Gemcitabine (G) plus capecitabine (C) versus G alone in locally advanced or metastatic pancreatic cancer. A randomized phase III study of the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative Oncology Group (CECOG)

LBA4010 Background: While G is a widely accepted treatment for pts with advanced pancreatic cancer, C has shown single agent activity and promising efficacy in combination with G in phase II studies. Therefore, we compared the combination of G + C with G alone in a randomized phase III study. Methods: Major eligibility criteria: KPS ≥ 60, WBC ≥ 3.5 x 109/l, platelets ≥ 100 x 109/l, hemoglobin ≥ 10.0 g/dl, sufficient liver function (bilirubin/ASAT/ALAT/ alkaline phosphatase < 5 x upper normal limit), creatinine clearance ≥ 30 ml/min and no previous chemotherapy for metastatic disease. Stratification factors: locally advanced/metastatic disease, absence/presence of pain, institution, KPS 60–80/90–100. The primary endpoint is overall survival. Secondary endpoints are quality of life, clinical benefit response, objective tumor response, duration of response, time to progression and safety. Pts were randomized to receive G 1000 mg/m2 i.v. over 30’ d 1+8 and C 650 mg/m2 orally q12hrs d 1–14, q3w, or G 1000 mg/m...