title: A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Nakai
authors.forename: H
authors.initials: H
authors.lastname: Isayama
authors.forename: T
authors.initials: T
authors.lastname: Sasaki
authors.forename: N
authors.initials: N
authors.lastname: Sasahira
authors.forename: T
authors.initials: T
authors.lastname: Tsujino
authors.forename: N
authors.initials: N
authors.lastname: Toda
authors.forename: H
authors.initials: H
authors.lastname: Kogure
authors.forename: S
authors.initials: S
authors.lastname: Matsubara
authors.forename: Y
authors.initials: Y
authors.lastname: Ito
authors.forename: O
authors.initials: O
authors.lastname: Togawa
authors.forename: T
authors.initials: T
authors.lastname: Arizumi
authors.forename: K
authors.initials: K
authors.lastname: Hirano
authors.forename: M
authors.initials: M
authors.lastname: Tada
authors.forename: M
authors.initials: M
authors.lastname: Omata
authors.forename: K
authors.initials: K
authors.lastname: Koike
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage*; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage*; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine