التفاصيل البيبلوغرافية
العنوان: |
A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study. |
المؤلفون: |
Nakai, Y, Isayama, H, Sasaki, T, Sasahira, N, Tsujino, T, Toda, N, Kogure, H, Matsubara, S, Ito, Y, Togawa, O, Arizumi, T, Hirano, K, Tada, M, Omata, M, Koike, K |
المصدر: |
British Journal of Cancer; 6/5/2012, Vol. 106 Issue 12, p1934-1939, 6p, 2 Diagrams, 3 Charts, 2 Graphs |
مصطلحات موضوعية: |
CANCER research, PANCREATIC cancer treatment, NUCLEOSIDES, PANCREATIC cancer, CANCER patients, CANCER invasiveness, RANDOMIZED controlled trials, THERAPEUTICS |
مستخلص: |
Background:This randomised phase II trial compared gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer.Methods:Patients were randomly assigned to 4-week treatment with gemcitabine alone (1000, mg m−2 gemcitabine by 30-min infusion on days 1, 8, and 15) or gemcitabine and S-1 combination therapy (1000, mg m−2 gemcitabine by 30-min infusion on days 1 and 15 and 40 mg m−2 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.Conclusion: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. [ABSTRACT FROM AUTHOR] |
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قاعدة البيانات: |
Complementary Index |