Benefit only seen after adjusting for prognostic variables, not in primary analysis
TUESDAY, July 10 (HealthDay News) -- After adjusting for prognostic variables, patients who receive adjuvant chemotherapy following resection of periampullary adenocarcinomas have improved survival compared with those who receive only observation, according to a study published in the July 11 issue of the Journal of the American Medical Association.
To investigate whether adjuvant chemotherapy improves overall survival following resection, John P. Neoptolemos, M.D., from the University of Liverpool in the United Kingdom, and colleagues conducted an open-label, phase 3, randomized controlled trial from July 2000 to May 2008 in 100 centers in Europe, Australia, Japan, and Canada involving 498 patients with periampullary adenocarcinomas. Of these, 297 had ampullary, 96 had bile duct, and 35 had other cancers. Participants were randomized to an observation group (144 patients), to receive folinic acid plus fluorouracil (143 patients), or to receive gemcitabine (141 patients).
The researchers found that 61, 58, and 52 percent of patients in the observation, fluorouracil plus folinic acid, and gemcitabine groups died. Median survival was 35.2 months in the observation group, compared with 43.1 months in the two chemotherapy groups (hazard ratio, 0.86; P = 0.25). Compared with observation, the hazard ratio for chemotherapy was 0.75 (P = 0.03) after adjustment for independent prognostic variables of age, bile duct cancer, poor tumor differentiation, and positive lymph nodes.
"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," the authors write.