Abstract
The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer. Patients were randomly assigned to receive GS (oral S-1 60mg/m(2) daily on days 1-15 every 3weeks and gemcitabine 1,000mg/m(2) on days 8 and 15) or gemcitabine (1,000mg/m(2) on days 1, 8, and 15 every 4weeks). The primary endpoint was progression-free survival (PFS). One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95% CI 0.43-0.98; P=0.039; median 5.3 vs 3.8months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6%, P=0.048). Median survival was 8.6months for GS and 8.6months for GEM (HR 0.93; 95% CI 0.61-1.41; P=0.714). Grade 3-4 neutropenia (44 vs 19.6%, P=0.011) and thrombocytopenia (26 vs 8.7%, P=0.051) were more frequent in the GS arm. GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.
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