disease”, said Pascal Soriot, Chief Operating Officer of, Roche’s Pharmaceutical Division. “We believe that Herceptin will help patients with HER2-positive stomach cancer, as much as it has helped so many women with HER2-positive breast cancer.”<br />
<br />
Based on the strong results from the phase III ToGA study, the submission for the label extension was reviewed in an accelerated process by the European Health Authorities, allowing patients to benefit sooner from this life-extending treatment. This marketing authorization is valid with immediate effect in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway). Following approval in the European Union, approvals for a label extension for trastuzumab in other regions of the world are expected to follow soon.<br />
<br />
“I am delighted that today’s approval will make Herceptin available to patients with HER-2 positive metastatic stomach cancer across Europe,” said Professor Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium, one of the lead investigators of the ToGA trial. “The approval of Herceptin for HER2-positive stomach cancer represents an important advance for the treatment of these patients. Clinicians will need to ensure that patients with metastatic stomach cancer are accurately tested for HER2 expression.”<br />
<br />
<b>Diagnosis and treatment</b><br />
Stomach cancer is the second most common cause of cancer-related death in the world and is the fourth most commonly diagnosed cancer, with over 1,000,000 cases of stomach cancer diagnosed each year [2] Advanced stomach cancer is associated with a poor prognosis; the median survival time after diagnosis is approximately 10-11 months with currently available therapies. [3] Approximately 15 - 18% of stomach tumours show high levels of HER2 [4,5]. Early diagnosis of this disease is challenging because most patients do not show symptoms in the early stage.<br />
<br />
ToGA is the first randomized Phase III trial investigating the use of trastuzumab in patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive stomach cancer. Approximately 3,800 patients were tested for HER2-positive tumors and 594 patients with HER2-positive disease were enrolled into the study. The rationale for conducting this trial was based on the knowledge that the targeted therapy trastuzumab has demonstrated unprecedented efficacy in the treatment of HER2-positive breast cancer. In addition, the overexpression of HER2 was also observed in stomach cancer. Targeted cancer therapies are drugs or other substances that block the growth and spread of cancer by interfering with specific molecules involved in tumor growth and progression.<br />
<br />
In the ToGA study, patients were randomized to receive one of the following regimens as their first line of treatment:<br />
<br />
<ul><li>A fluoropyrimidine (capecitabine (xeloda) or intravenous 5-FU (5-fluorouracil)) and cisplatin every 3 weeks for 6 cycles. Most patients were receiving capecitabine and cisplatin as chemotherapy</li>
<li>Trastuzumab 6mg/kg every 3 weeks until progression in combination with a fluoropyrimidine and cisplatin for 6 cycles</li>
</ul><b>Study results</b><br />
The primary objective of the study was to demonstrate superiority in overall survival of the trastuzumab containing treatment arm compared to the chemotherapy alone arm. The pre-planned interim analysis was triggered by the occurrence of 347 events. Secondary endpoints for the study included progression-free survival, overall response rate, duration of response, safety and quality of life. In the ToGA study, no new or unexpected side effects were observed. For overall survival, the Hazard Ratio was 0.74 (CI 0.60, 0.91) with a highly significant p-value of p=0,0046.<br />
<br />
Trastuzumab increased the median overall survival time by 2.7 months to 13.8 months (intent to treat patient group, defined as IHC3+ or FISH-positive, represented 22% of patients tested for HER2 in the ToGA study). The response rate was increased with trastuzumab from 34.5 % to 47.3%. Patients with tumors exhibiting high levels of HER2 (IHC3+ or IHC2+/FISH-positive, 16% of patients tested for HER2 in the ToGA study) experienced even greater benefit from the addition of trastuzumab. For these patients, overall survival in the study was 16 months on average versus 11.8 months for patients receiving chemotherapy alone. The EU label recommends trastuzumab for patients expressing high levels of HER2.<br />
<br />
<b>Personalized Healthcare: Fitting treatments to patients</b><br />
Different people respond differently to medicines. The aim of aim of a personalized approach to healthcare is to target treatments to the patients most likely to benefit. This means tailoring treatments to specific patient sub-groups who share similar characteristics in their genetic makeup or in the molecular nature of their disease. This approach has enormous potential to make healthcare better, safer and more effective, with benefits for patients, physicians, payers, and society at large.<br />
<br />
Trastuzumab treatment in breast cancer is a case in point: Measuring the levels of the protein HER2 in breast cancer cells with specific tests reliably identifies patients who are likely to respond to trastuzumab. The same approach can also be applied in the diagnosis and the treatment of HER2-positive metastatic gastric cancer with trastuzumab.<br />
<br />
<i>References</i><br />
[1]Van Cutsem et al. Abstract #7BA ECCO/ESMO 2009<br />
[2]American Cancer Society. Global Cancer Facts & Figures 2007<br />
[3] Ohtsu A. J Gastroenterol 2008;43:256-264<br />
[4] Hofmann M, Stoss O, Shi D, Buttner R, van d, V, Kim W et al. Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology 2008; 52(7):797-805.<br />
[5] Park DI, Yun JW, Park JH, Oh SJ, Kim HJ, Cho YK et al. HER-2/neu amplification is an independent prognostic factor in gastric cancer. Dig Dis Sci 2006; 51(8):1371-1379.<br />
<br />
<i>Also:</i><br />
<ul><li><a href="http://oncozine.ning.com/" target="_blank">Onco’Zine – The International Cancer Network</a></li>
</ul><img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-65991927898033584062010-01-22T17:01:00.000-07:002010-01-30T17:39:02.324-07:00National Discussion on Proper Use and Support of Oral Chemotherapy in Cancer Care<span style="font-size: large;"><strong><em>The growing use of oral chemotherapeutics brings clinical benefits but also raises questions in prescribing, adherence, accessibility and long term follow-up care. </em></strong></span><br />
<br />
Therfore, US Oncology, Inc. partnered with the Association of Community Cancer Centers, Association of Oncology Social Work, American Society for Clinical Oncology, Community Oncology Alliance, Oncology Nursing Society and the National Patient Advocate Foundation in hosting a panel discussion on Capitol Hill to examine the benefits of oral chemotherapy in cancer care, as well as challenges in its prescribing, accessibility and adherence in the current health care system.<br />
<br />
"US Oncology recognizes the benefits of oral chemotherapy treatments and supports their use in that many patients have benefited from their convenience; ease of administration; and in some cases, lessened side effects when compared to traditional chemotherapy," said Leonard Kalman, M.D., Chairman of US Oncology's Public Policy Steering Committee. "As more patients request this therapy option, it is critical that patients and their physicians be fully informed and supported when it comes to effective prescribing, access to care and dosing adherence. We applaud our partners in the oncology community for coming together to address this issue."<br />
<br />
<strong>Oral Agent in Cancer Care</strong><br />
The panel discussion, entitled "Oral Agents in Cancer: Their Impact on the Treatment of Patients and Providers," featured perspectives from practicing medical oncologists, oncology nurses, oncology social workers and a chemotherapy patient who was unable to access her prescribed oral chemotherapy medication following an insurance coverage denial. As the panelists explained, all healthcare stakeholders must work together to ensure that these life-saving treatments are properly prescribed and administered, effectively covered and financially obtainable for patients as the oral chemotherapeutics market grows.<br />
<br />
US Oncology's OncologyRx Care Advantage™ national oral oncology specialty pharmacy service provides this type of financial, administrative and clinical support to cancer patients in need. By working directly with various charitable foundations, the program has provided more than $15 million in drug co-pay assistance to cancer patients since its inception in August 2006. OncologyRx Care Advantage also provides home delivery of prescribed oral cancer therapies, utilizes oncology certified nurses to proactively monitor patient compliance and help manage side effects, and gives patients 24-hour access to oncology certified pharmacists to answer their medication and dosing questions.<br />
<br />
<strong>Patient Adherence</strong><br />
With intravenous chemotherapy, cancer care providers are able to monitor treatment on site and ensure that patients properly follow to their dosing amount and schedule. However, when patients take their own oral chemotherapy treatments at home, other factors may come into play, such as forgotten doses, omitted doses, emotional factors and other priorities. Adequate patient education and follow-up are critical to make certain patients receive the full treatment they need.<br />
<br />
Healthcare providers play a unique and important role in assisting patients' healthy behavior changes. Panelists noted that widespread success in oral chemotherapy treatment will call for improved patient access to treatments; a new level of integration in care among physicians, pharmacists and other clinicians involved with the patient's care; and a new infrastructure in care for prescribing, education and support.<br />
<br />
The problem of poor adherence has been a well-recognized problem [1,2,3,4]. Research investigating the effects of nonadherence suggest that in the United States alone, every year more than 125,000 deaths are caused by this phenomenon, accounting for upwards of 10% to 25% of all hospital and nursing home admissions. [5]. These numbers suggest that a patient’s poor or nonadherence is one of the largest and most expensive disease categories in the US. But patient nonadherence is not limited to medications alone. Patients may ‘forget’ to keep their appointments, to follow recommended dietary, adhere to other lifestyle changes, or fail to follow – in some case deliberately sabotage - other aspects of treatment or recommended preventive health practices. As a result, the actual implications of nonadherence go far beyond the financial aspect of patients’ failing to take medication.<br />
<br />
"As more cancer patients are likely to look to oral chemotherapy as a more convenient and less invasive treatment option, we need to ensure that systematically, we are ready to meet their needs and providers' needs in terms of ready access to treatment; comprehensive information; and full administrative, clinical and social support throughout the course of treatment," added Dr. Kalman. "We look to the steps we have taken with OncologyRx Care Advantage as a model for this type of support, and we hope the broader healthcare community and policymakers will join us in exploring similar strategies to advance treatment success more broadly in this important area of care."<br />
