Adjuvant Chemotherapy With Fluorouracil Plus Folinic Acid vs Gemcitabine Following Pancreatic Cancer Resection

作者：John P. Neoptolemos, Deborah D. Stocken, Claudio Bassi, Paula Ghaneh, David Cunningham, David B Goldstein, Robert Padbury, Malcolm J. Moore, Steven N. Gallinger, C. Mariette, Moritz N. Wente, Jakob Robert Izbicki, Helmut Friess, Markus M. Lerch, Christos Dervenis, Attila Oláh, Giovanni Butturini, Ryuichiro Doi, Pehr Lind, David B. Smith, Juan W. Valle, Daniel H. Palmer, John A. C. Buckels, Joyce Thompson, Colin J. McKay, Charlotte Louise Rawcliffe, Markus Wolfgang Büchler, for the European Study Group for Pancreatic Cancer · 发表于：JAMA · 年份：2010 · DOI：10.1001/jama.2010.1275 · 被引用次数：1402 · 研究领域：Pancreatic and Hepatic Oncology Research、Cholangiocarcinoma and Gallbladder Cancer Studies、Cancer Research and Treatments

CONTEXT: Adjuvant fluorouracil has been shown to be of benefit for patients with resected pancreatic cancer. Gemcitabine is known to be the most effective agent in advanced disease as well as an effective agent in patients with resected pancreatic cancer. OBJECTIVE: To determine whether fluorouracil or gemcitabine is superior in terms of overall survival as adjuvant treatment following resection of pancreatic cancer. DESIGN, SETTING, AND PATIENTS: The European Study Group for Pancreatic Cancer (ESPAC)-3 trial, an open-label, phase 3, randomized controlled trial conducted in 159 pancreatic cancer centers in Europe, Australasia, Japan, and Canada. Included in ESPAC-3 version 2 were 1088 patients with pancreatic ductal adenocarcinoma who had undergone cancer resection; patients were randomized between July 2000 and January 2007 and underwent at least 2 years of follow-up. INTERVENTIONS: Patients received either fluorouracil plus folinic acid (folinic acid, 20 mg/m(2), intravenous bolus injection, followed by fluorouracil, 425 mg/m(2) intravenous bolus injection given 1-5 days every 28 days) (n = 551) or gemcitabine (1000 mg/m(2) intravenous infusion once a week for 3 of every 4 weeks) (n = 537) for 6 months. MAIN OUTCOME MEASURES: Primary outcome measure was overall survival; secondary measures were toxicity, progression-free survival, and quality of life. RESULTS: Final analysis was carried out on an intention-to-treat basis after a median of 34.2 (interquartile range, 27.1-43....