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...
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