<br />
<strong>For more information</strong><br />
[1] Haynes RB. Introduction. In: Haynes RB, Taylor DW, Sackett DL, eds. Compliance in Health Care. Baltimore, Md: Johns Hopkins University Press; 1979:1-18.<br />
[2] Blackwell B. Drug therapy: patient compliance. N Engl J Med. 1973;289:249-252.<br />
[3] Fawcett J. Compliance: definitions and key issues. J Clin Psychiatry. 1995;56(suppl1):4-8.<br />
[4]Davis MS. Variation in patients' compliance with doctors' orders: medical practice and doctor-patient interaction. Psychiatry Med. 1971;2:31-54.<br />
[5] Smith DL. Compliance packaging: a patient education tool. Am Pharm. 1989;NS29(2):42-45, 49-53.<br />
<br />
<i>Also:</i><br />
<ul><li><a href="http://oncozine.ning.com/" target="_blank">Onco’Zine – The International Cancer Network</a></li>
</ul><img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-52952314540839772212010-01-22T17:00:00.002-07:002010-01-30T17:33:30.386-07:00Studies Show Benefit of Advance Detection and Treatment of Gastrointestinal Cancers<strong><em><span style="font-size: large;">A great number of the world's preeminent gastroenterologists will gather during the seventh annual Gastrointestinal Cancers Symposium (ASCO GI) from January 22-24, 2010, at the Orlando World Center Marriott to discuss new research on the treatment of gastrointestinal cancers.</span></em></strong><br />
<br />
<br />
Presentations at the meeting will focus on detection and treatment of gastrointestinal cancers, which includes cancers of the colon/rectum, stomach, pancreas, esophagus, small intestine, anus and other digestive organs. More than 275,000 people in the U.S. are diagnosed with these cancers each year, and nearly 136,000 people die from them. The Gastrointestinal Cancers Symposium is co-sponsored by the American Gastroenterological Association (AGA) Institute, the American Society for Clinical Oncology (ASCO), the American Society for Radiology Oncology (ASTRO) and the Society of Surgical Oncology (SSO).<br />
<br />
Highlights from this year Scientific Meeting include the result of four significant studies:<br />
<br />
<strong>Simple blood test detects colorectal cancer and colorectal adenomas</strong><br />
A new test for blood levels of the CD24 protein is more than 90 percent sensitive and specific for detecting colorectal cancer, and more than 80 percent accurate at detecting potential precancers, called adenomas. These findings may prove useful for identifying patients who would benefit most from colonoscopy.<br />
<br />
<strong>New test for early detection of pancreatic cancer</strong><br />
Researchers report on a promising immunoassay that detects early-stage pancreatic cancers with a high degree of accuracy. The assay identifies and quantifies blood levels of the PAM4 protein – a unique antigen present in almost 90 percent of pancreatic cancers and precancers. Pancreatic cancer is typically diagnosed at a late stage, when it is more difficult to treat.<br />
<strong>Inherited gene variation predicts aggressive gastric cancer</strong><br />
For the first time, researchers report the identification of an inherited genetic variation – located on the CD44 gene – that is linked to increased risk of recurrence in patients with gastric (stomach) cancer.<br />
<br />
<strong>Adjuvant XELOX chemotherapy regimen slows colon cancer progression in patients of all ages, including those 70+</strong><br />
Adjuvant (post-surgical) treatment with capecitabine and oxaliplatin (XELOX) is more effective than standard 5-fluorouracil and leucovorin (5-FU/LV) for slowing the progression of stage III colon cancer among patients of all ages, including those age 70 and older – findings that may prompt more aggressive treatment for older patients in otherwise good health.<br />
“Growing understanding of molecular biology has helped us make enormous progress in screening, detection and treatment for gastrointestinal cancers,” said Robert P. Sticca, MD, Chairman of the Department of Surgery and Professor at the University of North Dakota School of Medicine and Health Sciences. “These studies describe long-awaited approaches, such as an early detection test for pancreatic cancer and a blood test for colon cancer. Other studies presented during the annual symposium will help us to better personalize treatment for gastric and colon cancers based on patients’ age and genetic factors.”<br />
<br />
<i>Also:</i><br />
<ul><li><a href="http://oncozine.ning.com/" target="_blank">Onco’Zine – The International Cancer Network</a></li>
</ul><img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com1tag:blogger.com,1999:blog-5162684219865162218.post-64622963636767144742009-12-17T17:26:00.001-07:002009-12-17T17:28:52.656-07:00Brachytherapy Used for the First Time in United States to Treat Lung Cancer<i><b><span style="font-size: large;">A 58-year-old man who lives in Corona, Queens came to the emergency room of New York Hospital Queens (NYHQ) with extreme pain and tingling in his left arm. Although he did not realize it at the time, he had lung cancer. Recently, he made medical history as the first patient in the United States to be treated for lung cancer through the use of radioactive pellets placed directly in the tumor, and today his recovery is going well. Known as brachytherapy, this treatment approach is commonly used to treat prostate cancer.</span></b></i><br />
<br />
"Although the patient came in because of pain in his arm, it was not due to an injury. It was discovered that the cause was a Pancoast tumor, a tumor in the lungs that affects the arms and shoulders but rarely causes symptoms, such as cough or shortness of breath, typically associated with the lungs," according to Dattatreyudu Nori, M.D., chairman, Radiation Oncology and one of the world's leading authorities in the subspecialty of brachytherapy.<br />
<br />
Pancoast tumors form at the extreme pulmonary apex of either the right or left lung in the superior sulcus. The initial symptom is severe and constant pain in the shoulder, inner part of the scapula, or both.<br />
<br />
In addition to general cancer symptoms such as malaise, fever, weight loss and fatigue, pancoast tumor may include a complete Horner’s syndrome caused by damage to the sympathetic nervous system, and in severe and progressive cases, miosis, anhidrosis, ptosis, and brachial plexus.<br />
<br />
Dr Nori was the first physician in the United States to work with a computerized brachytherapy treatment system and was instrumental in the development and successful application of it to combat cancer.<br />
<br />
The patient was treated with high dose chemotherapy and then underwent treatment with external beam radiation. Although he did have some positive response, the tumor was still present. Because of the location of the tumor, the NYHQ physicians knew that additional conventional treatment could endanger surrounding critical structures including nerves and vessels, and could affect the other organs of his body.<br />
<br />
With the options becoming limited, Dr. Nori, along with colleague Paul C. Lee, M.D., the hospital's vice chairman of cardiothoracic surgery, decided to perform a surgical resection of the tumor and then implanted the tumor bed with radioactive Cesium 131 pellets - in a new type of brachytherapy procedure. Brachytherapy involves the implantation of radioactive seeds into the tumor site to kill the remaining cancer cells after surgical resection, while limiting the damage to healthy tissue. Brachytherapy has been successful in treating prostate cancer, but had never been used to treat this form of aggressive lung cancer.<br />
<br />
"The tumor was very aggressive. We decided to use radioactive Cesium-131 pellets due to their high success rate in treating prostate cancer. This patient has responded well to the treatment, with an outcome that would not have been possible with traditional treatment," reports Dr. Nori.<br />
<br />
According to Dr. Nori, Cesium-131 pellets have several advantages over the older radioactive isotopes including a shorter half-life, which means faster delivery of a radiation dose that allows less time and opportunity for the cancer cells to repopulate.<br />
<br />
Dr. Nori has trained several hundred physicians in the U.S. on the use of brachytherapy procedures in the treatment of cancer, and more recently on the use of Cesium-131 in lung cancer treatment. He is renowned in the field of radiation oncology and for pioneering the use of use of radioactive isotopes to treat prostate cancer. He was one of the first to use the radioactive isotopes Iodine-125 and Palladium-103 in 1975 and 1985 as well as Cesium-131, which was approved by the U.S. Food and Drug Administration (FDA) in 2003 for treating prostate and other cancers.<br />
<br />
New York Hospital Queens is a member of the New York-Presbyterian Healthcare System and an affiliate of the Weill Medical College of Cornell University.<br />
<br />
<i>For more information:</i><br />
<ul><li>Ziyade S, Soysal O, Ugurlucan M, Yediyildiz S. <a href="http://www.ncbi.nlm.nih.gov/pubmed/19765540" target="_blank">Pancoast hydatid cyst leading to horner syndrome: thoracic hydatidosis.</a> Heart Lung Circ. 2009 Oct;18(5):363-4. Epub 2008 Jul 26.</li>
<li>Fontinele e Silva J, Barbosa Mde P, Viegas CL. <a href="http://www.ncbi.nlm.nih.gov/pubmed/19287924" target="_blank">Small cell carcinoma in Pancoast syndrome</a> J Bras Pneumol. 2009 Feb;35(2):190-3.</li>
<li>Nag S, Kelly JF, Horton JL, Komaki R, Nori D. <a href="http://www.ncbi.nlm.nih.gov/pubmed/11301833" target="_blank">Brachytherapy for carcinoma of the lung.</a> Oncology (Williston Park). 2001 Mar;15(3):371-81.</li>
<li>Hilaris BS, Martini N, Wong GY, Nori D. <a href="http://www.ncbi.nlm.nih.gov/pubmed/3629433" target="_blank">Treatment of superior sulcus tumor (Pancoast tumor).</a> Surg Clin North Am. 1987 Oct;67(5):965-77.</li>
</ul><i>Also:</i><br />
<ul><li><a href="http://oncozine.ning.com/" target="_blank">Onco’Zine – The International Cancer Blog</a></li>
</ul><img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-48455246686417153982009-12-16T13:43:00.002-07:002009-12-16T15:38:14.791-07:00Denosumab Superior to Zoledronic Acid in Reducing Incidence of Skeletal-Related Events in Breast Cancer Patients with Bone Metastases<span style="font-size: large;"><em><i><b>Data Presented at earlier this month at the San Antonio Breast Cancer Symposium demonstrates that treatment with denosumab, a new drug in late stage clinical development, is superior to the standard of care in advanced breast cancer patients. Among patients with bone metastasis from breast cancer, denosumab was superior to zoledronic acid in reducing the incidence of complications from bone metastases.</b></i></em></span><br />
<br />
"Denosumab prevented more events, was better tolerated and is more convenient for patients," said Alison Stopeck, M.D., associate professor of medicine at the <a href="http://www.azcc.arizona.edu/" target="_blank">University of Arizona Cancer Center</a> who presented the results of this phase III, double blind study at the 2009 CTRC-AACR <a href="http://www.sabcs.org/" target="_blank">San Antonio Breast Cancer Symposium</a>.<br />
