European Breast Cancer Patients to be Treated With Revolutionary Therapy System

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.


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.

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.'

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.

Updated IMPACT Results Confirm that Provenge® Improves Overall Survival in Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC)

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.

Active Cellular Immunotherapies

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.

Results

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.

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.

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].

As previously reported, the most common adverse reactions were chills, fever, headache, aches, influenza-like illness and sweating.

"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."

License Application

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.

New Drug Targeting Advanced Thymic Cancer May Bring Hope to Patients

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.


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.
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.

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%.

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.

Preliminary results of PHA-848125AC, a TRK A antagonist pro, is uced by Nerviano Medical Sciences of Milan, Italy’s largest pharmaceutical research and development facility, showed favorable results in treating the disease.

“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.

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.

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.

Dr. Jeffrey Isaacs of Southwest Hematology Oncology 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.

PHA-848125AC will be administered orally. The study will be open at Scottsdale Healthcare, the Institute Gustave Roussy and the Hopital Larrey in France and at the University of Turin, San Luigi Hospital in Italy.

The intent of the study 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.

For more information about current clinical trials:

• Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma

Also read

• Johnson S B et al. Thymoma: Update for the new millennium. The Oncologist. Vol. 6, No 3, 239- 246, June 2001.
• Lara, Jr P N (2000) Malignant thymoma: current status and future directions. Cancer Treatment Reviews April 2000; 26: 2 127-131.
• Detterbeck FC, Parsons A M Thymic Tumours. The Annals of Thoracic Surgery 2004; 77:1860- 9.
• Eng T et al (2003) Thymic carcinoma: state of the art review. International Journal of Radiation Oncology Biology Physics. Vol 59 No 3.
• Giaccone G Treatment of malignant thymoma. Current Opinion in Oncology 2005 17: 140- 146.
• 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.
• Textbook of Uncommon Cancer (3rd edition) Eds. Raghavan et al. Wiley, 2006.

See PubMed abstracts:

• Nakagawara A Trk receptor tyrosine kinases: a bridge between cancer and neural development Cancer Lett.2001 Aug 28;169(2):107-14.
• Mitsutake N, Yamashita S The role of cancer genes in thyroid cancer and molecular targeted therapy Nippon Naika Gakkai Zasshi. 2009 Aug 10;98(8):1999-2005.

Pralatrexate Approved by FDA as the First Drug for Treatment of Peripheral T-cell Lymphoma

The U.S. Food and Drug Administration (FDA) approved pralatrexate (Folotyn®, Allos Therapeutics), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.

Pralatrexate, also known as 10-propargyl-10-deazaaminopterin, is a folate analog inhibitor of dihydrofolate reductase studied for the treatment of cancer. The drug candidate was approved under the FDA's accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy.

Lymphoma is a cancer of the lymphatic system, which is part of the immune system. There are many types of lymphoma: one type is called Hodgkin's disease, and the rest are called non-Hodgkin's lymphomas. PTCL involves a type of white blood cell called T-cells. It is a relatively rare disease, occurring in less than 9,500 patients each year in the United States.

“Folotyn's approval demonstrates FDA's commitment to the rapid approval of drugs for rare and uncommon diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

When studying a new drug, it can take time to learn whether a drug actually provides real improvement for patients – such as living longer or feeling better. This real improvement is known as a “clinical outcome.” In 1992 FDA instituted accelerated approvals which allow earlier approval of drugs based on a surrogate endpoint, a laboratory measurement or physical sign that can serve as an indirect or substitute measurement for clinical outcomes.

In the case of pralatrexate, this meant the FDA approved the drug based on evidence that it reduces tumor size, because tumor shrinkage is considered reasonably likely to predict a clinical benefit such as extending the survival of cancer patients. Tumor shrinkage was seen on imaging scans in one study. Of 109 patients with PTCL in the trial, 27% had reduction in tumor size.
To speed the drug's availability, pralatrexate was granted priority review, ensuring a review within six months rather than 10 months for a standard review. The drug was also designated as an orphan drug, which provides a variety of financial incentives to manufacturers that develop drugs for a small number of patients with a rare disorder.

The most common adverse reactions seen with pralatrexate were irritation or sores of the mucous membranes such as the lips, the mouth, and the digestive tract, low platelet cell counts, low white blood cell counts, fever, nausea, and fatigue.

Pralatrexate can harm a fetus. Therefore, women should avoid becoming pregnant while being treated with this drug and pregnant women should be informed of the potential risk.
Patients treated with pralatrexate should take folate and vitamin B12 supplements to reduce mucous membrane irritation.

Pralatrexate is manufactured by Allos Therapeutics Inc. of Westminster, Colorado (USA). As a condition of accelerated approval, Allos will conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer.

For more information:

• EMEA - Public Summary of Positive Opinion for Orphan Designation of
  pralatrexate for the treatment of peripheral T-cell lymphoma
  (nodal, other extranodal and leukaemic/disseminated)

Also read these PubMed abstracts:

• O'Connor OA, Horwitz S, Hamlin P, Portlock C, Moskowitz CH, et al. Phase II-I-II study of two different doses and schedules of pralatrexate, a high-affinity substrate for the reduced folate carrier, in patients with relapsed or refractory lymphoma reveals marked activity in T-cell malignancies. J Clin Oncol. 2009 Sep 10;27(26):4357-64. Epub 2009 Aug 3.
• Mould DR, Sweeney K, Duffull SB, Neylon E, et al. A population pharmacokinetic and pharmacodynamic evaluation of pralatrexate in patients with relapsed or refractory non-Hodgkin's or Hodgkin's lymphoma. Clin Pharmacol Ther. 2009 Aug;86(2):190-6. Epub 2009 May 27.
• Marneros AG, Grossman ME, Silvers DN, Husain S, et al. Pralatrexate-induced tumor cell apoptosis in the epidermis of a patient with HTLV-1 adult T-cell lymphoma/leukemia causing skin erosions. Blood. 2009 Jun 18;113(25):6338-41. Epub 2009 Apr 23.
• Rueda A, Casanova M, Quero C, Medina-Pérez A. Pralatrexate, a new hope for aggressive T-cell lymphomas? Clin Transl Oncol. 2009 Apr;11(4):215-20. Review.

