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Gemcitabine plus Bevacizumab no better than Gemcitabine alone in Clinical Study of 600 Patients with Pancreatic Cancer
volume 6 | issue 2
February 2007Page 137
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Recent results of a nationwide study of a new combination of drugs to treat pancreatic cancer show that the rare but deadly disease still has the upper hand. The study was conducted by a national consortium of cancer researchers called the Cancer and Leukemia Group B (CALGB). The CALGB Gastrointestinal Cancer Committee, which designed the study, is headed by Dr. Richard M. Goldberg, professor of medicine, chief of hematology-oncology, and associate director for clinical research at the UNC Lineberger Comprehensive Cancer Center. The study, funded by the National Cancer Institute, was presented January 21 at the American Society of Clinical Oncology’s Gastrointestinal Cancer Symposium in Orlando, Florida. The nine co-authors were from Memorial Sloan-Kettering Cancer Center, Duke University Medical Center, the University of Chicago and Northwestern University Medical Center. Principal investigator is Dr. Hedy Kindler, associate professor of medicine at the University of Chicago. About 30,000 new cases of pancreatic cancer are diagnosed each year and the overwhelming majority of those new cases will survive only a few months. The disease usually is diagnosed late and, in most cases, doesn’t respond to chemotherapy. While great strides have been made in diagnosing and treating most cancers, “pancreatic cancer is particularly resistant to current therapies,” said Goldberg, “but a recent report offered a glimmer of hope.” That small trial from the University of Chicago used gemcitabine (a chemotherapeutic agent) plus bevacizumab (trade name AvastinŽ) to treat pancreatic cancer patients. Promising results showed an increase in survival time from the typical 4-6 months to nearly 9 months. AvastinŽ, an angiogenesis inhibitor, has been shown to be successful in treating colon, lung and other cancers. Angiogenesis inhibitors limit the growth of new blood vessels and make those blood vessels more easy for drugs to pass through allowing chemotherapy to penetrate tumors more effectively. The hopeful results of the earlier trial led the CALGB to conduct a larger national trial. In just under 2 years, over 600 patients were enrolled making this “one of the largest trials on pancreatic cancer ever undertaken,” according to Goldberg. “Getting this number of patients enrolled in such a short time shows the intense interest in finding better treatment options for patients with cancer of the pancreas,” he said. The patients were men and women, most in their middle 60’s, whose disease had already spread beyond the pancreas. Half the patients continued standard therapy (gemcitabine plus a placebo) while the other half took the combination of drugs used in the Chicago trial. Near the conclusion of the project, it became apparent that the new treatment regimen was no better than gemcitabine alone as no difference was observed in survival rates between the 2 groups. At that time, the randomization scheme was revealed, allowing the remaining patients to be treated according to their physician’s discretion. “The primary question was whether an angiogenesis inhibitor combined with a chemotherapeutic agent would improve survival in patients with pancreatic cancer. The answer was clearly no,” Goldberg said. Other aspects of the project included studies still underway to help unravel the molecular biology of the disease, assess the quality of life of enrolled patients, and economic issues. “The potential for side effects and tumor shrinkage are influenced by the patient’s unique genetics that will ultimately affect prognosis. Tumor shrinkage will also affect quality of life and economic aspects of the disease,” Goldberg explained. “Regrettably, this combination of drugs that first appeared to be so hopeful, failed to affect this tumor like it does other tumors.” Noting that treatment effectiveness found in small trials is not always confirmed in larger studies of patients, Goldberg said this larger trial had a more diverse patient population than the Chicago study. “The patient mix was more consistent with the typical patient mix across the country and this probably was a factor in our results differing from those seen in the group of patients from Chicago.” Still, the UNC researcher said that results from a negative study give valuable insights into the nature of pancreatic cancer, thus improving our understanding for improved patient care and quality of life. “Results like these demonstrate that research needs to be disease-specific. Investigations will continue to attack this disease,” Goldberg said. The CALGB co-authors included Drs. Hedy Kindler and Richard Schilsky from the University of Chicago, Dr. Deborah Schrag from Memorial Sloan Kettering Cancer Center, Dr. Mary Mulcahy from Northwestern University Medical Center, Dr. Herbert Hurwitz from Duke University Medical Center, Dr. Howard McLeod from the University of North Carolina at Chapel Hill, and CALGB statisticians Drs. Donna Niedzwiecki, Donna Hollis, and Ebele Oraefo from Duke University Medical Center. For more information, please contact: Leslie Lang; Tel.: 919.843.9687 or Dianne Shaw; 919.966.7834.
This is an open-access article
Download PDF If the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.