<br />
Stopeck and colleagues enrolled 2,048 patients with bone metastasis who had never received treatment with intravenous bisphosphonates. They randomly assigned patients to treatment with 120 mg subcutaneous denosumab (Amgen) or 4 mg intravenous zoledronic acid (<a href="http://www.us.zometa.com/" target="_blank">Zometa, Novartis</a>) every four weeks.<br />
<br />
Denosumab, is an investigational first fully <a href="http://www.accessexcellence.org/RC/AB/IE/Monoclonal_Antibody.php" target="_blank">human monoclonal antibody</a> developed by Amgen. It works differently from existing bone treatments by specifically targeting a protein called <a href="http://www.rankligand.com/" target="_blank">RANK Ligand</a> (RANKL), which plays an important role in regulating osteoclast activity and function and has been linked with increased bone loss and complications from bone metastases.<br />
<br />
Stopeck presented data confirming that denosumab significantly delayed time to first on-study skeletal-related event compared with zoledronic acid (HR=0.82; 95% CI, 0.71-0.95), as well as time to first, and subsequent, on-study skeletal-related event (rate ratio=0.77; 95% CI, 0.66-0.89). In this study, patients assigned to denosumab had 491 skeletal-related events compared with 623 for patients assigned to zoledronic acid.<br />
<br />
"In clinical trials testing new medications for bone metastases, treatment success is measured by whether the bone complications, or skeletal related events, caused by the tumor are reduced or delayed," Stopeck explained. "Skeletal complications from bone metastases are a critical and painful health concern for patients with advanced breast cancer, and can increase the risk of mortality. Patients who have a first skeletal related event are twice as likely to experience a subsequent SRE, so it is imperative to treat these advanced breast cancer patients."<br />
<br />
“Denosumab resulted in a considerable delay in the development of moderate-to-severe pain compared to zoledronic acid,” Stopeck said.<br />
<br />
Additional data from this study showed that denosumab significantly reduced the mean annual skeletal morbidity rate (SMR) (the ratio of the number of skeletal complications to the time on trial) compared with Zometa (0.45 vs. 0.58, respectively; p=0.004).<br />
<br />
Overall, the incidence of adverse events (96% denosumab, 97% zoledronic acid) and serious adverse events (44% denosumab, 46% zoledronic acid) was consistent with what has previously been reported for these two agents. Adverse events potentially associated with acute phase reactions during the first three days of the study were reported in 10.4 percent of the denosumab arm and 27.3% of the zoledronic acid arm. Adverse events potentially associated with renal toxicity occurred in 4.9% of patients treated with denosumab compared to 8.5% in patients treated with zoledronic acid.<br />
<br />
Osteonecrosis of the jaw (ONJ) was seen infrequently in both treatment groups (20 patients receiving denosumab [2.0%] as compared with 14 patients [1.4%t] receiving Zometa). Rates of new primary malignancies were similar between treatment arms (5 patients receiving denosumab [0.5%] and 5 receiving zoledronic acid [0.5%]). Time to disease progression or overall survival was balanced between the study arms.<br />
<br />
At 34 months, 30.7% of patients treated with denosumab arm experienced at least one skeletal-related event (95% CI, 33.5%-39.4%) compared with 36.5% of those treated with zoledronic acid. Denosumab also reduced mean skeletal morbidity rate (0.45 vs. 0.58; P=.004).<br />
<br />
<i>Clinical relevance</i><br />
Bone metastases, cancer cells that separate from tumors and migrate to bone tissue where they settle and grow, occur in more than 1.5 million people worldwide. With improvements in cancer care, including earlier diagnosis and new treatment options, leading to increases in survival rates, the number of patients developing metastatic disease secondary to a primary cancer is increasing. Bone metastases are a significant problem for patients with certain types of advanced cancer, with incidence rates of nearly 100 percent in myeloma patients and as high as 75 percent in breast and prostate cancer patients.<br />
<br />
With bone metastases the growing cancer cells weaken and destroy the bone around the tumor. The damage the tumor has caused to the bone can result in a number of serious complications, collectively called SREs. These include fracture of a bone, the need for radiation to bone, the need for bone surgery, or spinal cord compression. All are serious complications for advanced cancer patients.<br />
<br />
The economic burden of United States (U.S.) patients with bone metastases is significant and was estimated to be $12.6 billion last year. Patients with bone metastases who experience an SRE incur significantly higher medical costs compared with those who do not experience an SRE.<br />
<br />
The results of this study are therefore clinically relevant. Before the availability of bisphosphonates 64% patients with breast cancer with bone metastases generally developed a skeletal-related event, including fracture or pain. With the introduction of Bisphosphonates, this was reduced this to 43%. Today, with more potent agents such as zoledronic acid, the development of skeletal-related event are less than 34%. The results of this trial comparing denosumab vs zoledronic acid shows further improvement with a 27% reduction of incidence rate.<br />
<br />
This oral presentation of the denosumab 136 data by Dr. Alison Stopeck was presented at the 2009 CTRC-AACR San Antonio Breast Cancer Symposium. on Thursday, December 10 at 3:15 PM (CT) in Exhibit Hall D of the Henry B. Gonzalez Convention Center, San Antonio, Texas.<br />
<br />
<i>For more information</i><br />
<ul><li>Downey L, Livingstone R, Stopeck A. <a href="http://www.ncbi.nlm.nih.gov/pubmed/17727649" target="_blank">Diagnosing and treating breast cancer in elderly women: a call for improved understanding.</a> J Am Geriatr Soc 2007 Oct;55(10):1636-44. Epub 2007 Aug 28.</li>
<li>Coleman R. <a href="http://www.ncbi.nlm.nih.gov/pubmed/17683651" target="_blank">Potential use of bisphosphonates in the prevention of metastases in early-stage breast cancer.</a> Clin Breast Cancer 2007 Jul;7 Suppl 1:S29-35</li>
<li>Coleman R. <a href="http://www.ncbi.nlm.nih.gov/pubmed/17988867" target="_blank">On the horizon: can bisphosphonates prevent bone metastases?</a> Breast. 2007 Dec;16 Suppl 3:S21-7. Epub 2007 Nov 7. Review.</li>
<li>Coleman RE. <a href="http://www.ncbi.nlm.nih.gov/pubmed/18240670" target="_blank">The benefits and costs of bisphosphonates.</a> J Support Oncol 2007 Nov-Dec;5(10):483-4.</li>
<li>Brown JE, Coleman RE. <a href="http://www.ncbi.nlm.nih.gov/pubmed/11879556" target="_blank">The present and future role of bisphosphonates in the management of patients with breast cancer.</a> Breast Cancer Res. 2002;4(1):24-9. Epub 2001 Nov 26. Review.</li>
<li>Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, et al. <a href="http://www.ncbi.nlm.nih.gov/pubmed/11693896" target="_blank">Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial</a>. Cancer J. 2001 Sep-Oct;7(5):377-87.</li>
<li>Coleman RE. <a href="http://www.ncbi.nlm.nih.gov/pubmed/11417967" target="_blank">Metastatic bone disease: clinical features, pathophysiology and treatment strategies.</a> Cancer Treat Rev. 2001 Jun;27(3):165-76. Review.</li>
<li>Capanna R, Coia LR, Coleman R. et al. eds. <a href="http://www.amazon.com/gp/product/0471877425?ie=UTF8&tag=thevisualconsult&linkCode=as2&camp=1789&creative=9325&creativeASIN=0471877425">Textbook of Bone Metastases</a><img alt="" border="0" height="1" src="http://www.assoc-amazon.com/e/ir?t=thevisualconsult&l=as2&o=1&a=0471877425" style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; margin: 0px;" width="1" /> Hoboken, NJ: Edition: John Wiley and Sons; 2005:105.</li>
<li>Mundy GR. <a href="http://www.ncbi.nlm.nih.gov/pubmed/12154351" target="_blank">Metastasis to bone: causes, consequences and therapeutic opportunities.</a> Nat Rev Cancer. 2002 Aug;2(8):584-93. Review</li>
<li>Schulman KL, Kohles J. <a href="http://www.ncbi.nlm.nih.gov/pubmed/17450591" target="_blank">Economic burden of metastatic bone disease in the U.S.</a> Cancer. 2007 Jun 1;109(11):2334-42.</li>
<li>Mortimer JE, Schulman K, Kohles JD. <a href="http://www.ncbi.nlm.nih.gov/pubmed/17919348" target="_blank">Patterns of bisphosphonate use in the United States in the treatment of metastatic bone disease.</a> Clin Breast Cancer. 2007 Aug;7(9):682-9.</li>
</ul><em>Also follow</em><br />
<ul><li><a href="http://oncozine.ning.com/" target="_blank">Onco'Zine - The International Cancer Network</a></li>
</ul><img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-18666600633246484022009-12-15T22:33:00.001-07:002009-12-15T22:35:54.822-07:00Oral Bisphosphonates May Significantly Reduce Breast Cancer<i><span style="font-size: large;"><strong>Results of a new analysis of data from the </strong></span><a href="http://www.nhlbi.nih.gov/whi/" target="_blank"><span style="font-size: large;"><strong>Women's Health Initiative</strong></span></a><span style="font-size: large;"><strong> (WHI) observational study showed that women who used bisphosphonates, which are commonly prescribed bone-strengthening pills, had significantly fewer invasive breast cancers than women who did not use bisphosphonates. These findings were presented at the CRTC-AACR </strong></span><a href="http://www.sabcs.org/" target="_blank"><span style="font-size: large;"><strong>San Antonio Breast Cancer Symposium</strong></span></a><span style="font-size: large;"><strong>.</strong></span></i><br />
<br />
In the 150,000-plus cohort of generally healthy postmenopausal women, the researchers found that women who used bisphosphonates, mostly alendronate, which is sold as <a href="http://www.fosamax.com/" target="_blank">Fosamax (alendronate sodium)</a> by Merck, had 32% fewer cases of invasive breast cancer compared to women who did not use such drugs.<br />
<br />
"The idea that bisphosphonates could reduce breast cancer incidence is very exciting because there are about 30 million prescriptions for these agents written annually in the United States targeting bone health, and more could easily be used to counteract both osteoporosis and breast cancer," said the study's lead investigator, Rowan Chlebowski, M.D., Ph.D., medical oncologist at the <a href="http://www.labiomed.org/" target="_blank">Los Angeles Biomedical Research Institute</a> at Harbor-University of California, Los Angeles Medical Center.<br />
<br />
The concept arose from findings in a report on an adjuvant breast cancer trial where use of the bisphosphonate zoledronic acid given intravenously every six months resulted in fewer contralateral breast cancers.<br />
<br />
"It appeared to make bone less hospitable to breast cancer," Chlebowski said.<br />
<br />
However, since bisphosphonates are prescribed for women with low bone mineral density and low bone mineral density has been associated with lower breast cancer incidence, a means to control for potential differences between women prescribed bisphosphonate and those not prescribed bisphosphonate in the cohort was needed.<br />
<br />
