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.
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).
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.
MDLinx connects healthcare professionals and patients to tomorrow's important medical news, while providing the pharmaceutical and healthcare industries with highly targeted interactive marketing, education, content, and medical research solutions.