The Experience and Impact of Teenage Cancer Diagnosis Reveals Major Struggle

New research provides unique insight into what it is like for teenagers and young people to go through the process of obtaining a cancer diagnosis, revealing stories of prolonged suffering, acute distress and intense frustration for some over their symptoms not being taken seriously.

The study, presented by British researchers at 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, is the first to have asked young people with cancer about their experiences from the time of first symptoms to diagnosis and provides lessons for catching the disease earlier and improving the care and experience of patients in this age group, about whom little is known.

Cancer is rare in teenagers and young people, with those aged between 15 and 24 years accounting for less than two percent of all cancer cases worldwide. But the rates are twice as high as they are in children and the disease is the most frequent cause of death in this age group after accidents. The long-term outcome for some tumor types is thought to be relatively poor compared with that for children and adults and delay in diagnosis is thought to be one of the key factors in this. The problem of diagnostic delay is widely acknowledged but is perhaps the least understood aspect of the young person’s cancer journey.

“While being diagnosed with a potentially life-threatening disease is a distressing experience for any patient, a cancer diagnosis, and the process leading up to it, can have a particularly poignant impact on teenagers because that stage of development already presents significant challenges in developing independence, identity and in coping with the world. Research in this area has been limited and better understanding of the complexities of their experience in the pre-diagnostic period is crucial if we are to provide the most comprehensive and sensitive care and improve their outcomes,” said one of the study’s researchers, Ms Susie Pearce, a health service researcher for young people with cancer at University College Hospital in London.

The researchers conducted narrative interviews with 24 young people aged between 16 and 24, two to four months after they had been diagnosed with solid tumors in one of four major centers in England. The medical notes of each participant were also analyzed in the study.

While the individual experiences varied in terms of how their symptoms evolved and were responded to, several common themes emerged. Key findings included a pattern of young voices not being heard, delays in diagnosis and a misconception among young people and society as a whole that young people don’t get cancer.

“While symptoms in some young people were promptly recognized by GPs and referred to specialists quickly, other patients recounted tales of protracted periods of suffering, with rationalization of their own symptoms or numerous disappointing visits to doctors and hospitals before the cancer was diagnosed,” said Pearce, adding that the time period between first symptoms and diagnosis ranged from eight weeks to 11 years.

Examples of symptoms being missed by general practitioners or accident and emergency doctors included being told it is normal to be tired, that symptoms are due to menstrual problems, fluid on the knee, irritable bowel syndrome, excess weight or lack of exercise.

“One consistent thread through these stories is young people’s perception that they were not being listened to and that cancer was being ruled out on age alone,” explained Pearce. “For instance, one eventually thought she was going mad after three months of headaches and 12 visits to the GP and A&E. Finally, after breaking down at the GP’s surgery, she was referred to the specialist and was later diagnosed with neuroblastoma. It seemed that extreme levels of worry and distress had to be reached before the right course of action was taken.”

In another case, a 22-year-old young woman who was diagnosed with colon cancer that had spread to the liver recounted a frustrating battle to be taken seriously after nine or ten years of suspicious symptoms such as food aversion, abdominal pain, frequent diarrhea and rectal bleeding from the age of 14 and two separate diagnoses of familial adenomatous polyposis, or FAP, a hereditary syndrome that carries a very high risk of colon cancer.

“Basically because I grew up with the symptoms no-one went ding din ding… red light warning, we need to do something about this,” she told the researchers. “I said ‘look, this is ridiculous. I am passing blood a lot, diarrhoea, tummy ache. I want to get it sorted because it’s ruining, not ruining but it’s taking over my life’ …They look at you and they say you are too young for this. If you are old, they will do something about it.”

Pearce noted: “She felt quite strongly that if she had been 40 or 50 her symptoms would have been picked up on at a very early stage and she would have been fine, but lots of cues were missed because nobody was thinking that she could have colon cancer.” Sadly, after her participation in the study, this young woman died.

In another example, a 23-year-old young woman who was diagnosed with ovarian cancer 10 months after her first symptoms said: “I wish they had just listened to me in the beginning. I’d like them more aware so you can’t just be shoved away out the door. It’s your life … it’s your whole world they are talking about and they are not taking it seriously.”

The researchers found that the reaction of others, particularly parents, was important in determining how long the patients were willing to put up with symptoms and how assertive they were at pushing for an answer to their concerns.

“There seemed to be a trigger point at which further help was sought. That threshold came when normal physical, social and emotional functioning became impossible and the symptoms could no longer be dismissed as normal,” Ms Pearce said. “Prompting, confirmation and support from others was crucial in the acknowledgment of threat and seriousness of the need for action.”

The sense of relief once they had arrived in specialist care was striking. They felt they were in safe hands, with experts whom they now had confidence in, the study found. However, some said their struggle to get to that point prompted them to lose trust in their GP or the hospital Accident & Emergency system and that they would be reluctant to seek the help of those professionals again.

“The stories related here are, sadly, far from unique. Doctors should be making urgent referrals when children or young people come to see them several times with the same problem and persistent parental anxiety should be sufficient reason for referral,” Pearce said, adding that the study recommends research into interventions such as education in schools and universities and better education of health professionals, including school nurses, university health centers and general practitioners so that classic signs are investigated properly and promptly.

The 23-year-old ovarian cancer patient’s advice to young people was: “Listen to your intuition and be strong. If you think something is wrong just keep pushing.”

The study was funded by CLIC Sargent, the UK-based children and young people’s cancer charity.

For more information:

• Abstract no: 4170. Experiences of Care proffered papers session, Tuesday 09.00 hrs CEST (Hall 10)

Also read these PubMed abstracts:

• Gurney JG, Krull KR, Kadan-Lottick N, Nicholson HS, Nathan PC, Zebrack B, Tersak JM, Ness KK. Social outcomes in the Childhood Cancer Survivor Study cohort. J Clin Oncol. 2009 May 10;27(14):2390-5. Epub 2009 Feb 17. Review.
• Zeltzer LK, Recklitis C, Buchbinder D, Zebrack B, et al. Psychological status in childhood cancer survivors: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2009 May 10;27(14):2396-404. Epub 2009 Mar 2
• Stein KD, Syrjala KL, Andrykowski MA. Physical and psychological long-term and late effects of cancer. Cancer. 2008 Jun 1;112(11 Suppl):2577-92. Review.
• Zeltzer LK, Lu Q, Leisenring W, Tsao JC, et al. Psychosocial outcomes and health-related quality of life in adult childhood cancer survivors: a report from the childhood cancer survivor study. Cancer Epidemiol Biomarkers Prev. 2008 Feb;17(2):435-46
• Zebrack BJ, Zevon MA, Turk N, Nagarajan R, et al, Psychological distress in long-term survivors of solid tumors diagnosed in childhood: a report from the childhood cancer survivor study. Pediatr Blood Cancer. 2007 Jul;49(1):47-51
• Turner J, Clavarino A, Yates P, Hargraves M, Connors V, Hausmann S. Development of a resource for parents with advanced cancer: what do parents want?
  Palliat Support Care. 2007 Jun;5(2):135-45.
• Van Dijk J, Imhof SM, Moll AC, Ringens PJ, Cohen-Kettenis PT, Rijmen F, Huisman J. Quality of life of adult retinoblastoma survivors in the Netherlands.
  Health Qual Life Outcomes. 2007 Jun 4;5:30.
• Abrams AN, Hazen EP, Penson RT. Psychosocial issues in adolescents with cancer.
  Cancer Treat Rev. 2007 Nov;33(7):622-30. Epub 2007 Apr 16. Review.
• Upton P, Eiser C. School experiences after treatment for a brain tumour.
  Child Care Health Dev. 2006 Jan;32(1):9-17.
• Stam H, Grootenhuis MA, Brons PP, Caron HN, Last BF. Health-related quality of life in children and emotional reactions of parents following completion of cancer treatment.
  Pediatr Blood Cancer. 2006 Sep;47(3):312-9.

Novel Cancer Drug Test May Results in Safer and More Effective Clinical Trials

A group of scientists from Hamburg may have taken a big step towards more effective cancer drug development. Dr Ilona Schonn, Director of Cell Culture Research at Indivumed GmbH, a company specialized in the analysis and procurement of highly standardized tissue samples and data of tumor patients, told the audience at Europe’s largest cancer congress, the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress, September 20 – 24 in Berlin, Germany, that they had developed a preclinical drug test platform that would enable researchers to analyze tumor tissue for individual patient drug responses on the molecular level.

To date most tests for drug metabolism and toxicity testing have used tissue slices of normal organs like liver, kidney and lung. The new test was created specifically for oncology drug testing and uses tumor tissues from colorectal and lung cancer patients.

A major problem of drug development at present is the inability to extrapolate response in preclinical cell models to patients. “Approximately 90% of clinical trials fail because the drugs used are too ineffective or too toxic,” explained Dr Schonn. “Not only does this result in unacceptably high costs for drug development, but it also exposes patients to risks from toxicity or simply wastes their time in testing a substance which proves to be ineffective.”

The problem arises from the fact that patients respond individually to drugs. In addition, each tumor consists of a variety of different cancer cells that interact in different ways with the framework of individual non-tumor cells, resulting in highly variable growth behavior and response to drugs. Dr Schonn and her team set out to try to develop a drug test that would eliminate these problems and provide an accurate model of individual patient response.

“Based on freshly cultivated intact tissue from surgically treated cancer patients we are now able to analyze numerous tumors from different patients, to identify differences in drug response between those patients, and to understand variations of response in cell subtypes within one tumor,” said Dr Schonn.

The new test allows scientists to translate findings from commonly used cell lines to a preclinical model which is as close as possible to using the same drug in the clinical setting, thus enabling a better estimate of the number of patients who are likely to respond to the treatment. It also helps to identify biomarkers that can predict drug response for patients entering a clinical trial, allowing researchers to include only those patients whose participation will provide a significant answer to the question being asked.

“Together with all the clinical patient data and several analytical test systems such as signaling pathway analysis, we have been able to characterize individual tumors in more detail. This will improve the understanding of drug effects and treatments, a step forward towards the goal of individualized cancer therapy,” she said. “The test is of particular interest to pharmaceutical companies because it allows the analysis of samples from meaningful number of patients with different tumors in a short period of time, and can, therefore, accelerate progression of a potential new treatment to clinical trials.”

In addition, it can help gain more knowledge about the mode of action of a new compound in patients, and identify optimal disease areas, for example tumors with particular mutations or over-expression of target receptors, and dosage.

To date the test has only been validated in colon, non-small cell lung (NSCLC), and breast cancer tumors but there is no reason to think that it would not be equally accurate in other solid tumor types, the scientists say.

“Because the test allows us to maintain the complex environment of the primary cancer tumor, we believe that it holds out great promise for the quick and effective elucidation of response to anticancer drugs,” said Dr Schonn. “We hope to be able to apply it to a growing number of drugs emerging from the labs of pharmaceutical companies to help to shorten development time and to make clinical trials both more efficient and safer for patients.”

The test can analyze numerous tumors from different patients, identify the patients’ diverse reactions to the test compounds and elucidate their varying effects on cell subtypes within the same tumor. Says Prof Dr Hartmut Juhl, CEO and founder of Indivumed. “In the long run, our test paves the way to personalized medicine, because it helps to understand and to embrace the individual reactions of the patients to a certain therapy.”

For more information:

• Abstract no: 1013, Basic Science/Translational Research poster discussion, Wednesday 17.00 – 18.00 hrs CEST (Hall 14.2)

Bevacizumab Data Gives Hope to Colorectal Cancer Patients with Liver Metastases

New data from several studies presented at the joint multidisciplinary meeting of ECCO 15 (European CanCer Organisation) and ESMO 34 (European Society for Medical Oncology) in Berlin, Germany, confirm unique benefits of bevacizumab (Avastin®, Roche, Basel, Switzerland), an antibody that specifically binds and blocks VEGF (vascular endothelial growth factor), and capecitabine (Xeloda®, Roche, Basel, Swizerland), a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs, in treatment of colon cancer.

Colorectal cancer is the second most common cause of death from cancer across all tumor types in Europe and is the third most commonly reported cancer in the world.

Bevacizumab in combination with chemotherapy led to shrinkage or disappearance (overall response rate) of liver metastases (disease that has spread to the liver) in 78% of patients with advanced colorectal cancer. As a result, one third (33%) of patients who were initially unable to undergo surgery were eligible to undergo a potentially lifesaving surgery. Complete surgical removal of the metastases was achieved in 56% of all bevacizumab-treated patients.