Given that, Chlebowski and colleagues devised a way to control for use of bisphosphonates in the WHI. About 10,000 of the participants had bone mineral density analysis as part of the study, and for the rest they used a 10-item hip fracture predictive score to measure bone density. The researchers were able to correlate the findings from the women who had bone mineral density tests to findings from the predictive score in order to correct for any potential difference in bone density in women using bisphosphonates compared to non-users.<br />
<br />
Studying 2,216 WHI participants who were using bisphosphonates when they entered the study, the researchers found that only 64 women developed breast cancer, and most of those cases (50) were estrogen receptor positive. Overall, there was a mean 32 percent fewer breast cancers in women using bisphosphonates compared to women who did not. There were 30 percent fewer estrogen receptor-positive cancers and 34 percent fewer entry receptor-negative cancers in bisphosphonate users. The latter finding was not statistically significant as there were very few receptor-negative cases.<br />
<div><br />
</div>"Bisphosphonates reduce angiogenesis and stimulate immune cells responsible for tumor cell surveillance as potential mediators," Chlebowski said. "This association needs to be studied further. While we currently have several options for reducing receptor-positive breast cancers, none are available for receptor-negative cancers."<br />
<br />
Several ongoing adjuvant breast cancer trials evaluating oral and intravenous bisphosphonate will be available in the near future to provide randomized clinical trial evidence regarding their influence on new contralateral breast cancer risk, Chlebowski said.<br />
<br />
<em>For more information:</em><br />
<ul><li> <a href="http://oncozine.ning.com/" target="_blank">Onco'Zine - The International Cancer Network</a></li>
</ul><br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-15132271283522271802009-12-15T10:30:00.000-07:002009-12-16T10:48:40.279-07:00Bisphosphonates and the Risk of Postmenopausal Breast Cancer<i><b><span style="font-size: large;">Bisphosphonates are routinely given to women with postmenopausal breast cancer, but new data suggest that these agents may play an important role in reducing recurrent breast cancer as well. Results of a new trial demonstrated that the use of bisphosphonates was associated with a 29% reduction in the risk of postmenopausal breast cancer. The results were presented at the CTRC-AACR </span><a href="http://www.sabcs.org/" target="_blank"><span style="font-size: large;">San Antonio Breast Cancer Symposium</span></a><span style="font-size: large;">.</span></b></i><br />
<br />
<i>Link between Bisphosphonates and Breast Cancer</i><br />
When breast cancer metastasizes, it often spreads first to the bones. Bone metastases can lead to complications such as pain, fractures, spinal cord compression, bone marrow suppression, and hypercalcemia. The primary reason for this link is that breast cancer cells stimulate bone cells called osteoclasts, and these osteoclasts in turn stimulate the growth of breast cancer cells.<br />
<br />
Bisphosphonates have emerged as a highly effective therapeutic option for the prevention of skeletal complications secondary to bone metastases. They interrupt the relationship between osteoclasts and breast cancer cells in early stage breast cancer, slowing the progression of bone metastases while, at the same time, reducing the skeletal complications in women with metastatic breast cancer. Research has also demonstrated that bisphosphonates may prevent the development of bone metastases in newly diagnosed patients with no evidence of metastasis.<br />
<br />
A number of agents are now approved in both Europe and the US. They included <a href="http://www.bayer.com.au/html/images/upload/CMIs/2009/november/BONEFOS_CMI.pdf" target="_blank">Clodronate</a>, Pamidronate, Ibandronate, <a href="http://www.emea.europa.eu/humandocs/PDFs/EPAR/zometa/021101en1.pdf" target="_blank">Zoledronic acid</a>.<br />
<br />
<i>New and ongoing research</i><br />
Lead researcher Gad Rennert, M.D., Ph.D., chairman of the Department of Community Medicine and Epidemiology at the <a href="http://www.hospitalsoup.com/listing/47640-carmel-medical-center" target="_blank">Carmel Medical Center</a> of <a href="http://www.clalit.co.il/HE-IL/english" target="_blank">Clalit Health Services</a> and a faculty member at the <a href="http://www1.technion.ac.il/" target="_blank">Technion-Israel Institute of Technology</a> in Israel, said these data help shed light on a possible new pathway for breast cancer prevention.<br />
<br />
"We have identified a new class of drugs that is associated with a reduced risk of breast cancer, and if proven in randomized trials, we may be able to recommend it to postmenopausal women for this purpose," said Rennert.<br />
<br />
Rennert and colleagues extracted data from the Breast Cancer in Northern Israel Study, which is a population-based, case-control study. They evaluated the use of bisphosphonates for at least five years in 4,575 postmenopausal study participants using a structured interview. The self-reported, long-term use of bisphosphonates prior to diagnosis was associated with a significant reduced relative risk for breast cancer by approximately 34%.<br />
<br />
This reduction remained significant, at 29%, even after adjusting for a large variety of risk factors for breast cancer such as age, fruit and vegetable consumption, sports activity, family history of breast cancer, ethnic group, body mass index, calcium supplement and hormone replacement therapy use, number of pregnancies, months of breastfeeding and age at first pregnancy.<br />
<br />
Moreover, the breast tumors identified among patients who used bisphosphonates were more often estrogen receptor positive and less often poorly differentiated.<br />
<br />
"These tumors are the type that are associated with a better prognosis," said Rennert.<br />
<br />
While most experts are cautiously optimistic about the results of this study, several of them said that more information is necessary, and as of now, they would not suggest the use of bisphosphonates for women who do not have osteoporosis.<br />
<br />
<i>For more information:</i><br />
<ul><li>Coleman RE. <a href="http://www.ncbi.nlm.nih.gov/pubmed/15802276" target="_blank">Bisphosphonates in breast cancer</a>. Ann Oncol 2005 May;16(5):687-95. Epub 2005 Mar 31.</li>
<li>Logman JF, Heeg BM, Botteman MF, Kaura S, van Hout BA. <a href="http://www.ncbi.nlm.nih.gov/pubmed/19955334" target="_blank">Economic evaluation of zoledronic acid for the prevention of osteoporotic fractures in postmenopausal women with early-stage breast cancer receiving aromatase inhibitors in the UK.</a> Ann Oncol. 2009 Dec 2. [Epub ahead of print]</li>
<li>Ghazi M, Roux C. <a href="http://www.ncbi.nlm.nih.gov/pubmed/19945692" target="_blank">Hormonal deprivation therapy-induced osteoporosis in postmenopausal women with breast cancer.</a> Best Pract Res Clin Rheumatol. 2009 Dec;23(6):805-11.</li>
<li>Theriault RL. <a href="http://www.ncbi.nlm.nih.gov/pubmed/19934757" target="_blank">Bisphosphonates: ready for use as adjuvant therapy of breast cancer?</a> Curr Opin Obstet Gynecol. 2009 Nov 19. [Epub ahead of print]</li>
</ul><i>Also see:</i><br />
<ul><li><a href="http://oncozine.ning.com/" target="_blank">Onco'Zine - The International cancer Blog</a></li>
</ul><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-35394993876633683302009-12-14T22:25:00.004-07:002009-12-15T21:49:45.987-07:00New Drug Targeting Advanced Thymic Cancer May Bring Hope to Patients<i><span style="font-size: large;"><strong>The Translational Genomics Research Institute (TGen), a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking medical research in oncology, neurological disorders and diabetes, and Scottsdale Healthcare are testing a new drug specifically for thymic cancer. The new drug candidate is designed to stop abnormal cell division and duplication, a common feature of cancer.</strong> <br />
</span></i><br />
<br />
The thymus, a small organ that lies in the upper chest under the breastbone or sternum. As a part of the lymph system, the thymus makes lymphocytes that protect the body against infections. <br />
There are different types of tumors of the thymus. Both thymomas (or Thymic epithelial tumors) with clearcut cytologic features of malignancy and thymic carcinomas are rare tumors of the cells that are on the outside surface of the thymus. The tumor cells in a thymoma look similar to the normal cells of the thymus, grow slowly, and rarely spread beyond the thymus. On the other hand, the tumor cells in a thymic carcinoma look very different from the normal cells of the thymus, grow more quickly, and have usually spread to other parts of the body when the cancer is found. Thymic carcinoma is more difficult to treat than thymoma.<br />
<br />
At the time of diagnosis, thymic carcinoma has usually metastasized. This can make formulating a treatment plan more challenging. Surgical removal of the tumor is usually the first line of therapy. Depending on the stage of the cancer at diagnosis, chemotherapy, hormone therapy, and radiation may also be prescribed. The 10-year survival rate for patients diagnosed with thymic carcinoma is approximately 28%.<br />
<br />
Thymic carcinoma often goes unnoticed until the tumor begins to press on the patient's windpipe. It can also produce hormones that frequently cause symptoms. These may include a persistent cough, asthma, swelling of the face, diarrhea, red and warm skin, and chest pain. Some patients may have no symptoms of the cancer at all. In these cases, the tumor may have been an incidental finding on a routine chest x-ray. <br />
<br />
Preliminary results of PHA-848125AC, a TRK A antagonist pro, is uced by <a href="http://www.nervianoms.com/cont/en/home-page/0705/2500/homepage.asp" target="_blank">Nerviano Medical Sciences</a> of Milan, Italy’s largest pharmaceutical research and development facility, showed favorable results in treating the disease. <br />
<br />
“From the initial trial in patients with advanced cancers, this drug is well tolerated. We are now focusing on thymic cancer based on our initial results, to hopefully find a treatment that is successful for this rare cancer - where there is no standard approved treatment,” said Dr. Glen J. Weiss, principal investigator for this trial and Director of Thoracic Oncology at TGen Clinical Research Services (TCRS) at Scottsdale Healthcare. <br />
<br />
TCRS is a partnership between TGen and Scottsdale Healthcare that enables laboratory discoveries to be quickly turned into targeted therapies that can be tested with patients at the Virginia G. Piper Cancer Center in Scottsdale.<br />
<br />
This Phase II clinical trial of as many as 60 adults with advanced thymic cancer will help determine if PHA-848125AC is an active drug for this disease. The thymus is a small organ near the lungs and heart that is a key part of the body’s immune system during fetal and childhood development. <br />
<br />
Dr. Jeffrey Isaacs of <a href="http://www.sho.md/home/" target="_blank">Southwest Hematology Oncology</a> in Phoenix, has seen first-hand how this agent made a difference for patients with thymic cancer. He said he is enthusiastic about a drug specifically targeting this rare cancer population to hopefully improve their outcomes. <br />
