Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs. observation on survival in patients with resected periampullary adenocarcinoma

The authors are to be congratulated on the successful design and completion of this study, which addresses an infrequently examined question in a relatively rare disease complex. Seeking to discover whether adjuvant chemotherapy contributes to survival following an R0 or R1 resection of periampullary adenocarcinoma, they randomized a total of 434 patients to one of three arms. 145 patients were observed, 146 received adjuvant gemcitabine given in standard fashion 2 out of 3 weeks per month, and 143 received 5-FU/leucovorin as per the Mayo regimen, both for 6 months. In terms of anatomic classification, 297 cases were ampullary, 96 bile duct and 35 “other” in origin. Specifically addressing ampullary tumors, pathologic subclassification indicated that 80 tumors were intestinal subtype, 46 pancreaticobiliary subtype, and 9 mixed, but fully 162 were indeterminate.