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
Yousuke NakaiKazuhiko Koike

Abstract

This randomised phase II trial compared gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer. 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). 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. 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.

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Citations

Aug 22, 2014·Cancer Chemotherapy and Pharmacology·Yousuke NakaiKazuhiko Koike
Mar 27, 2015·Expert Opinion on Investigational Drugs·Edward J KimRichard J Bold
Nov 16, 2014·Journal of Cancer Research and Clinical Oncology·Yousuke NakaiKazuhiko Koike
Aug 8, 2014·Frontiers in Oncology·Graeme F WoodworthHenry Brem
Apr 15, 2017·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Doug CoyleKelvin K W Chan
May 26, 2017·Japanese Journal of Clinical Oncology·Junji FuruseTadashi Ishii
Mar 21, 2018·The Cochrane Database of Systematic Reviews·Venessa ChinDesmond Yip
Jun 13, 2017·Cancer Research and Treatment : Official Journal of Korean Cancer Association·Jeffrey S ChangHui-Ju Ch'ang
Mar 1, 2014·The Cochrane Database of Systematic Reviews·Kurinchi Selvan GurusamyGiuseppe Fusai
Feb 2, 2018·Cancer Chemotherapy and Pharmacology·Stine Braendegaard WintherPer Pfeiffer
Aug 28, 2013·Cancer Chemotherapy and Pharmacology·Hunho SongDae Young Zang
Oct 15, 2013·Cancer Chemotherapy and Pharmacology·Yousuke NakaiKazuhiko Koike
Jun 14, 2014·Journal of Hepato-biliary-pancreatic Sciences·Hiroaki YanagimotoHiroyuki Isayama
Mar 12, 2016·Pancreas·Daisuke HashimotoHideo Baba
Jan 19, 2016·Respirology : Official Journal of the Asian Pacific Society of Respirology·Tsuyoshi HamadaKazuhiko Koike
Jan 31, 2015·Pancreas·Naminatsu TakaharaKazuhiko Koike
Nov 12, 2014·World Journal of Gastroenterology : WJG·Kentaro SudoTaketo Yamaguchi
Sep 22, 2019·International Journal of Molecular Sciences·Maximilian BrunnerGeorg F Weber

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