<br />
PHA-848125AC will be administered orally. The study will be open at Scottsdale Healthcare, the <a href="http://www.igr.fr/" target="_blank">Institute Gustave Roussy</a> and the <a href="http://www.chu-toulouse.fr/-hopital-larrey-" target="_blank">Hopital Larrey</a> in France and at the University of Turin, <a href="http://www.paginegialle.it/sanluigigonzaga" target="_blank">San Luigi Hospital</a> in Italy. <br />
<br />
The intent of <a href="http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01011439" target="_blank">the study</a> is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy. Patients will receive 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle until disease progression or unacceptable toxicity will develop.<br />
<br />
<em>For more information about current clinical trials:</em><br />
<br />
<ul><li><a href="http://clinicaltrials.gov/ct2/show/NCT01011439" target="_blank">Phase II Study</a> Of Oral PHA-848125AC In Patients With Thymic Carcinoma</li>
</ul><em>Also read</em><br />
<ul><li>Johnson S B et al. Thymoma: Update for the new millennium. The Oncologist. Vol. 6, No 3, 239- 246, June 2001.</li>
<li>Lara, Jr P N (2000) Malignant thymoma: current status and future directions. Cancer Treatment Reviews April 2000; 26: 2 127-131.</li>
<li>Detterbeck FC, Parsons A M Thymic Tumours. The Annals of Thoracic Surgery 2004; 77:1860- 9.</li>
<li>Eng T et al (2003) Thymic carcinoma: state of the art review. International Journal of Radiation Oncology Biology Physics. Vol 59 No 3.</li>
<li>Giaccone G Treatment of malignant thymoma. Current Opinion in Oncology 2005 17: 140- 146.</li>
<li>World Health Organisation classification of tumours. Pathology and genetics. Tumours of the lung, pleura, thymus and heart. World Health Organisation Classification of Tumours Vol.10 Eds. Travis WD et al. WHO Press, 2004.</li>
<li>Textbook of Uncommon Cancer (3rd edition) Eds. Raghavan et al. Wiley, 2006. </li>
</ul><em>See PubMed abstracts:</em><br />
<br />
<ul><li>Nakagawara A <a href="http://www.ncbi.nlm.nih.gov/pubmed/11431098" target="_blank">Trk receptor tyrosine kinases: a bridge between cancer and neural development</a> Cancer Lett.2001 Aug 28;169(2):107-14.</li>
<li>Mitsutake N, Yamashita S <a href="http://www.ncbi.nlm.nih.gov/pubmed/19894361" target="_blank">The role of cancer genes in thyroid cancer and molecular targeted therapy</a> Nippon Naika Gakkai Zasshi. 2009 Aug 10;98(8):1999-2005.</li>
</ul><br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-31563029452663388212009-12-12T21:00:00.003-07:002009-12-15T21:54:43.957-07:00Final Follow-Up of Z-FAST Study Shows Zoledronic Acid May Benefit Postmenopausal Woman with Aromatase Inhibitor-Associated Bone Loss<span style="font-size: large;"><strong><i><b>Zoledronic acid is both safe and effective in preventing bone loss in postmenopausal women with breast cancer who are treated with aromatase inhibitors, according to data presented at the CTRC-AACR <a href="http://www.sabcs.org/" target="_blank">San Antonio Breast Cancer Symposium</a>.</b></i></strong></span><br />
<br />
<span style="font-size: large;"><strong> </strong></span>"Women who take aromatase inhibitors need some sort of bone protection, and this five-year data show that <a href="http://www.us.zometa.com/" target="_blank">zoledronic acid</a> is a viable option," said Adam Brufsky, M.D., Ph.D., associate professor of medicine, associate chief of hematolgy-oncology, and associate director for clinical investigation, <a href="http://www.upci.upmc.edu/" target="_blank">University of Pittsburgh Cancer Institute</a>.<br />
<br />
Brufsky estimates that between 20,000 to 30,000 women a year will benefit from this therapy and that number is growing. Anastrozole, currently sold as <a href="http://www.arimidex.com/" target="_blank">Arimidex</a> by AstraZeneca, is scheduled to go off patent within the next few years.<br />
<br />
"Women who are on Medicare tend to go with tamoxifen because the cost of anastrozole puts them squarely in the donut hole of Medicare Part D, but once the cost barrier is removed there will likely be a mass switch to the aromatase inhibitor, which will necessitate the need for bone protection," said Brufsky.<br />
<br />
Beyond the aging population, use of zoledronic acid could increase even further if the signs that it prevents breast cancer recurrence continue in larger studies.<br />
<br />
Brufsky's study, Z-FAST (<a href="http://clinicaltrials.gov/ct2/show/NCT00050011" target="_blank">Zometa-Femara Adjuvant Synergy Trial</a>), focused on 602 postmenopausal women with stage I to IIIa estrogen or progesterone receptor-positive breast cancer. The researchers randomized patients to immediate zoledronic acid or delayed zoledronic acid. The delayed group received it only if the T-score dropped below two or a clinical fracture occurred.<br />
<br />
After five years, patients in the immediate treatment arm had a bone mineral density increase of 6.2% in their lumbar spine area, while those in the delayed arm had a decrease of 2.4%. In the hip area, the increase was 2.6% with immediate treatment compared with a 4.1% decrease with delayed treatment.<br />
<br />
Fractures occurred in 10.7% of the patients treated immediately and 12.4% of the patients who received delayed treatment. There were no serious renal events and no osteonecrosis of the jaw, which confirmed that the drug was safe and well tolerated.<br />
<br />
<em>For more information:</em><br />
<ul><li><a href="http://oncozine.ning.com/" target="_blank">Onco'Zine - The International Cancer Network</a><br />
</li>
</ul><img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-39568090431846464752009-12-12T20:00:00.006-07:002009-12-26T19:58:37.250-07:00DM1, an Investigational Antibody-Drug Conjugate, Shows Encouraging Results in Women With Highly Advanced HER2-positive Breast Cancer<i><b><span style="font-size: large;">Results of a Phase II study of trastuzumab (</span><a href="http://www.herceptin.com/hcp/index.jsp" target="_blank"><span style="font-size: large;">Herceptin®</span></a><span style="font-size: large;">, Genentech) in combination with DM1 (T-DM1), an investigational HER2 antibody-drug conjugate being developed by </span><a href="http://www.gene.com/" target="_blank"><span style="font-size: large;">Genentech</span></a><span style="font-size: large;">, in collaboration with </span><a href="http://www.roche.com/" target="_blank"><span style="font-size: large;">Roche</span></a><span style="font-size: large;"> and </span><a href="http://www.immunogen.com/wt/home/home" target="_blank"><span style="font-size: large;">Immunogen, Inc</span></a><span style="font-size: large;">., shows encouraging results in women with highly advanced HER2-positive breast cancer.</span></b></i><br />
<br />
Positive Phase I and Phase II findings were first reported at the 2007 [<a href="http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=47&abstractID=35356" target="_blank">1</a>] and 2008 [<a href="http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=35721" target="_blank">2</a>], respectively, annual meetings of the American Society of Clinical Oncology (ASCO) with T-DM1 in patients with HER2-positive (HER2+) metastatic breast cancer (MBC) that progressed on treatment with trastuzumab. In the Phase II study, 60% of patients also had been treated with lapatinib (<a href="http://www.tykerb.com/hcp/index.html" target="_blank">Tykerb®</a>, GlaxoSmithKline).<br />
<br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">As assessed by independent review, the T-DM1 combination shrank the tumors (also known as objective response) in 33% of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment. <br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjjQSq05nrCsvU-6Ii1QqYuyvcrpynPYZTrGRqD0SBjugCaLvHGDR7e1vzEnnjBJTtuWjXYuXPdsrKIITYKFOacuLqTWXNn85V36UFwor5d1kyqe13RJr_lx1Rd-yxRndPaeHzZ33Inzmwi/s1600-h/0051931_Herceptin.jpg" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;" target="_blank"><img border="0" ps="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjjQSq05nrCsvU-6Ii1QqYuyvcrpynPYZTrGRqD0SBjugCaLvHGDR7e1vzEnnjBJTtuWjXYuXPdsrKIITYKFOacuLqTWXNn85V36UFwor5d1kyqe13RJr_lx1Rd-yxRndPaeHzZ33Inzmwi/s200/0051931_Herceptin.jpg" /></a>Women in this study had already received an average of seven drugs for metastatic disease, including chemotherapy, trastuzumab and lapatinib, prior to receiving T-DM1. No new or unexpected safety signals were observed. The results were presented today at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) from 9 to 13 December 2009 (Abstract #710). [<a href="http://www.posters2view.com/sabcs09/viewp.php?nu=5090" target="_blank">3</a>]<br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">Antibody-drug conjugates or ADCs [<a href="http://www.ncbi.nlm.nih.gov/pubmed/20025606" target="_blank">4</a>] are a unique combination of a precise and targeted monoclonal antibody, a stable linker, and a potent cytotoxic. They have broad utility in basic, preclinical, and clinical applications. [<a href="http://www.ncbi.nlm.nih.gov/pubmed/19894757" target="_blank">5</a>] T-DM1 combines two approaches in one medicine: the anti-cancer activity of the trastuzumab antibody, which blocks signals that make the cancer more aggressive and signals the body’s immune system to destroy the cancerous cells, and the targeted delivery of the potent cytotoxic DM1.<br />
</div><br />
“Breast cancer is the most common cancer among women worldwide with more than one million new cases diagnosed every year and nearly 400,000 deaths, so it is vital that we continue to provide more treatment options” said William M. Burns, CEO of Roche Pharma.<br />
<br />
According to the American Cancer Society [<a href="http://www.cancer.org/downloads/STT/F861009_final%209-08-09.pdf" target="_blank">6</a>], breast cancer is the second leading cause of cancer death in the United States. Women diagnosed with advanced (metastatic) disease have a poor prognosis and only 27% survive five years.<br />
<br />
Approximately 15 to 30% of breast cancers are HER2-positive. [<a href="http://www.ncbi.nlm.nih.gov/pubmed/19707416" target="_blank">7</a>] When HER2-positive breast cancer is advanced, the disease has spread to other parts of the body, most commonly to the lungs, bones, liver and brain. At this stage of the disease, the current goals of existing treatments include symptom relief, tumor shrinkage, improved quality of life and increasing the amount of time women with advanced breast cancer live without the cancer worsening. There are no treatment guidelines or FDA-approved treatment options for women with advanced HER2-positive breast cancer if the disease progresses following treatment with trastuzumab and lapatinib.<br />
<br />
“The much anticipated data on the investigational drug T-DM1 will be welcomed by physicians treating women with early and very advanced stages of breast cancer as it will offer them more choices for fighting this devastating disease,” Burns noted.<br />
<br />
