title: Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer.
abstract: OBJECTIVE
  The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer.
  
  
  METHODS
  Patients were randomly assigned to receive GS (oral S-1 60 mg/m(2) daily on days 1-15 every 3 weeks and gemcitabine 1,000 mg/m(2) on days 8 and 15) or gemcitabine (1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS).
  
  
  RESULTS
  One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43-0.98; P = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61-1.41; P = 0.714). Grade 3-4 neutropenia (44 vs 19.6 %, P = 0.011) and thrombocytopenia (26 vs 8.7 %, P = 0.051) were more frequent in the GS arm.
  
  
  CONCLUSIONS
  GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.
authors: Department of Gastroenterology, Chiba Cancer Center, 666-2 Nitona-cho, Chuo-ku, Chiba, 260-8717, Japan, kentarosudo9@yahoo.co.jp.
authors: Kentaro
authors: K
authors: Sudo
authors: Takeshi
authors: T
authors: Ishihara
authors: Nobuto
authors: N
authors: Hirata
authors: Fumiaki
authors: F
authors: Ozawa
authors: Tadashi
authors: T
authors: Ohshima
authors: Ryosaku
authors: R
authors: Azemoto
authors: Kenji
authors: K
authors: Shimura
authors: Takeshi
authors: T
authors: Nihei
authors: Takayoshi
authors: T
authors: Nishino
authors: Akihiko
authors: A
authors: Nakagawa
authors: Kazuyoshi
authors: K
authors: Nakamura
authors: Taro
authors: T
authors: Hara
authors: Motohisa
authors: M
authors: Tada
authors: Rintaro
authors: R
authors: Mikata
authors: Katsunobu
authors: K
authors: Tawada
authors: Osamu
authors: O
authors: Yokosuka
authors: So
authors: S
authors: Nakaji
authors: Taketo
authors: T
authors: Yamaguchi
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine