“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.
“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.
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.
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.
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.
More Information:
Visit Onco'Zine The International Cancer Network for an overview of the daily news from ESMO 2010 conference.
Showing posts with label research. Show all posts
Showing posts with label research. Show all posts
Tuesday, October 12, 2010
Saturday, December 12, 2009
Final Follow-Up of Z-FAST Study Shows Zoledronic Acid May Benefit Postmenopausal Woman with Aromatase Inhibitor-Associated Bone Loss
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 San Antonio Breast Cancer Symposium.
"Women who take aromatase inhibitors need some sort of bone protection, and this five-year data show that zoledronic acid 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, University of Pittsburgh Cancer Institute.
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 Arimidex by AstraZeneca, is scheduled to go off patent within the next few years.
"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.
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.
Brufsky's study, Z-FAST (Zometa-Femara Adjuvant Synergy Trial), 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.
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.
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.
For more information:
"Women who take aromatase inhibitors need some sort of bone protection, and this five-year data show that zoledronic acid 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, University of Pittsburgh Cancer Institute.
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 Arimidex by AstraZeneca, is scheduled to go off patent within the next few years.
"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.
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.
Brufsky's study, Z-FAST (Zometa-Femara Adjuvant Synergy Trial), 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.
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.
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.
For more information:
Saturday, October 3, 2009
New Cancer Research Priorities Needed to Correct Imbalance that Leaves Important Questions Neglected
Cancer research is too focused on new drug development, while not enough money and effort is being devoted to pursuing important advances in knowledge likely to have the biggest impact on combating the disease in the next few decades, a leading research policy expert says, adding that a major shift in research priorities will be crucial to the ability to cope with the coming wave of cancer cases.
Professor Richard Sullivan of the King’s Health Partners Integrated Cancer Centre in London told Europe’s largest cancer congress, ECCO 15 – ESMO 34, the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress, September 20 – 24 in Berlin, Germany, that studies aiming to improve surgery, pathology and diagnostic and staging imaging, as well as a radical rethink of the approach to prevention research, must become the focus of public- and federally-funded cancer research now. The global public sector spend on cancer research was about €14 billion a year in 2004/05, the latest year for which figures are available. Non-commercial funders in Europe spent just over €3 billion on cancer research in 2004/05.
“An analysis we have just completed shows that, on average, European public funders are spending 74% of their money on fundamental biology and drug development research and that well over 70% of the cancer research initiatives at the European level are aimed at the same areas,” noted Prof Sullivan, who is also chairman of the European Cancer Research Managers Forum, which studies cancer research and funding in Europe.
“In the United States, the imbalance is even greater. There is no shortage of cancer drugs coming through pipeline and the whole area of drug research is quite healthy. What we need is a reapportioning of budgets from the charitable sector and public funders to carve out space for these other areas of cancer research that are largely invisible to a lot of policymakers."
“This is a deeply unfashionable view and the easy way out is to say that we must just ask for more money, but the reality is that we’ve got to prioritise,” Prof Sullivan said. “Most of the new medicines are having a small impact on the big picture of cancer burden at the moment, extending life by a few months. Research in this area is already heavily funded and that will continue regardless, as will the investments in fundamental cancer biology.”
The World Health Organization predicts that the number of people worldwide living with cancer will rise from about 28 million today to about 75 million in 2030. Detecting cancer early enough to treat it successfully and improving our understanding of how to make primary prevention strategies work hold the potential for the greatest gains, he said.
“This demands an overhaul of prevention research. You can take the quite reasonable view that we know the risk factors now. What we don’t understand is how to take that research on prevention and apply it in populations because we don’t understand the behaviour of those groups or how that might change over the next 20 or 30 years. For instance, how do we address the fact that many men across Europe will put up with rectal bleeding for a year before going to see a doctor? This is very important because cancer is not just about genes, it is predominantly about culture.”
"Cancer researchers must now be more imaginative and collaborate across unusual disciplinary boundaries to embrace behavioural engineering, population psychology, evolutionary biology, novel sociological methods and ideas such as cultural transmission theory – the study of how behaviours are learned and transmitted between generations," Sullivan explained
“Research in these novel areas addresses questions that can never be answered with classical epidemiological studies or standard social science questionnaires – we’ve reached the limits of enquiry with many standard approaches. There are people doing fantastic work that could be extremely useful not only to cancer research, but to medicine in general and most medics and researchers are completely ignorant about their existence and what they can do for medicine. It is a huge untapped area with massive potential to make a difference,” Prof Sullivan said.
