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The Andrew L. Warshaw, MD, Institute for Pancreatic Cancer Research
New Standard for Metastatic Pancreatic Cancer Patients
At the Annual Meeting for the American Society of Clinical Oncology in June at new standard was set for the treatment of patients with metastatic pancreatic cancer. In a study by the ACCORD/PRODIGE group in France, patients with metastatic pancreatic cancer were randomized to either FOLFIRINOX or gemcitabine in a phase III study. FOLFIRINOX is a combination of 5-FU, oxaliplatin, and irinotecan and consists of the three most active agents against metastatic colon cancer. 342 pts were enrolled between 01/2005 and 10/2009. At the planned interim analysis, the Independent Data Monitoring Committee recommended to stop the study because the patients receiving FOLFIRINOX were doing so much better than the patients receiving gemcitabine. The confirmed response rates (reduction by diameter of tumor size by 30%) for FOLFIRINOX and gemcitabine were 27.6% and 10.9% (p = 0.0008). After a median follow-up was 19.5 months, the median progression free survival (PFS) was 6.4 vs. 3.4 m (p < 0.0001) for patients receiving FOLFIRINOX and gemcitabine, respectively. As of 09/2009, the median overall survival was 10.5 vs. 6.9 months (HR = 0.61; 95%CI = 0.46-0.81; p < 0.001).
The greatest concern in using this new regimen is safety. While it was clearly more toxic than gemcitabine, the quality of life for patients receiving FOLFIRINOX was better than for patients receiving gemcitabine which can be directly attributed to its antitumor activity. Interestingly, the majority of patients placed on the study had body and tail tumors and it will be important to see safety data in patients with pancreatic head tumors who are often dealing with biliary obstruction and cholangitis. Nevertheless, with an improvement in median overall survival of 4 months, FOLFIRINOX not only represents a new alternative for patients with pancreatic cancer, it should be the first choice for patients with metastatic pancreatic cancer in otherwise good health.
David P. Ryan, M.D. July 7, 2010
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