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)

Abstract

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/m2 weekly x7, 1w rest and then weekly x3, q4w. Treatment continued until progression or for 6 months and could be resumed upon progression. The study was designed to detect an increase of median survival from 5 to 7 months. The survival analysis will be conducted after more than 80% of patients have died. An independent safety monitoring board is monitoring the trial data. Results: From June 2001 to June 2004, 319 pts with advanced disease from 30 institutions in 8 countries were randomized. 80% of all pts had metastatic disease, 67% had pain requiring pain medication and 84% had a KPS of 90 or 100 with a well-balanced distribution. Results on the primary and the secondary endpoints will be presented for both treatment groups during the meeting. Conclusions: To be reached after data becomes available. Supported in part by Hoffmann-La Roche and Eli Lilly Switzerland Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche Roche Lilly