The growing scale of cancer in developing countries also presents an imminent challenge for cancer research, he said. More than half of all cancer diagnoses occur in developing countries, which will bear a large majority of the global burden before long. Keeping the research focus as it is in developed countries will not address the problem in the developing and transitional countries because drug development is not going to be the answer. Surgery and radiotherapy are the most important approaches for reducing the global cancer burden and financial support for programmes that bring those treatments to developing countries is still very poor.
“The argument is always made that there is enough to deal with in developing countries with the infectious disease challenges, but chronic disease is a major, often unrecognised problem and we can’t afford to wait any longer. Like it or not, developed countries have a responsibility to investigate which cancer control approaches are exportable and to support those institutions working in these areas,” he said.
Governments, research charities and European funders need to recognise the importance of shifting the focus to a new approach to prevention research and more investment in non-drug treatment research, but it will be largely up to cancer researchers to drive the change, Prof Sullivan said.
“There has already recently been a major shift in Europe toward hospital-university alliances driving the agenda. They need to start banging on the doors of the non-government organisations and the federal funders, lobbying hard and proving that it’s important to give attention to these neglected areas of cancer research.”
For more information:
Professor Richard Sullivan of the King’s Health Partners Integrated Cancer Centre in London told Europe’s largest cancer congress, ECCO 15 – ESMO 34, the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress, September 20 – 24 in Berlin, Germany, that studies aiming to improve surgery, pathology and diagnostic and staging imaging, as well as a radical rethink of the approach to prevention research, must become the focus of public- and federally-funded cancer research now. The global public sector spend on cancer research was about €14 billion a year in 2004/05, the latest year for which figures are available. Non-commercial funders in Europe spent just over €3 billion on cancer research in 2004/05.“An analysis we have just completed shows that, on average, European public funders are spending 74% of their money on fundamental biology and drug development research and that well over 70% of the cancer research initiatives at the European level are aimed at the same areas,” noted Prof Sullivan, who is also chairman of the European Cancer Research Managers Forum, which studies cancer research and funding in Europe.
“In the United States, the imbalance is even greater. There is no shortage of cancer drugs coming through pipeline and the whole area of drug research is quite healthy. What we need is a reapportioning of budgets from the charitable sector and public funders to carve out space for these other areas of cancer research that are largely invisible to a lot of policymakers."
“This is a deeply unfashionable view and the easy way out is to say that we must just ask for more money, but the reality is that we’ve got to prioritise,” Prof Sullivan said. “Most of the new medicines are having a small impact on the big picture of cancer burden at the moment, extending life by a few months. Research in this area is already heavily funded and that will continue regardless, as will the investments in fundamental cancer biology.”
The World Health Organization predicts that the number of people worldwide living with cancer will rise from about 28 million today to about 75 million in 2030. Detecting cancer early enough to treat it successfully and improving our understanding of how to make primary prevention strategies work hold the potential for the greatest gains, he said.
“This demands an overhaul of prevention research. You can take the quite reasonable view that we know the risk factors now. What we don’t understand is how to take that research on prevention and apply it in populations because we don’t understand the behaviour of those groups or how that might change over the next 20 or 30 years. For instance, how do we address the fact that many men across Europe will put up with rectal bleeding for a year before going to see a doctor? This is very important because cancer is not just about genes, it is predominantly about culture.”
"Cancer researchers must now be more imaginative and collaborate across unusual disciplinary boundaries to embrace behavioural engineering, population psychology, evolutionary biology, novel sociological methods and ideas such as cultural transmission theory – the study of how behaviours are learned and transmitted between generations," Sullivan explained
“Research in these novel areas addresses questions that can never be answered with classical epidemiological studies or standard social science questionnaires – we’ve reached the limits of enquiry with many standard approaches. There are people doing fantastic work that could be extremely useful not only to cancer research, but to medicine in general and most medics and researchers are completely ignorant about their existence and what they can do for medicine. It is a huge untapped area with massive potential to make a difference,” Prof Sullivan said.
