CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC)

Abstract

LBA4504 Background: Prognosis of patients (pts) with PC is dismal, even after curatively intended resection. Whereas gemcitabine-based chemotherapy is standard in advanced PC, the role of adjuvant chemotherapy is still under discussion. Methods: CONKO-001, a prospective, open, multicenter, controlled phase 3 study was designed to evaluate the efficacy and toxicity of gemcitabine in PC pts after complete (R0 or R1) resection. After stratification for R0/R1, nodal tumour involvement and tumour stage pts were randomized to receive either gemcitabine (G) (1g/m2 d 1, 8 and 15 every 4 weeks) for 6 months or observation (O). Pts in the observation group received no specific anticancer treatment. Primary study endpoint was disease free survival (DFS), secondary endpoints included OS and toxicity. The study was powered to detect a significant difference in DFS with 90% probability at a significance level of .05 on all eligible patients. Results: Between July 1998 and December 2004 368 pts were randomized and 354 w...