Adjuvant chemotherapy administered after surgery for cancers near the pancreas confers a modest but statistically significant survival benefit after adjustments are made for prognostic variables, a recent study indicates.
Although adjuvant chemotherapy has been shown to increase survival following resectional surgery for pancreatic cancer, no randomized trials assessing such treatment in patients with resected periampullary adenocarcinomas had been done until the current study, according to investigators John P. Neoptolemos, MD, of the University of Liverpool, England, and colleagues (JAMA. 2012;308:147-156). Periampullary cancers form near the ampulla of Vater (an enlargement of the ducts from the liver and the pancreas where they join and enter the small intestine).
This research project involved 297 participants with ampullary cancer, 96 with cancer of the bile duct, and 35 with other periampullary cancers. One set of 143 patients had been randomized to receive 20 mg/m2 of folinic acid by means of IV bolus injection followed by 425 mg/m2 of fluorouracil by means of IV bolus injection administered 1 to 5 days every 28 days. Another group of 141 patients received 1,000 mg/m2 of IV infusion gemcitabine once a week for 3 of every 4 weeks for 6 months. An additional 144 patients comprised the observation group.
A total of 88 patients (61%) in the observation group died, compared with 83 (58%) in the fluorouracil-plus-folinic-acid group and 73 (52%) in the gemcitabine group. Median survival was 35.2 months in the observation group, compared with 43.1 months in each of the chemotherapy groups.
The unadjusted primary analysis of the primary outcome of survival did not demonstrate a significant benefit for adjuvant chemotherapy. However, a statistically significant survival benefit for chemotherapy emerged when data were adjusted for the independent prognostic variables of patient age, presence of bile duct cancer, poor tumor differentiation, and positive lymph nodes. Compared with observation, the hazard ratio for chemotherapy was 0.75 after the researchers adjusted for those variables.