II BOXER study
The multicentre phase II BOXER study, a single arm phase II study, investigated the efficacy and safety of bevacizumab in combination with oral capecitabine and intravenous oxaliplatin (NO16968 XELOX trial, an open-label, randomised, phase III study of oral capecitabine in combination with intravenous oxaliplatin versus 5-fluorouracil/leucovorin (5-FU/LV) as adjuvant therapy for patients with stage III colon cancer who have undergone surgery) in patients considered unsuitable for upfront resection (surgical removal) of their liver metastases.

Response rates in this trial were measured by RECIST criteria. Secondary objectives of BOXER trial included complete resection rate, safety and feasibility of the regimen, PFS and overall survival.

“The data from BOXER shows that bevacizumab in combination with standard chemotherapy has the ability to shrink metastatic lesions which might allow surgical removal and therefore offer a potential for cure for patients with advanced disease,” explained Professor David Cunningham, Head of the Gastrointestinal Unit at the Royal Marsden Hospital, UK.

First BEAT
Data from the large, observational First BEAT phase IV trial assessing the safety and efficacy of bevacizumab in almost 2,000 previously untreated patients with mCRC in combination with a variety of standard chemotherapies, showed that bevacizumab -based treatment delivers the same benefits to all patients including those aged above 65 years who represent the majority of people with advanced colorectal cancer. This is an important finding as older patients are often under-represented in clinical trials. The study results showed that the time patients lived without their disease advancing (PFS) was similar across age groups – 10.8 months for those below 65 years, 11.2 months for those between 65 and 74 years and 10 months for those 75 years and older.

The most common chemotherapy regimens combined with bevacizumab in First BEAT were FOLFOX, XELOX, FOLFIRI (oxaliplatin, fluorouracil and irinotecan) and capecitabine. The primary endpoint of First BEAT was safety and secondary objectives were PFS and overall survival.

NO16968 (XELOXA) study
Patients taking capecitabine with oxaliplatin immediately after surgery live disease free for longer compared to those treated with commonly used chemotherapy regimen. New results for capecitabine in early colon cancer were also presented at the ECCO 15 - ESMO 34 meeting. The pivotal NO16968 (XELOXA) study, the largest-ever study of patients with stage III colon cancer, showed that the three year disease-free survival (DFS) for patients receiving XELOX was 70.9%, superior to the 5-FU/LV arm (66.5%) (HR=0.80 (95% CI: 0.69-0.93), p=0.0045). The DFS result obtained with XELOX is similar to that shown in trials evaluating the use of FOLFOX in patients with stage III colon cancer.

"We know that XELOX helps keep patients free from recurrence of their cancer longer,’’ said Dr Dan Haller, Professor of Medicine, University of Pennsylvania. "These results now confirm that patients have an additional option for the treatment of stage III colon cancer. In these potentially curable patients, XELOX offers the additional benefit of an oral medication, Xeloda."

"Colorectal cancer sadly claims more than 600,000 lives each year, despite the treatment advances made in the last decade” said William M. Burns, CEO of Roche’s Pharmaceuticals. “Today’s announcements about Avastin and Xeloda are therefore very welcome news for patients and their families as they offer more options for fighting this disease and hope that some patients may even have the potential to be cured” he added.

Images courtesy American Society of Clinical oncology (ASCO) and Roche Pharmaceuticals.

Overweight and Obesity Causes over 124,000 New Cancers a Year in Europe

According to estimates from a new modeling study, at least 124,000 new cancers in 2008 in Europe may have been caused by excess body weight. The proportion of cases of new cancers attributable to a body mass index of 25kg/m2 or more were highest among women and in central European countries such as the Czech Republic, Latvia, Slovenia and Bulgaria.

The lead author of a study called ‘Incident cancer burden attributable to excess body mass index in 30 European countries’, published in the International Journal of Cancer, Dr Andrew Renehan, told oncologists and other medical professionals gather together in Berlin, Germany during the combined 15th congress of the European CanCer Organisation and the 34th congress of the European Society for Medical Oncology: “As more people stop smoking and fewer women take hormone replacement therapy, it is possible that obesity may become the biggest attributable cause of cancer in women within the next decade.”

Dr Renehan, who is a senior lecturer in cancer studies and surgery at the University of Manchester (UK), and his colleagues in the UK, The Netherlands and Switzerland, created a sophisticated model to estimate the proportion of cancers that could be attributed to excess body weight in 30 European countries. Using data from a number of sources including the World Health Organization and the International Agency for Research on Cancer, they estimated that in 2002 (the most recent year for which there are reliable statistics on cancer incidence in Europe) there had been over 70,000 new cases of cancer attributable to excess BMI out of a total of nearly 2.2 million new diagnoses across the 30 European countries.

The percentage of obesity-related cancers varied widely between countries, from 2.1% in women and 2.4% in men in Denmark, to 8.2% in women and 3.5% in men in the Czech Republic. In Germany it was 4.8% in women and 3.3% in men, and in the UK it was 4% in women and 3.4% in men.

Then, the researchers projected the figures forward to 2008, taking into account what was known about shifts in the distribution of BMI, the dramatic decline in women’s use of hormone replacement therapy (HRT) from 2002 onwards following research that showed it increased the risk of breast cancer, and the wider use of PSA screening for prostate cancer in men.

They found that the number of cancers that could be attributed to excess body weight increased to 124,050 in 2008. In men, 3.2% of new cancers could be attributed to being overweight or obese and in women it was 8.6%. The largest number of obesity-related new cancers was for endometrial cancer (33,421), post-menopausal breast cancer (27,770) and colorectal cancer (23,730). These three accounted for 65% of all cancers attributable to excess BMI.

“I must emphasize that we are trying not to be sensationalist about this,” said Dr Renehan. “These are very conservative estimates, and it’s quite likely that the numbers are, in fact, higher.”

The number of new cases of obesity-related esophageal cancer was particularly high in the UK relative to the rest of Europe. “This country accounts for 54% of new cases across all 30 countries,” said Dr Renehan. “This may be due to synergistic interactions between smoking, alcohol, excess body weight and acid reflux – and is currently an area where research is required.”

