A randomized phase II trial of adjuvant chemotherapy with uracil/tegafur and gemcitabine versus gemcitabine alone in patients with resected pancreatic cancer

Abstract

BACKGROUND. There have been few randomized studies of adjuvant chemotherapy using gemcitabine (GEM) in patients with resected pancreatic cancer. METHODS. Patients with invasive ductal pancreatic cancer who underwent radical surgery were enrolled and assigned to receive uracil/tegafur (UFT) and GEM together (GU) or GEM alone (G). GEM was administrated at a dosage of 1 g/m² intravenously weekly 3 of 4 weeks and UFT at a dosage of 200 mg/day orally continuously. Eligibility included resection status 0 or 1, and no previous chemo‐ or/and radiation therapy. The primary endpoint was disease‐free survival (DFS), and secondary endpoints included overall survival (OS) and toxicity. RESULTS. Between 2002 and 2005, 100 patients were randomized into the 2 arms of the trial (50 patients to GU and 50 to G). One patient in the G group was found to be ineligible. Baseline characteristics were well balanced between the 2 groups. With a median observation period of 21 months, the 1‐ and 3‐year DFS rates were 50.0% and 17.7% in the GU group and 49.0% and 21.6% in the G group, respectively. The median OS was 21.2 months in the GU group and 29.8 months in the G group. Toxicity was minor and acceptable, less than grade 4 in both groups. CONCLUSIONS. Postoperative GEM‐based adjuvant chemotherapy was safe and well tolerated. However, addition of UFT with GEM did not improve DFS as compared with GEM alone. Further clinical trial resources for adjuvant chemotherapy should address other combinations and novel agents. Cancer 2008. © 2008 American Cancer Society.