PURPOSE: 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. METHODS: Patients were randomly assigned to receive GS (oral S-1 60 mg/m(2) daily on days 1-15 every 3 weeks and gemcitabine 1,000 mg/m(2) on days 8 and 15) or gemcitabine (1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). RESULTS: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 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P = 0.048). Median survival was 8.6 months for GS and 8.6 months 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. CONCLUSIONS:GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.
RCT Entities:
PURPOSE: 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. METHODS:Patients were randomly assigned to receive GS (oral S-1 60 mg/m(2) daily on days 1-15 every 3 weeks and gemcitabine 1,000 mg/m(2) on days 8 and 15) or gemcitabine (1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). RESULTS: 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 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P = 0.048). Median survival was 8.6 months for GS and 8.6 months 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. CONCLUSIONS:GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.
Authors: Philipp Horvath; Stefan Beckert; Florian Struller; Alfred Königsrainer; Marc André Reymond Journal: Clin Exp Metastasis Date: 2018-07-30 Impact factor: 5.150
Authors: Martin Graversen; Sönke Detlefsen; Jon Kroll Bjerregaard; Per Pfeiffer; Michael Bau Mortensen Journal: Clin Exp Metastasis Date: 2017-05-17 Impact factor: 5.150
Authors: Y Takei; S Okamoto; K Kawamura; Y Jiang; T Morinaga; M Shingyoji; I Sekine; S Kubo; Y Tada; K Tatsumi; H Shimada; K Hiroshima; N Yamaguchi; M Tagawa Journal: Cancer Gene Ther Date: 2015-08-07 Impact factor: 5.987