Until 2002 when HRT use dropped dramatically following the results of the Women’s Health Initiative Trial (USA) that showed an increased risk of breast cancer in women taking HRT, Dr Renehan said that HRT masked and diluted the effects of obesity on the incidence of breast cancer. “In women who used HRT it wasn’t clear what proportions of breast cancers were caused by HRT or by obesity. In women who don’t take HRT, the effect of obesity was much clearer. Now that far fewer women are using HRT, it is much easier to see the effect of obesity on the incidence of breast cancer, and also on endometrial cancer. Consequently, the proportions of these cancers attributable to obesity have increased.”

Dr Renehan said that although European countries were taking steps to tackle the obesity epidemic, this study underlined the urgency of the task and the scale of the problems caused by increasingly overweight populations.

“The overall size of the burden of increasing cancer incidence should inform health policy. For example, it is clear that, in both relative and absolute terms, obesity-related cancer is a greater problem for women than for men. At a country level, it is a greater problem for central European countries like the Czech Republic, whereas it is less of a problem in France and Denmark. Similarly, obesity-related esophageal cancer seems to be a substantial and unique problem in the UK.

“The study also identifies priorities for research into certain cancers, namely endometrial, breast and colorectal cancers. In the face of an unabating obesity epidemic, and apparent failure of public health policies to control weight gain, there is a need to look at alternative strategies, including pharmacological approaches.”

Dr Renehan’s own research is trying to relate these epidemiological findings back to the biological mechanisms that are at work. His research uses the observed interactions between excess BMI and cancer risk to guide questions in the laboratory.

For more information:

• ECCO15 – ESMO 34 Abstract no: 327, Oncopolicy session: Drug and lifestyle mediated prevention initiatives in Europe. Thursday 11.15-12.15 hrs CEST (Hall 3)

New European Academy of Cancer Sciences will Help Shape Future Oncology Policy

A new initiative designed to inform and educate policymakers at national, European, and global level about the needs of the oncology community was launched at Europe’s largest cancer congress, ECCO 15 – ESMO 34, the 15th congress of the European CanCer Organisation and the 34th congress of the European Society for Medical Oncology in Berlin, Germany.

Professor Alexander Eggermont, President of the European CanCer Organisation (ECCO), told the conference that the European Academy of Cancer Sciences would help keep the interests of cancer patients at the forefront of the policy agenda, and avoid policy decisions that had a negative impact on the practice of oncology medicine.

The Academy will be a virtual body, grouping together representatives of all cancer disciplines with outstanding scientific and academic backgrounds to provide knowledgeable and unbiased advice on matters of policy and priorities at the national, European and global level under the auspices of ECCO. “We hope it will become an important reference point for policymakers and professionals in the field of oncology research and oncology care, where they can go to ask questions and receive suggestions and advice. It will be an independent organism, with the secretariat provided by ECCO, with whose Policy Committee it will work closely in the beginning,” said Prof Eggermont.

“We hope that, by keeping a close eye on policy developments that might affect cancer and offering expert advice to those responsible for decision-making, we will be able in future to avoid some of the recent decisions that have had so much potential to harm cancer patients and the oncology community. For example, it is generally acknowledged that the Clinical Trials Directive has had a catastrophic effect on the independent evaluation and comparison of drugs by academic clinical researchers. It has greatly reduced the amount of academic clinical research in oncology in Europe in all treatment categories (surgery, radiotherapy and systemic medicinal therapy) and in their combinations. In this case the academic community simply woke up too late, when the damage was already done,” he said.

Another example cited by Prof Eggermont was the Physical Agents (Electromagnetic Fields) Directive, which could have stopped all MRI scanning in Europe. “Eight million MRI patient examinations per year are carried out in Europe,” he said, “and the Directive set limits to occupational radiation exposure which meant that anyone working or moving near MRI equipment would breach them, thus making it possible for them to sue their employers. Luckily, in this case, oncologists and other specialists who would have been affected reacted in time – but only just. These are the kind of situations that we hope could be avoided by early input from the Academy.”

A founding group of 114 Academy members has been set up. Thirty of these members were chosen on the basis of their experience and reputation, and in turn they voted for the other members. Among the distinguished experts co-opted in the first place are Nobel prize-winners Professor Harald zur Hausen and Sir Paul Nurse; leading epidemiologist Sir Richard Peto; and the eminent Italian cancer surgeon Professor Umberto Veronesi.

Members of the ECCO Board and Policy Committee also belong to the founding group. Elected membership is a life-long distinction, and the Academy hopes to introduce new blood by electing up to 50 new members per year.

Requests to the Academy for information and advice may come from many quarters – patient organisations and health care professionals, as well as policy makers and politicians. “The ECCO Policy Committee will initially flag up issues where the Academy could make use of its expertise,” said Professor Eggermont “but at a later stage we hope that they will be able to interact directly with policymakers, for example with the European Commission about the content of future Framework Programmes for research.”

“Members are excited about what they see as a genuine intellectual challenge, responding to real needs,” said Professor Eggermont. “In the first place the Academy will put its collective intelligence to preparing a paper on what needs to be done to boost cancer research in Europe. The paper, which we hope will be produced in the next year, will look at barriers to research and how they can be addressed, as well as proposing priorities.

“We are optimistic that this new initiative will have a positive effect on all those associated with cancer, be they patients, doctors, scientists or carers, and we look forward to the time when cancer takes its rightful place in the policy agenda,” he said.

For more information:

• Presidential session 1, The unified approach: meeting the cancer challenges in the next decade, Monday 13.15-16.0 hrs CEST (Hall 1)

Prostate Cancer Kills - Every 20 Minutes

Every 20 minutes, a son, father or grandfather will die from this disease. To create awareness, Hank Oprinski, CEO at Capital Earnings & Research, is launching his nationwide tour to inform corporations, chambers of commerce, golfing communities, economic clubs, universities and other interested civic organizations to be proactive about prostate cancer.

This year in the United States, approximately 190,000 men will be diagnosed with the disease. That means a new case will occur every 2 minutes and 30 seconds. "I'm a prostate cancer survivor and live a relatively normal life." says Oprinski.

"Cancer seminars are happening across the country and in most corporate backyards. The acceptance of the concept of these presentation demonstrates that organizations care about their neighborhood and the people who dedicate themselves to the prosperity of that organization. It shows involvement and organizational interest because people want to do something to help someone else," says Oprinski.

