A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study

British Journal of Cancer, 05/08/2012

Nakai Y et al. – Gemcitabine and S-1 combination therapy demonstrated longer PFS in advanced pancreatic cancer. Improved OS duration of 4.7 months was found for gemcitabine and S-1 combination therapy, though this was not statistically significant.

Methods

  • Patients were randomly assigned to 4-week treatment with gemcitabine alone (1000, mgm2 gemcitabine by 30 min infusion on days 1, 8, and 15) or gemcitabine and S-1 combination therapy (1000, mgm2 gemcitabine by 30 min infusion on days 1 and 15 and 40 mgm2 S-1 orally twice daily on days 1–15).
  • The primary end point was progression-free survival (PFS).

Results

  • Between July 2006 and February 2009, 106 patients were enrolled. The PFS in gemcitabine and S-1 combination arm was significantly longer than in gemcitabine arm (5.4 vs 3.6 months), with a hazard ratio of 0.64 (P=0.036).
  • Overall survival (OS) for gemcitabine and S-1 combination was longer than that for gemcitabine monotherapy (13.5 vs 8.8 months), with a hazard ratio of 0.72 (P=0.104).
  • Overall, grade 3 or 4 adverse events were similar in both arms.

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