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Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer. | LitMetric

AI Article Synopsis

  • The study aimed to assess the effectiveness and safety of combining gemcitabine and S-1 (GS) for treating unresectable pancreatic cancer.
  • Patients were randomly assigned to either the GS regimen or gemcitabine alone, with progression-free survival (PFS) being the main measure of success.
  • Results showed that GS significantly improved PFS and objective response rates compared to gemcitabine alone, though it also led to higher instances of severe side effects like neutropenia and thrombocytopenia.

Article Abstract

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.

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Source
http://dx.doi.org/10.1007/s00280-013-2368-6DOI Listing

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