A randomised, prospective, multicenter, phase III trial of gemcitabine, 5-fluorouracil (5-FU), folinic acid vs. gemcitabine alone in patients with advanced pancreatic cancer

Abstract

LBA4009 Background: The combination of gemcitabine 1 g/m2 and 5-FU 750 mg/m2 as a continuous 24 h-infusion, modulated by folinic acid 200 mg/m2 given on d1, 8, 15, 22 every six weeks (GFF) showed interesting results in a multicenter phase II study (Oettle, Ann Oncol 2000). It was thus further explored in a phase III randomised study comparing it to gemcitabine standard therapy (G) (1 g/m2 weekly 7q8w, followed by 3q4w). Methods: Patients were randomised to receive GFF or G after stratification for disease extend and Karnofsky performance status (KPS). Eligibility criteria included KPS>= 60%, locally advanced or metastatic disease, no prior chemotherapy. Primary endpoint was median overall survival (mOS). Study was powered to detect a significant difference with 80% probability at a significance level of 0,05 when 392 death were observed. Secondary end-points include time to progression (TTP) and toxicity. Results: 473 pts. were randomised between 08/00 and 11/03. 235 pts. were allocated to GFF and 238 to G. Final analysis is scheduled for january 2005. Data on mOS, 1-year survival, TTP and toxicity will be presented. Statistics using Kaplan-Meier estimates and log-rank test for significance will be used for mOS and TTP. Conclusions: Will be reached after analysing the results. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly Oncology Lilly Oncology