CONKO-005: Adjuvant therapy in R0 resected pancreatic cancer patients with gemcitabine plus erlotinib versus gemcitabine for 24 weeks—A prospective randomized phase III study.

4007 Background: Adjuvant chemotherapy with gemcitabine (Gem) for 6 months significantly improves survival of pancreatic cancer patients. CONKO-005 was designed to evaluate an additional effect of the EGFR-tyrosinkinase-inhibitor erlotinib (Erlo 100 mg p.o. daily) in combination with Gem (1000 mg/m² i.v. day 1,8,15, q29) for 24 weeks in pts after R0 resection. Methods: In an open-label multicenter design, pts were randomised within 8 weeks after operation to receive GemErlo or Gem; stratified by lymph node involvement, operation techniques, study centre. The primary endpoint was disease-free survival (DFS). The study was planned with a power of 80% at a significance level of 0.05 to detect an improvement of DFS from 14 to 18 months. Secondary objectives were median overall survival (OS) and treatment safety. Kaplan-Meier analyses were performed; survival data for the treatment arms compared using log-rank test. RESULTS: Between April 2008 and July 2013, 219 pts were randomized to GemErlo and 217 to Gem. P...