GemOx (Gemcitabine + Oxaliplatin) versus Gem (Gemcitabine) in non resectable pancreatic adenocarcinoma : final results of the GERCOR /GISCAD Intergroup Phase III

Abstract

4008 Background: The combination of gemcitabine 1 g/m2 as a 100 min infusion (10 mg/m2/mn) D1 and oxaliplatin 100 mg/m2 in 2h infusion D2 (GemOx) every two weeks showed interesting results in a multicenter phase II study (Louvet et al, JCO 2002) and was thus further explored in a phase III randomised study. Methods: Patients were stratified according to center, performance status and type of disease (locally-advanced (LA) versus metastatic (M)) and were randomly assigned to GemOx or standard treatment with gemcitabine alone (1 g/m2 in a 30 min infusion weekly). 300 patients were needed to demonstrate an absolute improvement of 20% in 8-month survival (30% to 50%). Results: 326 patients have been enrolled; 13 were non eligible, 156 were allocated to Gem arm and 157 to GemOx. Preliminary results presented last year (Louvet, ASCO 2003) were actualized and confirm a significant improvement for the GemOx arm in response rate (28.7% vs 16.7%, p = 0.02), median progression free survival (5.5 months vs 3.7, p = 0.04), and clinical benefit (38.9% vs 29.2%, p = 0.05), with a good tolerability of the GemOx combination. Final analysis (March 04) has shown median overall survival of 7.1 months (Gem) and of 9.0 months (Gemox), respectively (p = 0.13, HR 1.20 [.95 - 1.54]). The 8-month survival probability was 45% in the Gem arm and 56% in the Gemox arm. For LA pts (30% of total enrolled), median survivals were identical (10.3 months) in both arm, while for M pts (70%), median survival was 6.7 months (Gem) arm and 8.5 months (Gemox), respectively (p = 0.17; HR 1.21 [.91 - 1.63]. A second-line chemotherapy was administered in 53.4% of the Gem pts (mainly platin-based) and in 52.3% of the Gemox pts (miscellaneous). Conclusion: Gemox achieved significantly better results than Gem in terms of RR, clinical benefit and PFS, but the difference did not reach the significant level for OS. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi-Synthelabo Sanofi-Synthelabo