"Despite major advances in HER2-positive breast cancer, the disease may still progress after multiple treatments, to the point where there are no approved HER2-targeted medicines," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. "Results from this study are promising for women who need new treatment options, and we will discuss next steps of the T-DM1 development program with the FDA."<br />
<br />
"These results are significant because they demonstrate that T-DM1 was effective at shrinking tumors in women whose cancer had progressed following prior treatment with standard therapies for HER2-positive breast cancer," said Ian Krop, M.D., Ph.D., a medical oncologist at <a href="http://www.dana-farber.org/" target="_blank">Dana-Farber Cancer Institute</a>, and lead investigator on the study.<br />
<br />
In this single-arm study, 45% of women experienced a clinical benefit (defined as a complete or partial tumor response, or stable disease, maintained for at least six months), as assessed by independent review. Adverse events were similar to those observed in previous clinical trials of T-DM1. The most common severe adverse events included thrombocytopenia (a low level of platelets in the blood, 5.5%) and back pain (3.6%), and the most common adverse events were fatigue (59.1%) and nausea (37.3%). No severe (Grade 3 or higher) cardiac-specific side effects were observed. One patient with pre-existing, non-alcoholic fatty liver disease died with hepatic failure.<br />
<br />
<i>Ongoing clinical trials</i><br />
The new treatment options is currently in trial in a Phase II study, known as TDM4374g, a single-arm, multi-center trial designed to assess T-DM1 as a single agent in 110 women with HER2-positive advanced breast cancer whose disease had progressed after receiving at least two prior HER2-targeted treatments (trastuzumab and lapatinib) in the metastatic setting, as well as an anthracycline, a taxane, and capecitabine. [<a href="http://www.clinicaltrials.gov/ct2/show/NCT00679211" target="_blank">8</a>]<br />
<br />
The primary endpoint of this study is objective response rate (a complete or partial tumor shrinkage of at least 30%, determined by two tumor assessments at least 28 days apart), as measured by an independent review facility. Secondary endpoints include safety, clinical benefit rate, duration of response and progression-free survival (PFS). Duration of response and PFS data are not yet mature and will be presented at a future meeting.<br />
<br />
The results of the data presented during the SABCS follow on from results from another phase II study (TDM4258) presented at ASCO 2009 which also showed encouraging results in women with advanced HER2-positive breast cancer [<a href="http://www.clinicaltrials.gov/ct2/show/NCT00509769" target="_blank">9</a>, <a href="http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=30659" target="_blank">10</a>].<br />
<br />
<i>For more information:</i><br />
[<a href="http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=47&abstractID=35356" target="_blank">1</a>] Beeram M, Krop I, Modi S, Tolcher A, Rabbee N, et al <i>A phase I study of trastuzumab-MCC-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (BC).</i> Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 1042.<br />
[<a href="http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=35721" target="_blank">2</a>] Beeram M, Burris III, HA, Modi S, Birkner M, Girish S, et al. <i>A phase I study of trastuzumab-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with advanced HER2+ breast cancer (BC).</i> J Clin Oncol 26: 2008 (May 20 suppl; abstr 1028).<br />
[<a href="http://www.posters2view.com/sabcs09/viewp.php?nu=5090" target="_blank">3</a>] Krop I, LoRusso P, Miller KD, Modi S, Yardley D, et al. <i>A Phase II Study of Trastuzumab-DM1 (T-DM1), a Novel HER2 Antibody-Drug Conjugate, in Patients Previously Treated with Lapatinib, Trastuzumab, and Chemotherapy.</i> SABCS Poster Session 5: Treatment: Her2-Targeted Therapy (Date/Time: Saturday, December 12, 2009; 5:30 PM-7:30 PM)<br />
[<a href="http://www.ncbi.nlm.nih.gov/pubmed/20025606" target="_blank">4</a>] Teicher BA. <i>Antibody-drug conjugate targets.</i> Curr Cancer Drug Targets. 2009 Dec;9(8):982-1004<br />
[<a href="http://www.ncbi.nlm.nih.gov/pubmed/19894757" target="_blank">5</a>] Hofer T, Skeffington LR, Chapman CM, Rader C. <i>Molecularly defined antibody conjugation through a selenocysteine interface.</i> Biochemistry. 2009 Dec 22;48(50):12047-57.<br />
[<a href="http://www.cancer.org/downloads/STT/F861009_final%209-08-09.pdf" target="_blank">6</a>] American Cancer Society. Breast Cancer Facts & Figures 2009-2010. Atlanta: American Cancer Society, Inc.<br />
[<a href="http://www.ncbi.nlm.nih.gov/pubmed/19707416" target="_blank">7</a>] Murphy CG, Modi S. <i>HER2 breast cancer therapies: a review</i>. Biologics. 2009;3:289-301. Epub 2009 Jul 13.<br />
[<a href="http://www.clinicaltrials.gov/ct2/show/NCT00679211" target="_blank">8</a>] A Study of of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer.<br />
[<a href="http://www.clinicaltrials.gov/ct2/show/NCT00509769" target="_blank">9</a>] A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer.<br />
[<a href="http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=30659" target="_blank">10</a>] Vogel CL, Burris HA, Limentani S, Borson R, O'Shaughnessy J, et al. <i>A phase II study of trastuzumab-DM1 (T-DM1), a HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (MBC): Final results.</i> J Clin Oncol 27:15s, 2009 (suppl; abstr 1017).<br />
<br />
<em>Also:<br />
</em><a href="http://oncozine.ning.com/" target="_blank">Onco’Zine – The International Cancer Network</a><br />
<br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-77179893995602686332009-12-12T17:45:00.002-07:002009-12-15T20:01:13.446-07:00Small, HER2-Positive, Tumors Linked with Poor Prognosis<span style="font-size: large;"><em><strong>Patients with breast cancer whose tumors were HER2-positive and one centimeter or smaller had a significant risk of relapse compared with other tumor types, according to a new study presented at the CRTC-AACR San Antonio Breast Cancer Symposium.</strong></em></span> <br />
<br />
“The current guidelines call for no further therapy if the tumors are less than five millimeters or consider therapy if the tumors are from six to 10 millimeters, but this data challenges that thinking and shows this group of women may benefit from additional therapy,” said Ana M. Gonzalez-Angulo, M.D., assistant professor in the Departments of Breast Medical Oncology and Systems Biology at the <a href="http://www.mdanderson.org/" target="_blank">University of Texas M. D. Anderson Cancer Center</a> (MDACC). <br />
<br />
Gonzalez-Angulo and Ronjay Rakkhit, chief fellow of Hematology-Oncology at M. D. Anderson, and colleagues retrospectively studied 965 patients from MDACC and validated their findings with 350 patients from two European institutions. Patients with a lack of receptor information, and/or who had received adjuvant chemotherapy or <a href="http://www.herceptin.com/" target="_blank">trastuzumab</a> at any time were excluded.<br />
<br />
“This is the largest study of its kind in a patient population, and as our ability to detect tumors improves, this patient population will only continue to increase. Further, it answers a common question oncologist have in daily practice – which early stage patients may be in need of additional therapy,” said AMG. Patients were diagnosed between 1990 and 2003. Median age of the patients at diagnosis was 57 years. All tumors were one centimeter or smaller. Most of the tumors (68%) were hormone receptor-positive, while 10 percent were HER2-positive and 23% were triple receptor-negative. <br />
<br />
Five-year, recurrence-free survival was 77.1% 93.7% in patients with HER2-positive and HER2-negative tumors, respectively, and five-year distant recurrence-free survival was 86.4% and 97.2%, in patients with HER2-positive and HER2-negative tumors, respectively. Patients with HER2-positive tumors had 2.68 times greater risk of recurrence and 5.3 times higher the risk of distant recurrence than those with HER2-negative tumors. <br />
<br />
Patients with HER2-positive tumors had 5.09 times the risk of recurrence and 7.81 times the risk of distant recurrence compared to patients with hormone receptor-positive tumors. <br />
<br />
Data on 350 additional patients treated at two other institutions showed reproducibility, said Gonzalez. “This paper shows that patients with HER2-positive tumors one centimeter or less have a significant risk of relapse and should be considered for clinical trials of systemic anti-HER2 adjuvant therapy, or if a clinical trial is not available, adjuvant therapy should be discussed with them”, said Gonzalez-Angulo.<br />
<br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-59659393922366612772009-12-08T17:30:00.002-07:002009-12-15T21:03:51.720-07:00Eating Pistachios Increases Serum Levels of Gamma-tocopherol, May Help in Reducing Lung Cancer Risk<i><b><span style="font-size: large;">A diet that incorporates a daily dose of pistachios may help reduce the risk of lung and other cancers, according to data presented at the </span><a href="http://www.aacr.org/" target="_blank"><span style="font-size: large;">American Association for Cancer Research</span></a><span style="font-size: large;"> </span><a href="http://www.aacr.org/home/scientists/meetings--workshops/frontiers-in-cancer-prevention-research.aspx" target="_blank"><span style="font-size: large;">Frontiers in Cancer Prevention Research Conference</span></a><span style="font-size: large;">, held Dec. 6-9.</span></b></i><br />
<br />
"It is known that vitamin E provides a degree of protection against certain forms of cancer. Higher intakes of gamma-tocopherol, which is a form of vitamin E, may reduce the risk of lung cancer," said Ladia M. Hernandez, M.S., R.D., L.D., senior research dietitian in the Department of Epidemiology at the University of Texas <a href="http://www.mdanderson.org/" target="_blank">M. D. Anderson Cancer Center</a>, and doctoral candidate at Texas Woman's University - Houston Center.<br />
<br />
"Pistachios are a good source of gamma-tocopherol. Eating them increases intake of gamma-tocopherol so pistachios may help to decrease lung cancer risk," she said.<br />
<br />
Pistachios are known to provide a heart-healthy benefit by producing a cholesterol-lowering effect and providing the antioxidants that are typically found in food products of plant origin. Hernandez and colleagues conducted a six-week, controlled clinical trial to evaluate if the consumption of pistachios would increase dietary intake and serum levels of gamma-tocopherol. A pistachio-rich diet could potentially help reduce the risk of other cancers from developing as well, according to Hernandez.<br />
"Because epidemiologic studies suggest gamma-tocopherol is protective against prostate cancer, pistachio intake may help," she said. "Other food sources that are a rich source of gamma-tocopherol include nuts such as peanuts, pecans, walnuts, soybean and corn oils."<br />
<br />
The study, conducted at Texas Woman's University - Houston Center, included 36 healthy participants who were randomized into either a control group or the intervention group consisting of a pistachio diet. There were 18 participants in the control group and 18 in the intervention group.<br />