His success comes from his demonstration of how he copes with prostate cancer, involves his family for support and continues to build a successful business while addressing how a partner can help patients through challenging times, how support groups can play a role, the importance of second opinions, how patients can, and need, to get to know their own body, how patients can control their destiny and medical outcome. Oprinski also talks about the never-spoken-of side-effects of prostate cancer and talk about prevention by explaining ways to minimize the risk of prostate cancer

Oprinski has worked in 26 countries with a career that has taken him to Europe, the Middle East and Asia. He is a former Executive Vice President of BCG, Inc. and is the current Managing Partner and CEO associate of Capital Partners Limited, LLP. Oprinski is a recognized guest speaker and seminar instructor of international strategic planning, the author of "Customer Service, the Strategy for the 2000's" and a general aviation pilot.

September Is Prostate Cancer Awareness Month.

For more information:

• To schedule an event or for more information, contact Hank Oprinski at (256) 417-6084

Study Points to Possible Reasons Why African-Americans Fare Worse With Cancer.

Among man and women with sex-specific cancers, including breast, ovarian, and prostate cancer, African Americans have a higher mortality rate than Caucasian. This is the conclusion of an analysis of clinical trial data which implicates biological factors behind worse outcomes for African-Americans.

After analyzing almost 20,000 patient records from the Southwest Oncology Group's (SOG) database of clinical trials finds, the researchers, for the first time, noted potential biological factors as an explanation why African-American patients with sex-specific cancers tend to die earlier than patients of other races. This despite identical medical treatment regimens for all patients involved and enrollment in the same phase III SWOG trials with uniform stage, treatment, and follow-up. Other confounding socioeconomic factors were also controlled.

Breast cancer
In unrelated earlier studies, observed variations in breast cancer survival by racial/ethnic background had been attributed to a number of varying factors, including differences in clinical and pathologic disease features at diagnosis and economic resource inequities that may affect treatment access and quality.

Whether African-American women have biologically more aggressive breast carcinoma compared with women of other races and whether race acts as a significant independent prognostic factor for was a question that for many years remained unanswered. The general consensus was that race could be a surrogate for socioeconomic status (SES). Researchers in often concluded that a mortality deficit for African-American women relative to Caucasian women, was due to greater mortality from noncancer causes among African-Americans. A retrospective literature review in 2002 by Cross et al demonstrated that while socioeconomic factors replaced race as a predictor of worse outcome after women were diagnosed with breast carcinomas, black women generally presented more advanced disease that appeared more aggressive biologically at a younger age compared with white women.

Prostate cancer
Similar racial/ethnic disparities have been observed in prostate cancer rates. Large population-based cross-sectional studies show the highest incidence and mortality rates among African-Americans followed by non-Hispanic Whites, Hispanics, and Asian/Pacific Islanders. In many studies African-Americans men have two- to fivefold increased risk of prostate cancer deaths in comparison to non-Hispanic Whites across all levels of their socioeconomic status (SES). Based on these results, many researchers felt that socioeconomic status alone could account for the greater burden of prostate cancer among African-American men.

Non Sex-specific cancers
Furthermore, various key studies into other major cancers, including non sex-specific cancer such as colon cancer, generally attributed to the disparity in survival in racial/ethnic settings to a number of varying causes, including diagnosis at later disease stage and other unfavorable disease features, inadequate treatment, and socioeconomic factors.

After analyzing the results of the Eastern Cooperative Oncology Group's E3200 trial, Dr Paul Catalano, D.Sc.,of the Harvard School of Public Health and the Dana-Farber Cancer Institute in Boston found that African Americans with metastatic colorectal cancer (MCC) do not fare as well as Caucasians when, in a specific treatment, bevacizumab (Avastin), a targeted vascular endothelial growth factor inhibitor, is added to the FOLFOX regimen.

In analyzing the data accumulated in the trial that included 713 Caucasians and 66 African Americans, Dr. Catalano and colleagues determined that, in the E3200 trial, African Americans had a lower objective response rate - 3% versus 12.5% (P=0.02), a non-significant shorter time of progression-free survival (P=0.08) and a significantly shorter overall survival (10.2 months versus 11.8 months, (P=0.03). They noted that and this difference remained after adjustment for treatment, gender, age and performance status.

Analytical outcome
The SOG analyses for the first time, shows overwhelming evidence pointing to biological or host genetic factors as the potential source of the survival gap between African Americans and Caucasian patients.

Of 19 457 patients registered, 2308 (11.9%, range = 3.9%–21.6%) were African American. After adjustment for prognostic factors, African American race was associated with increased mortality in patients with early-stage premenopausal breast cancer (hazard ratio [HR] for death = 1.41, 95% confidence interval [CI] = 1.10 to 1.82; P = .007), early-stage postmenopausal breast cancer (HR for death = 1.49, 95% CI = 1.28 to 1.73; P < .001), advanced-stage ovarian cancer (HR for death = 1.61, 95% CI = 1.18 to 2.18; P = .002), and advanced-stage prostate cancer (HR for death = 1.21, 95% CI = 1.08 to 1.37; P = .001).

No statistically significant association between race and survival for lung cancer, colon cancer, lymphoma, leukemia, or myeloma was observed. Additional adjustments for socioeconomic status did not substantially change these observations. Ten-year (and median) overall survival rates for African American vs all other patients were 68% (not reached) vs 77% (not reached), respectively, for early-stage, premenopausal breast cancer; 52% (10.2 years) vs 62% (13.5 years) for early-stage, postmenopausal breast cancer; 13% (1.3 years) vs 17% (2.3 years) for advanced ovarian cancer; and 6% (2.2 years) vs 9% (2.7 years) for advanced prostate cancer.

Access to Quality treatment
"When you look at the dialogue about the issue of race and cancer survival that's gone on over the years," says the paper's lead author, Kathy Albain, M.D., a breast and lung cancer specialist at Loyola University's Cardinal Bernardin Cancer Center, "it always seems to come down to general conclusions that African-Americans may in part have poorer access to quality treatment, may be diagnosed in later stages, and may not have the same standard of care delivered as Caucasian patients, leading to a disparity in survival."

The study, published online by the Journal of the National Cancer Institute (JNCI), found that when treatment was uniform and differences in tumor prognostic factors, demographics, and socioeconomic status were controlled, there was in fact no statistically significant difference in survival based on race for a number of other cancers -- lung, colon, lymphoma, leukemia, and multiple myeloma.