The growing scale of cancer in developing countries also presents an imminent challenge for cancer research, he said. More than half of all cancer diagnoses occur in developing countries, which will bear a large majority of the global burden before long. Keeping the research focus as it is in developed countries will not address the problem in the developing and transitional countries because drug development is not going to be the answer. Surgery and radiotherapy are the most important approaches for reducing the global cancer burden and financial support for programmes that bring those treatments to developing countries is still very poor.
“The argument is always made that there is enough to deal with in developing countries with the infectious disease challenges, but chronic disease is a major, often unrecognised problem and we can’t afford to wait any longer. Like it or not, developed countries have a responsibility to investigate which cancer control approaches are exportable and to support those institutions working in these areas,” he said.
Governments, research charities and European funders need to recognise the importance of shifting the focus to a new approach to prevention research and more investment in non-drug treatment research, but it will be largely up to cancer researchers to drive the change, Prof Sullivan said.
“There has already recently been a major shift in Europe toward hospital-university alliances driving the agenda. They need to start banging on the doors of the non-government organisations and the federal funders, lobbying hard and proving that it’s important to give attention to these neglected areas of cancer research.”
For more information:
Monday, August 31, 2009
New Assessment Quantifies Risks and Benefits of Warfarin Treatment for Atrial Fibrillation
Warfarin (an oral anticoagulant) therapy for patients with atrial fibrillation - the most common type of significant heart rhythm disorder - appears to be most beneficial for the oldest patients, for those who have had a prior stroke and for patients with multiple risk factors for stroke, according to a new study by Kaiser Permanente and Massachusetts General Hospital researchers.
This comparative effectiveness research study, among the first and largest to quantify warfarin's net clinical benefit - how much a treatment's potential benefits outweigh its risks - in the usual clinical care of patients with atrial fibrillation, appears in the September 1 issue of The Annals of Internal Medicine.
As part of the ongoing ATRIA (AnTicoagulation and Risk Factors In Atrial Fibrillation) study, researchers followed 13,559 adults with atrial fibrillation treated within Kaiser Permanente of Northern California from 1996 to 2003. To evaluate the risks and benefits of warfarin treatment and give patients and physicians quantitative guidance in making therapeutic decisions, the researchers analyzed rates of the two most significant adverse events associated with warfarin therapy - ischemic stroke, the type produced by arterial blockage, and intracranial hemorrhage, bleeding within and around the brain. In patients who did and did not take warfarin, the investigators balanced the reduction in ischemic stroke attributable to treatment against the increase in intracranial bleeding associated with warfarin. Since intracranial hemorrhages usually have worse outcomes than ischemic strokes, bleeding events were given greater weight in the comparison.
While warfarin therapy benefited most atrial fibrillation patients, the balance of benefits over risks was greatest in those at highest risk of stroke - those with multiple risk factors, those with a history of stroke and the oldest patients. The benefits of treatment increased dramatically with age, with no clear benefit in the average patient younger than 65 but a reduction of more than two strokes per 100 patients in those 85 and older.
Occurring when the upper chambers of the heart quiver instead of contract smoothly, atrial fibrillation affects more than 2.3 million Americans. Because the heart rhythm disturbance promotes the formation of blood clots, which can travel to the brain and block an artery, atrial fibrillation increases the risk of stroke fivefold. The condition is highly age-dependent and affects 10 percent of those over age 80.
Researchers have long known that warfarin is effective in preventing such strokes, but the treatment can be difficult to control and often leads to hemorrhages. In fact, warfarin is associated with the most emergency admissions for drug-related adverse reactions, according to the researchers. Balancing the benefits of warfarin against its most severe risks is critical to making the best therapeutic decisions for individual atrial fibrillation patients, explains the study's senior author Alan S. Go, MD, Director of the Comprehensive Clinical Research Unit at the Kaiser Permanente Division of Research in Oakland, CA
Daniel Singer, MD, of the Massachusetts General Hospital Clinical Epidemiology Unit, the report's lead author, adds, "This comparative effectiveness study gives us more information about which atrial fibrillation patients are most likely to benefit from carefully administered warfarin therapy." He explains that, by assessing warfarin within a "real world" practice setting, the study provides a more contemporary assessment of the therapy's overall effects than do older clinical studies.
