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Recent studies showed that adjuvant chemotherapy with either 5-fluorouracil (5-FU) or gemcitabine conferred a survival benefit in patients with resected pancreatic cancer (JW Oncol Hematol Sep 21, 2010 and JW Oncol Hematol Jul 27, 2004). Will this approach also benefit patients with resected periampullary cancers?
To find out, investigators conducted an international phase III trial involving 434 patients with cancers of the ampulla, duodenum, and bile duct. Patients were randomized after R0 or R1 surgery to observation or adjuvant chemotherapy with either 6 months of fluorouracil (425 mg/m2) and leucovorin (20 mg/m2 on days 1 to 5 every 4 weeks) or gemcitabine (1000 mg/m2 weekly every 3 of 4 weeks). Most patients had ampullary tumors (65%–7…