"The good news is that for most common cancers," Albain says, "if you get good treatment, your survival is the same regardless of race. But this is not the case for breast, ovarian, and prostate cancers."

Even with good treatment by the same doctors, African-American patients with one of these three cancers faced a significantly higher risk of death than did other patients, ranging from a 21% higher risk for those with prostate cancer to a 61% higher risk for ovarian cancer patients.
The elimination of treatment and socioeconomic factors as the cause of this higher mortality "implicates biology," says study co-author Dawn L. Hershman, M.D., of the Columbia University College of Physicians and Surgeons.

"There may be differences in genetic factors by race that alter the metabolism of chemotherapy drugs or that make cancers more resistant or more aggressive," she adds.

Earlier this year, Hershman, et al published a smaller study that found that, at least with breast cancer, disparities in survival based on race persist even after adjusting for differences in treatment. That study, published in the May 2009 issue of Journal of Clinical Oncology, analyzed data on 634 breast cancer patients.

"Our study of multiple cancers is distinguished from others that have looked at race-based disparities by its size and by the source of its data," says Joseph Unger of the Southwest Oncology Group's Statistical Center, who was statistician and co-author on the new JNCI study.
The study analyzed records from 35 clinical trials - going back as far as 1974 - that had been conducted by the Southwest Oncology Group, an NCI-sponsored cooperative group headquartered at the University of Michigan. Using data from clinical trials, which are already controlled for a range of potentially confounding factors such as differences in diagnosis, treatment, and follow-up, helps throw the remaining factors into sharper relief, according to Frank L. Meyskens, Jr., M.D.

"It's because of the similar way that people are treated on clinical trials that these differences are even detectable," he says. Meyskens is associate chair for Cancer Control and Prevention for the Southwest Oncology Group and director of the University of California-Irvine's Chao Family Comprehensive Cancer Center.

Long term prediction
The urgency of addressing the reasons for racial disparities in outcomes - both sociological and biological - is amplified by another recent study in the Journal of Clinical Oncology. In this study, Benjamin Smith and colleagues predict that cancer incidence among minorities will nearly double in the coming decades, increasing 99% by 2030 compared to an expected 31% increase among whites. Overall, from 2010 to 2030, the percentage of all cancers diagnosed in older adults will increase from 61% to 70%, and the percentage of all cancers diagnosed in minorities will increase from 21% to 28%

Disparities in Cancer Care
In 2008, the American Society of Clinical Oncology (ASCO), the world’s leading professional organization representing physicians who treat people with cancer, published a ‘Disparities in Cancer Care’ policy statement that recommends a set of strategies designed to address the disparities of cancer care experienced by underserved and minority populations.

The recommendations offered by ASCO suggest that strategies should focus on education, prevention, diagnosis, and treatment and should discuss issues regarding the resources and funding routinely available, talk about misconceptions regarding clinical trials and cancer research, address lack of minority representation among oncologists. The authors of the ASCO policy statement feel that addressing these topics, coupled with improved access to care, are likely to yield improved outcomes for minority cancer patients.

"The elimination of socioeconomic and healthcare access disparities must be a priority in the United States," says Lisa Newman, M.D., director of the Breast Care Center at the University of Michigan Comprehensive Cancer Center. "However, Dr. Albain's landmark study demonstrates that further investigation of race- or ethnicity-associated differences in primary tumor biology is also important."

John Crowley, Ph.D., of the Southwest Oncology Group Statistical Center and Charles A. Coltman, M.D., of the University of Texas Health Science Center were also coauthors of the study, which was funded by the National Cancer Institute.

The Southwest Oncology Group is one of the largest cancer clinical trials cooperative groups, with a network of almost 5,000 physician-researchers practicing at more than 500 institutions, including 19 of the National Cancer Institute-designated cancer centers. The Group is headquartered at the University of Michigan in Ann Arbor, Mich. The Group has an operations office in San Antonio, Texas and a statistical center in Seattle, Washington.

For more information:

• Albain KS, Unger JM, Crowley JJ, Coltman, Jr CA, Hershman DL, Racial Disparities in Cancer Survival Among Randomized Clinical Trials Patients of the Southwest Oncology Group Journal of the National Cancer Institute Advance Access published online on July 7, 2009 JNCI Journal of the National Cancer Institute.
• Raghavan, D, Perez EA, Harvey HA. Disparities in Cancer Care (2008 educational handbook)
• Cancer Care in Minority Populations (Educational session, ASCO 2008 Annual meeting, chair Raghavan D, Genitourinary cancer Track).
• Catalano PJ, Mitchell EP, Giantonio BJ, Meropol NJ Benson AB. Outcomes differences for African Americans and Caucasians treated with bevacizumab, FOLFOX4 or the combination in patients with metastatic colorectal cancer (MCRC): Results from the Eastern Cooperative Oncology Group Study E3200. Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 4100

Also read these PubMed Abstracts:

