CHICAGO – Patients who had surgery for periampullary cancer and received chemotherapy had a statistically significant survival benefit compared to those who did not receive chemotherapy, after adjusting for prognostic variables, according to a study published in JAMA.
Periampullary cancer is a variety of cancer types located in and near the head of the pancreas. The area includes the ampulla where the bile duct and the pancreatic duct join to empty into the small intestine. According to background information in the article, “The clinical presentation is similar to that of pancreatic ductal adenocarcinoma, and together they represent a major cause of death. Around 80 percent of periampullary adenocarcinomas are resectable and thus comprise around 30 percent to 40 percent of all resections for cancers in the head of the pancreas.”
Headed by John P. Neoptolemos, M.D., of the University of Liverpool, England, the study determined whether adjuvant chemotherapy (fluorouracil or gemcitabine) provides improved overall survival after resection. The randomized controlled trial from July 2000 to May 2008 was conducted in 100 centers in Europe, Canada, Australia, and Japan. A total of 428 patients were included in the primary analysis, with 144 assigned to the observation group. One hundred forty-three patients received folinic acid followed by fluorouracil, both via intravenous bolus injection, administered one to five days every 28 days, while 141 patients received intravenous gemcitabine infusion once a week for 3 of every 4 weeks for 6 months.
A total of 244 patients had died at the time of analysis. Median survival was 35.2 months for the observation group and 43.1 months for the chemotherapy group. The unadjusted primary analysis did not demonstrate a significant benefit for adjuvant chemotherapy. However, according to the study “[m]ultivariate analysis, correcting for prognostic variables, found a statistically significant survival benefit to chemotherapy and specifically for gemcitabine compared with observation, notwithstanding the better safety profile compared with fluorouracil plus folinic acid.
“Although this study found support for the use adjuvant chemotherapy to improve survival in patients with periampullary cancers, this effect was modest, indicating a need for further improvements and warranting the testing of combination chemotherapies.”
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