There was a two-week baseline period, followed by a four-week intervention period in which the intervention group was provided with 68 grams (about 2 ounces or 117 kernels) of pistachios per day; the control group continued with their normal diet.<br />
<br />
The effect on the intake and serum cholesterol-adjusted gamma-tocopherol was investigated. Intake was calculated using the Nutrition Data System for Research Version 2007, and consumption was monitored using diet diaries and by measuring the weights of the returned pistachios.<br />
Hernandez and colleagues found a significant increase in energy-adjusted dietary intake of gamma-tocopherol at weeks three and four in those on the pistachio diet compared with those on the control diet. The similar effect was seen at weeks five and six among those on the pistachio diet compared with those on the control diet. For those on the pistachio diet, cholesterol-adjusted serum gamma-tocopherol was significantly higher at the end of the intervention period compared to baseline.<br />
<br />
"Pistachios are one of those ‘good-for-you' nuts, and 2 ounces per day could be incorporated into dietary strategies designed to reduce the risk of lung cancer without significant changes in body mass index," said Hernandez.<br />
<br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-592219232364360792009-12-06T21:23:00.004-07:002009-12-06T21:41:59.707-07:00Targeted Breast Ultrasound Can Reduce Biopsies for Women under Forty<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><i><span style="font-size: large;"><b>Targeted breast ultrasound of suspicious areas of the breast, including lumps, is a safe, reliable and cost-effective alternative to invasive biopsies for women under age 40, according to the findings of two studies presented at the 95th Scientific Assembly and Annual Meeting of the <a href="http://rsna2009.rsna.org/" target="_blank">Radiological Society of North America (RSNA)</a>.</b><br />
</span></i><br />
</div><br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">"By performing high-quality breast ultrasound, we can reduce the number of expensive and avoidable invasive diagnostic procedures in young women," said senior author Constance D. Lehman, M.D., Ph.D., professor and vice chair of radiology at the University of Washington and director of imaging at the Seattle Cancer Care Alliance. "We don’t want to be overly aggressive with this population."<br />
</div><br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">The researchers conducted two studies in which targeted ultrasound was used to distinguish between potentially cancerous masses and benign findings in young women who had detected breast lumps or other focal (specific) areas of concern in their breasts. The first study included 1,123 ultrasound examinations of women under age 30, while the second included 1,577 ultrasound examinations of women ages 30 to 39.<br />
</div><br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">Across both studies, all instances of cancer at the site of the clinical concern were positively identified through targeted ultrasound. In addition, all negative ultrasound findings correctly identified benign changes in the breast. The only malignant mass not identified by ultrasound was an unsuspected lesion outside of the targeted examination area. That cancer was identified by a full breast mammogram.<br />
</div><br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhftBF83Kx8c809ygww8zu7zOi4u4fJrEs-bIPinNQYOWOCIIp1KP_utJTrHgjq2ll3KI0NZCoj61VqPoYwjQXEbeGmOpKCVaqpsWkFTkUQkyz7mtXVwH75Ua74HxmIyeVjxCbeBt8bHHzJ/s1600-h/US-probably-benign-mass-1.jpg" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" er="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhftBF83Kx8c809ygww8zu7zOi4u4fJrEs-bIPinNQYOWOCIIp1KP_utJTrHgjq2ll3KI0NZCoj61VqPoYwjQXEbeGmOpKCVaqpsWkFTkUQkyz7mtXVwH75Ua74HxmIyeVjxCbeBt8bHHzJ/s200/US-probably-benign-mass-1.jpg" /></a>The incidence of malignancy among women in their 30s was 2%. The incidence of malignancy among women younger than 30 was 0.4 percent.<br />
<br />
<span style="font-size: x-small;"></span><span style="font-size: x-small;"><em><strong>Fig 1.</strong> A breast ultrasound image showing a benign mass.<span style="font-size: x-small;"></span></em></span><br />
<br />
"Surgical excision or needle biopsy of tissue can be painful, expensive and frequently unnecessary in these age groups, which have very low rates of malignancies," Dr. Lehman said. "In most cases, monitoring with targeted ultrasound is a very safe alternative."<br />
<br />
She added that ultrasound should be the diagnostic tool of choice for young women seeking care for breast lumps and other suspicious focal signs and symptoms. "It is time we used ultrasound to reduce unnecessary morbidity and costs associated with more aggressive invasive approaches," Dr. Lehman said.<br />
<br />
<i>Also see Abstracts:</i><br />
- <a href="http://rsna2009.rsna.org/search/event_display.cfm?em_id=8001788&printmode=y&autoprint=n" target="_blank">Outcomes of Targeted Ultrasound Evaluation in Women Under 30 Years of Age with Focal Breast Signs or Symptoms.</a> Presented by Dr. Vilert Loving, MD<br />
- <a href="http://rsna2009.rsna.org/search/event_display.cfm?em_id=8001966&printmode=y&autoprint=n">Contribution of Mammography to Ultrasound Evaluation of Women 30 to 39 Years of Age with Focal Breast Signs or Symptoms .</a> Presented by Michael Portillo, MD<br />
<br />
<em>For more information:</em><br />
- <a href="http://oncozine.ning.com/" target="_blank">Onco'Zine - The International Cancer Network</a><br />
<br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><br />
</div><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-20340273175913394632009-12-06T19:20:00.000-07:002009-12-06T19:20:21.451-07:00Ultrasound with Elastography May Improve Skin Cancer Detection<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><strong><em><span style="font-size: large;">High-frequency ultrasound with elastography can help differentiate between cancerous and benign skin conditions, according to a study presented at the 95th Scientific Assembly and <a href="http://rsna2009.rsna.org/" target="_blank">Annual Meeting of the Radiological Society of North America (RSNA).</a></span></em></strong><br />
</div><br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">"High-frequency ultrasound with elastography has the potential to improve the efficiency of skin cancer diagnosis," said lead author Eliot L. Siegel, M.D., vice chairman of the Department of Radiology at the University of Maryland School of Medicine (UMSM) in Baltimore. "It successfully delineated the extent of lesions and was able to provide measurable differentiation among a variety of benign and malignant lesions."<br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div>There are more than one million cases of skin cancer diagnosed in the U.S. every year, according to the American Cancer Society. Melanoma, the most serious type of skin cancer, will account for about 68,720 cases of skin cancer and 11,590 deaths in 2009, despite the fact that with early detection it is highly curable.<br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">Suspicious skin lesions are typically diagnosed by dermatologists and biopsied based on their surface appearance and characteristics. Unfortunately, even to experienced dermatologists, benign and malignant lesions often appear similar visually and on physical examination, and some malignant lesions may have a benign appearance, especially in their early stages. It is not uncommon for patients to have one or more lesions that appear concerning.<br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">"Dermatologists tend to biopsy any lesions that seem visually suspicious for disease," said coauthor Bahar Dasgeb, M.D., from the Department of Dermatology at Wayne State University in Detroit and Pinkus Dermatopathology Lab in Monroe, Michigan. "Consequently, many benign lesions are needlessly biopsied in order to avoid the risk of missing a potentially deadly melanoma." <br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">Elastography was found to distinguish between benign and malignant lesions not by their visible appearance but by measuring their elasticity or stiffness. Since malignancies are stiffer than benign growths, elastography, when added to high-frequency ultrasound imaging of the skin, has potential to improve the accuracy of traditional clinical diagnosis of skin cancers and, in some cases, eliminate unnecessary biopsies of benign skin lesions. The procedure is noninvasive, convenient and inexpensive.<br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhW4HvcZmw0bclx-89dDCcZBF9oTH7dt78k-bK_hg_NEFvr-WFU3WzdvP847X9ZeiixAYzXk-mdVRBOYAfaO44O4iK_s2QHZHPF11LHoBrgzXFcMgTJ_Zc49-i3vVE8mFBVp1VCiqQ4ggb3/s1600-h/Skin-Cancer-Elastography-and-Ultrasound-2.jpg" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" er="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhW4HvcZmw0bclx-89dDCcZBF9oTH7dt78k-bK_hg_NEFvr-WFU3WzdvP847X9ZeiixAYzXk-mdVRBOYAfaO44O4iK_s2QHZHPF11LHoBrgzXFcMgTJ_Zc49-i3vVE8mFBVp1VCiqQ4ggb3/s200/Skin-Cancer-Elastography-and-Ultrasound-2.jpg" /></a>For the study, researchers used an ultra high-frequency ultrasound system to image 40 patients with a variety of malignant and nonmalignant, or benign, skin lesions. Malignant tumors included squamous cell carcinoma, basal cell carcinoma and melanoma. Benign lesions included dermatofibroma, a noncancerous growth containing scar tissue, and lipoma, a noncancerous tumor composed of fatty tissue.<br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br />
</div><em><span style="font-size: x-small;"><strong>Fig 1.</strong> An elastogram (left) and ultrasound (right) showing squamous cell carcinoma of the skin.</span></em><br />
<br />
<br />
The researchers calculated the ratio of elasticity between normal skin and the adjacent skin lesion, and used laboratory analysis to confirm their diagnoses. Cystic lesions, which are not malignant, demonstrated high levels of elasticity, while malignant lesions were significantly less elastic. The elasticity ratio of normal skin to the various skin lesions ranged from 0.04 to 0.3 for cystic skin lesions to above 10.0 for malignant lesions.<br />
<br />
In addition, high-frequency ultrasound with elastography allows for accurate characterization of the extent and depth of the lesion below the surface, which can aid physicians in treatment.<br />
<br />
<br />
<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjxVNg2ogt2fUiAtjR0sAye17wreCBC52TgkPNo82D8xg1qfVtoayxP0s5ZOKDwKMh5fzInY9AGtDDEFjqK06ah-j95m5fYfqg-pyc8eZYt6hyxOkruVsOg_i2qvbmRjE8iozddMuZ2LqbM/s1600-h/Premalignant-Lesion-Elastography-and-Ultrasound.jpg" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" er="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjxVNg2ogt2fUiAtjR0sAye17wreCBC52TgkPNo82D8xg1qfVtoayxP0s5ZOKDwKMh5fzInY9AGtDDEFjqK06ah-j95m5fYfqg-pyc8eZYt6hyxOkruVsOg_i2qvbmRjE8iozddMuZ2LqbM/s200/Premalignant-Lesion-Elastography-and-Ultrasound.jpg" /></a><br />
</div>"The visualized portion of a skin lesion can be just the tip of the iceberg, and most dermatologists operate 'blindly' beyond what they can see on the surface," Dr. Siegel said. "High-frequency ultrasound provides almost microscopic resolution and enables us to get size, shape and extent of the lesion prior to biopsy."<br />
<br />
<br />