• Albain KS, Unger JM, Crowley JJ, Coltman CA Jr, Hershman DL. Racial Disparities in Cancer Survival Among Randomized Clinical Trials Patients of the Southwest Oncology Group. J Natl Cancer Inst. 2009 Jul 7. [Epub ahead of print].
• Hershman DL, Unger JM, Barlow WE, Hutchins LF, Martino S, et al. Treatment quality and outcomes of African American versus white breast cancer patients: retrospective analysis of Southwest Oncology studies S8814/S8897. J Clin Oncol 2009 May 1;27(13):2157-62. Epub 2009 Mar 23.
• Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol. 2009 Jun 10;27(17):2758-65. Epub 2009 Apr 29.
• McKoy JM, Samaras AT, Bennett CL. Providing cancer care to a graying and diverse cancer population in the 21st century: are we prepared? J Clin Oncol 2009 Jun 10;27(17):2745-6. Epub 2009 Apr 29
• Breslin TM, Morris AM, Gu N, Wong SL, Finlayson EV, Banerjee M, Birkmeyer JD. Hospital Factors and Racial Disparities in Mortality After Surgery for Breast and Colon Cancer. J Clin Oncol. 2009 May 26. [Epub ahead of print]
• Sloane D. Cancer epidemiology in the United States: racial, social, and economic factors. Methods Mol Biol. 2009;471:65-83.
• Resnick MJ, Canter DJ, Guzzo TJ, Brucker BM, Bergey M, Sonnad SS, Wein AJ, Malkowicz SB. Does race affect postoperative outcomes in patients with low-risk prostate cancer who undergo radical prostatectomy? Urology. 2009 Mar;73(3):620-3. Epub 2008 Dec 18
• Cheng I, Witte JS, McClure LA, Shema SJ, Cockburn MG, John EM, Clarke CA. Socioeconomic status and prostate cancer incidence and mortality rates among the diverse population of California. Cancer Causes Control. 2009 Jun 13. [Epub ahead of print]
• Lamb DS, Bupha-Intr O, Bethwaite P, Murray J, Nacey J, Russell G, Delahunt B. Prostate cancer--are ethnic minorities disadvantaged? Anticancer Res. 2008 Nov-Dec;28(6B):3891-5.
• Lathan CS, Neville BA, Earle CC. The effect of race on invasive staging and surgery in non-small-cell lung cancer. J Clin Oncol. 2006 Jan 20;24(3):413-8. Epub 2005 Dec 19.
• Norton KS, Johnson LW, Li BD. Compliance and outcomes: do African Americans with advanced breast cancer fare worse? J La State Med Soc. 2005 Jan-Feb;157(1):28-30.
• Dignam JJ, Colangelo L, Tian W, Jones J, Smith R, et al. Outcomes among African-Americans and Caucasians in colon cancer adjuvant therapy trials: findings from the National Surgical Adjuvant Breast and Bowel Project. J Natl Cancer Inst. 1999 Nov 17;91(22):1933-40.
• Henson DE, Chu KC, Levine PH. Histologic grade, stage, and survival in breast carcinoma: comparison of African American and Caucasian women. Cancer 2003 Sep 1;98(5):908-17.
• Dignam JJ, Redmond CK, Fisher B, Costantino JP, Edwards BK. Prognosis among African-American women and white women with lymph node negative breast carcinoma: findings from two randomized clinical trials of the National Surgical Adjuvant Breast and Bowel Project (NSABP). Cancer 1997 Jul 1;80(1):80-90.
• Cross CK, Harris J, Recht A. Race, socioeconomic status, and breast carcinoma in the U.S: what have we learned from clinical studies. Cancer 2002 Nov 1;95(9):1988-99.
• Dignam JJ. Efficacy of systemic adjuvant therapy for breast cancer in African-American and Caucasian women. J. Natl. Cancer Inst Monogr. 2001;(30):36-43.
• Dignam JJ. Differences in breast cancer prognosis among African-American and Caucasian women. CA cancer J. Clin 2000 Jan-Feb;50(1):50-64.
• Joslyn SA, West MM. Racial differences in breast carcinoma survival. Cancer 2000 Jan 1;88(1):114-23.
• Eojcik BE, Spinks MK, Optenberg SA. Breast carcinoma survival analysis for African American and white women in an equal-access health care system. Cancer 1998 Apr 1;82(7):1310-8.
• Mayberry RM, Coates RJ, Hill HA, Click LA, Chen VW, et al. Determinants of black/white differences in colon cancer survival. J Natl Cancer Inst. 1995 Nov 15;87(22):1686-93.

Images courtesy American Society of Clinical oncology (ASCO)

No Improvement in Local Tumor Response by adding Oxaliplatin to Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer

A large, multicenter Italian study has found that adding oxaliplatin (Eloxatin, Sanofi-Aventis) to standard preoperative radiochemotherapy in patients with locally advanced rectal cancer does not improve tumor shrinkage.

However, preliminary and exploratory data from the study, presented on Saturday, May 30, 2009 by Carlo Aschele, MD, PhD, E.O. Ospedali Galliera, (Mura delle Cappuccine, 1416128 Genova (Ligurie), Italy, Phone +39 010 5 6321) during the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held from May 27 – June 2, 2009 in Orlando, Florida, suggest that it may reduce the number of distant metastases.

Chemotherapy and radiation are often administered before surgery for rectal cancer to shrink the tumor and make it easier to remove. Previous results from this study showed that although adding oxaliplatin to standard chemotherapy increased some side effects, especially diarrhea, it did not affect the ability to deliver the full course of radiation therapy or to perform surgery. Oxaliplatin has been found effective and is commonly used in patients with more advanced colon and rectal cancer.

In this phase III trial, 747 patients with locally advanced rectal cancer were randomized to receive standard preoperative chemoradiotherapy or the standard plus oxaliplatin. Researchers found no significant difference between the two groups in terms of tumor reduction: 16 percent of patients in both groups had no tumor present at the time of surgery, and 29 percent in the oxaliplatin group had mildly invasive tumors (T1 or T2) without nodal involvement, compared with 30 percent in the control group. There was also no significant difference in the number of patients who had cancer in the lymph nodes (27 percent in the oxaliplatin group versus 25 percent in the control group). Consistently, the proportions of patients who could have conservative surgery were similar between the two arms.

In an unplanned analysis, when looking at intra-abdominal disease spread at the time of surgical removal of the primary tumor, only 0.5 percent of patients in the oxaliplatin group (2 patients) had distant metastases, versus 3 percent in the control group (11 patients), a difference that was statistically significant.

“Although adding oxaliplatin to the current standard of care did not improve tumor response rates, we found this course of treatment was associated with a reduced number of early distant metastases in the abdomen in a very small number of patients,” said Carlo Aschele, MD, PhD, attending physician and lead clinician in Colorectal/Gastrointestinal Cancer in the Department of Medical Oncology and Cancer Prevention at E.O. Ospedali Galliera in Genoa, Italy, and the study’s first author.

“Although the numbers are very small and the analysis of distant metastases was unplanned and exploratory, the difference is significant and indicates that the lack of an effect on local tumor shrinkage does not necessarily imply a lack of effect on micrometastases at distant sites. Longer follow-up is necessary to assess whether treatment with oxaliplatin will have an effect on recurrence rates or survival.”

Note: This article contains updated data not published in the original ASCO 2009 abstract

For more information:

• Aschele C, Pinto C, Cordio S, Rosati G, Tagliagambe A, Artale S, Rosetti P, Lonardi S, Boni L, Cionini L. Preoperative fluorouracil (FU)-based chemoradiation with and without weekly oxaliplatin in locally advanced rectal cancer: Pathologic response analysis of the Studio Terapia Adiuvante Retto (STAR)-01 randomized phase III trial. Abstract: CRA4008
• American Society of Clinical Oncology (ASCO)