Go explains that Kaiser Permanente physicians in Northern California partner with pharmacist-run anticoagulation clinics to provide thorough and nimble administration and careful monitoring of warfarin therapy for atrial fibrillation patients. This allows for delivery of high-quality anticoagulation therapy through frequent testing and appropriate dose adjustment to account for changes in diet, medications and clinical status that may impact the therapy's narrow therapeutic window.
Singer adds, "One of our distinctive findings is that stroke risk continues to increase in patients age 85 and older and that warfarin provides substantial net protection for these elderly patients. A caution is that all these patients were presumably judged by their physicians to be reasonable candidates for warfarin therapy, so these results do not automatically apply to all elderly atrial fibrillation patients."
Funding for the study was provided by the National Institute on Aging, the National Heart, Lung. Blood Institute and the Eliot B. and Edith C. Shoolman fund of the Massachusetts General Hospital.
This comparative effectiveness research study, among the first and largest to quantify warfarin's net clinical benefit - how much a treatment's potential benefits outweigh its risks - in the usual clinical care of patients with atrial fibrillation, appears in the September 1 issue of The Annals of Internal Medicine.
As part of the ongoing ATRIA (AnTicoagulation and Risk Factors In Atrial Fibrillation) study, researchers followed 13,559 adults with atrial fibrillation treated within Kaiser Permanente of Northern California from 1996 to 2003. To evaluate the risks and benefits of warfarin treatment and give patients and physicians quantitative guidance in making therapeutic decisions, the researchers analyzed rates of the two most significant adverse events associated with warfarin therapy - ischemic stroke, the type produced by arterial blockage, and intracranial hemorrhage, bleeding within and around the brain. In patients who did and did not take warfarin, the investigators balanced the reduction in ischemic stroke attributable to treatment against the increase in intracranial bleeding associated with warfarin. Since intracranial hemorrhages usually have worse outcomes than ischemic strokes, bleeding events were given greater weight in the comparison.
While warfarin therapy benefited most atrial fibrillation patients, the balance of benefits over risks was greatest in those at highest risk of stroke - those with multiple risk factors, those with a history of stroke and the oldest patients. The benefits of treatment increased dramatically with age, with no clear benefit in the average patient younger than 65 but a reduction of more than two strokes per 100 patients in those 85 and older.
Occurring when the upper chambers of the heart quiver instead of contract smoothly, atrial fibrillation affects more than 2.3 million Americans. Because the heart rhythm disturbance promotes the formation of blood clots, which can travel to the brain and block an artery, atrial fibrillation increases the risk of stroke fivefold. The condition is highly age-dependent and affects 10 percent of those over age 80.
Researchers have long known that warfarin is effective in preventing such strokes, but the treatment can be difficult to control and often leads to hemorrhages. In fact, warfarin is associated with the most emergency admissions for drug-related adverse reactions, according to the researchers. Balancing the benefits of warfarin against its most severe risks is critical to making the best therapeutic decisions for individual atrial fibrillation patients, explains the study's senior author Alan S. Go, MD, Director of the Comprehensive Clinical Research Unit at the Kaiser Permanente Division of Research in Oakland, CA
Daniel Singer, MD, of the Massachusetts General Hospital Clinical Epidemiology Unit, the report's lead author, adds, "This comparative effectiveness study gives us more information about which atrial fibrillation patients are most likely to benefit from carefully administered warfarin therapy." He explains that, by assessing warfarin within a "real world" practice setting, the study provides a more contemporary assessment of the therapy's overall effects than do older clinical studies.
Go explains that Kaiser Permanente physicians in Northern California partner with pharmacist-run anticoagulation clinics to provide thorough and nimble administration and careful monitoring of warfarin therapy for atrial fibrillation patients. This allows for delivery of high-quality anticoagulation therapy through frequent testing and appropriate dose adjustment to account for changes in diet, medications and clinical status that may impact the therapy's narrow therapeutic window.
Singer adds, "One of our distinctive findings is that stroke risk continues to increase in patients age 85 and older and that warfarin provides substantial net protection for these elderly patients. A caution is that all these patients were presumably judged by their physicians to be reasonable candidates for warfarin therapy, so these results do not automatically apply to all elderly atrial fibrillation patients."
Funding for the study was provided by the National Institute on Aging, the National Heart, Lung. Blood Institute and the Eliot B. and Edith C. Shoolman fund of the Massachusetts General Hospital.
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