<span style="font-size: x-small;"><strong>Fig 2.</strong> An elastogram (left) and ultrasound image (right) showing a premalignant lesion<br />
</span><br />
<br />
<em>For more information, also see:</em><br />
<a href="http://rsna2009.rsna.org/search/event_display.cfm?em_id=8009893&printmode=y&autoprint=n" target="_blank">Elastographic Ultrasound Quantitative Analysis Combined with High Frequency Imaging for Characterization of Benign and Malignant Skin Lesions</a> Presented by Dr. Bahar Dasgeb, MD.<br />
<br />
<em>Also see:</em><br />
<a href="http://oncozine.ning.com/profiles/blogs/ultrasound-with-elastography" target="_blank">Ultrasound with Elastography May Improve Skin Cancer Detection</a><br />
<br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-55394454386430056032009-12-06T18:57:00.005-07:002009-12-06T19:05:02.083-07:00Annual Screening with Breast Ultrasound or MRI Could Benefit Some Women<span style="font-size: large;"><em><strong>Results of a large-scale clinical trial presented presented at the 95th Scientific Assembly and Annual Meeting of the <a href="http://rsna2009.rsna.org/preliminary_information.cfm" target="_blank">Radiological Society of North America (RSNA)</a> provide the first strong evidence of the benefit of annual screening ultrasound for women with dense breasts who are at elevated risk for breast cancer. In addition, the study confirmed that MRI is highly sensitive in depicting early breast cancer.</strong></em></span><br />
<br />
"We found that annual screening with ultrasound in addition to mammography significantly improves the detection of early breast cancer," said lead researcher Wendie A. Berg, M.D., Ph.D., breast imaging specialist at American Radiology Services, Johns Hopkins — Green Spring Station in Lutherville, Md., "and that significantly more early breast cancer can be found when MRI is performed, even after combined screening with both ultrasound and mammography. However, both ultrasound and MRI increase the risk of false-positive findings."<br />
<br />
<div class="separator" style="clear: both; text-align: left;">Women who are at high risk for breast cancer need to begin screening at a younger age, because they often develop cancer earlier than women at average risk. However, women below age 50 are more likely to have dense breast tissue, which can limit the effectiveness of mammography as a screening tool.<br />
</div><br />
Multicenter trials have shown that MRI enables radiologists to accurately identify tumors missed by mammography and ultrasound. The American Cancer Society recommends that some groups of women with a high risk of developing breast cancer should be screened with MRI in addition to their yearly mammogram beginning at age 30. However, MRI is not for everyone.<br />
<br />
<div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">"Because MRI is a very expensive test and requires intravenous contrast, it is something we only recommend for screening the approximately 2% of women who are known or likely carriers of BRCA1 or BRCA2 gene mutations or have other unusual circumstances that put them at very high risk for breast cancer," Dr. Berg said.<br />
<br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVoZGqejlzSXZrmDp4CIudxdahNTLBh3weAo-UIPxs6vxRA03Wh9HsLsoXAomAcKmHUB9Q8myI9Eh3AtTm-48wZ2sHvNSEsPaA6UP-INNN4Gw6Mzr_7hY_VYE2J6eBa_QpThK5u5hF1vZ2/s1600-h/Breast-MRI_2009_1_RSNA.jpg" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" er="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVoZGqejlzSXZrmDp4CIudxdahNTLBh3weAo-UIPxs6vxRA03Wh9HsLsoXAomAcKmHUB9Q8myI9Eh3AtTm-48wZ2sHvNSEsPaA6UP-INNN4Gw6Mzr_7hY_VYE2J6eBa_QpThK5u5hF1vZ2/s200/Breast-MRI_2009_1_RSNA.jpg" /></a><br />
</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">"There are another 10 to 15% of women who are at some increased risk because of personal history of breast cancer, family history of breast cancer and/or dense breast tissue," she added. "For many of these women, MRI is not currently justified, but annual ultrasound would be appropriate in addition to mammography."<br />
</div><br />
<em><strong>Fig 1.</strong> This breast MRI showing focus of enhancement in left breast, negative on mammography and screening ultrasound. Pathology proven infiltrating ductal carcinoma</em><br />
<br />
The researchers studied 612 women, mean age 55 years, at elevated risk of breast cancer enrolled at 14 sites in the American College of Radiology Imaging Network (ACRIN) 6666 trial funded by the Avon Foundation and the National Cancer Institute. Women underwent baseline screening mammography and ultrasound with follow-up exams at 12 and 24 months and then a single, contrast-enhanced MRI at 24 months.<br />
<br />
<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihQpD2zDqhhCw_DEJlSVv8JFdfbpaW8F1_CUEkc98FyeAKUZ4iCeW2HSo_ZB4g_qPlSGMWGYc-Oxoh-Vn7wPC2OjGcBzWVoEIhH4AOiFUyySKnmNx3uyGctAnpgykHoZWIaEd4qxa8XsgX/s1600-h/Breast-ultrasound.jpg" imageanchor="1" style="clear: left; cssfloat: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" er="true" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihQpD2zDqhhCw_DEJlSVv8JFdfbpaW8F1_CUEkc98FyeAKUZ4iCeW2HSo_ZB4g_qPlSGMWGYc-Oxoh-Vn7wPC2OjGcBzWVoEIhH4AOiFUyySKnmNx3uyGctAnpgykHoZWIaEd4qxa8XsgX/s200/Breast-ultrasound.jpg" /></a><br />
</div>Sixteen women were diagnosed with breast cancer. Twelve of the cancers were invasive, and four were ductal carcinoma in situ (DCIS). Over the course of the study, 50 to 56 percent of cancers were shown on mammography. Adding ultrasound allowed detection of 70 to 94% of cancers. Adding MRI allowed for detection of additional cancers at their earliest stage.<br />
<br />
<em><strong>Fig 2.</strong> Ultrasound showing 9-mm benign mass (arrows) in upper inner quadrant</em><br />
<br />
The study also found that supplemental screening with ultrasound or MRI significantly increased the risk of false-positive findings, leading to unnecessary biopsies in some women.<br />
<br />
"It is important that women are advised of the increased potential of undergoing an unnecessary biopsy as a result of screening with ultrasound or MRI," Dr. Berg said, "but we hope this study motivates women and their doctors to learn more about their risk factors and to consider supplemental screening in addition to mammography where indicated."<br />
<br />
<em>Also see Abstracts:</em> <br />
<a href="http://rsna2009.rsna.org/search/event_display.cfm?em_id=8002965&printmode=y&autoprint=n" target="_blank">Supplemental Yield and Performance Characteristics of Screening MRI after Combined Ultrasound and Mammography: ACRIN* 6666 *American College of Radiology Imaging Network.</a><br />
<br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0tag:blogger.com,1999:blog-5162684219865162218.post-53356723814536058142009-12-06T18:02:00.002-07:002009-12-06T18:34:54.587-07:00Bisplatinates, a New Class of Platinum-Based Anti-Tumor Drugs, Demonstrates Potent Anti-Tumor Activity and Ability to Overcome Resistance to Currently Available Platinum-Based Agents<em><strong><span style="font-size: large;">Seattle-based </span></strong></em><a href="http://www.celltherapeutics.com/" target="_blank"><em><strong><span style="font-size: large;">Cell Therapeutics, Inc</span></strong></em></a><span style="font-size: large;"><em><strong>, a biopharmaceutical company committed to developing an integrated portfolio of oncology products, today announced that its new class of platinum-based anti-tumor compounds, termed bis-platinates, demonstrated a stronger anti-tumor potency and activity compared to currently available platinum-based compounds as well as the ability to overcome cisplatin-resistance in cancer cell lines.</strong></em> </span><br />
<br />
The results were presented in a paper titled "Novel Bis-platinum Complexes Endowed with an Improved Pharmacological Profile," by Laura Gatti et al. that was published in the online edition of the journal Molecular Pharmaceutics. Platinum-based compounds, such as cisplatin and oxaliplatin, are the cornerstone in the treatment of testicular, ovarian, colorectal, lung and other cancers but their effectiveness is limited by the relatively low therapeutic ratio, the ratio of the maximally tolerated dose of the drug to the effective dose, and the frequent occurrence of drug resistance leading to cancer recurrence. The novel bis-platinum compounds represent a completely new class of platinum-based drugs called bisplatinates.<br />
<br />
The bis-platinum based compounds, unlike the currently approved platinum-based compounds, contain two platinum atoms and work by binding to and damaging both strands of DNA making it much more difficult for cancer cells to repair the damage. The research demonstrated through cancer cell assays and animal tumor models that the bis-platinum complexes exhibited greater cytotoxic potency and anti-tumor effect compared to <a href="http://www.bedfordlabs.com/products/inserts/CIS-AQ-P01.pdf" target="_blank">cisplatin</a> and <a href="http://www.sanofi-aventis.ca/products/en/eloxatin.pdf" target="_blank">oxaliplatin</a>.<br />
<br />
There was more than a 200-fold increase in percent accumulation in tumor cells of the bisplatinum compounds compared to cisplatin and oxaliplatin. The bisplatinates were substantially more active against human tumors grown in an immunodeficient preclinical model than the standard palatinate compounds, oxaliplatin, carboplatin and cisplatin. Furthermore, the bis-platinum compounds demonstrated the ability to overcome tumor resistance to cisplatin mediated by DNA mismatch repair defects. The complexes showed marked anti-tumor efficacy in platinum refractory tumors, with significant activity in terms of tumor growth inhibition and tumor growth delay.<br />
<br />
"Platinum-based compounds are cornerstone agents in the treatment of very common cancers such as cancers of the lung, colon, and ovary and are also widely used in other gynecological-tumors, testicular cancers, and cancers of the esophagus, head and neck. They are increasingly being used for salvage therapy in lymphoma. However, resistance to palatinate compounds is common. The current results are encouraging as they demonstrate that the bisplatinates are not only more effective in human tumor models than the current agents, but also capable of overcoming some forms of palatinate resistance," said Jack Singer, M.D., Chief Medical Officer of CTI.<br />
<br />
<em>For more information:</em><br />
Gatti L, Perego P, Leone R, Apostoli P, Carenini N, et al. <a href="http://www.ncbi.nlm.nih.gov/pubmed/19919086" target="_blank">Novel Bis-platinum Complexes Endowed with an Improved Pharmacological Profile</a>. Mol Pharm. 2009 Nov 17. [Epub ahead of print]<br />
<br />
<em>Also see:</em><br />
<a href="http://oncozine.ning.com/profiles/blogs/ultrasound-with-elastography" target="_blank">Bisplatinates, a New Class of Platinum-Based Anti-Tumor Drugs, Demonstrates Potent Anti-Tumor Activity</a><br />
<br />
<img border="0" src="http://www.blogburst.com/Resources/Images/blogburst_80x15.gif?id=B8tbhcuqYXb9C0x9HQ3Wrdj" /><div class="blogger-post-footer">Copyright © 2009 - 2010 Sunvalley Communication. All rights reserved.
Republication or redistribution of this content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.</div>Standplaats: Amerika/Peter Hofland, PhDhttp://www.blogger.com/profile/01716715730830298689noreply@blogger.com0