title: [A phase II prospective randomized controlled trial of weekly paclitaxel combined with S-1 or fluorouracil for advanced gastric carcinoma].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of weekly paclitaxel combined with S-1 or fluorouracil in the first line treatment of advanced gastric carcinoma.
  
  
  METHODS
  Two hundred and forty patients with untreated advanced gastric carcinoma were randomized into two arms, patients in the experimental arm were given paclitaxel and S-1, while those in the control arm received paclitaxel and fluorouracil. The regimen of experimental arm was paclitaxel 60 mg/m(2) by intravenous infusion, day 1, 8, 15; S-1 80 - 120 mg/day given by oral administration, day 1 - 14. The regimen of control arm was fluorouracil 500 mg/m(2) by intravenous infusion continuously, day 1 - 5; CF 20 mg/m(2) by intravenous infusion, day 1 - 5. The regimens in both arms were repeated every 28 days. The efficacy and safety of both arms were assessed.
  
  
  RESULTS
  Two hundred and twenty-eight patients were analyzed in the full analysis set, and 192 patients were analyzed in per-protocol set (experimental arm 100 patients, control arm 92 patients). The overall response rates of experimental and control arms were 50.0% and 28.3% (P = 0.002), and the disease control rates were 82.0% and 70.7% (P = 0.064), respectively. The primary endpoints of experimental arm were non-inferior to that of the control arm. The secondary endpoint of experimental arm in terms of median progression free survival was significantly better than that of control arm (5 months versus 4 months, P = 0.006). The experimental arm had a higher incidence of grade III-IV bone marrow suppression than the control arm, but the incidence of fever in both arms was not significantly different.
  
  
  CONCLUSIONS
  Oral administration of S-1 is an alternative option of venous infusional fluorouracil. Weekly paclitaxel combined with S-1 is a safe regimen and has a promising efficacy.
authors.affiliation: Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital, Tianjin, China.
authors.forename: Ding-zhi
authors.initials: DZ
authors.lastname: Huang
authors.forename: Jian-ping
authors.initials: JP
authors.lastname: Xiong
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.forename: Zhao
authors.initials: Z
authors.lastname: Yan
authors.forename: Zhi-xiang
authors.initials: ZX
authors.lastname: Zhuang
authors.forename: Zhuang
authors.initials: Z
authors.lastname: Yu
authors.forename: Hui-ping
authors.initials: HP
authors.lastname: Wan
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhang
authors.forename: Ting
authors.initials: T
authors.lastname: Deng
authors.forename: Rong-sheng
authors.initials: RS
authors.lastname: Zheng
authors.forename: Zeng-qing
authors.initials: ZQ
authors.lastname: Guo
authors.forename: Chun-hong
authors.initials: CH
authors.lastname: Hu
authors.forename: Mei-Ling
authors.initials: ML
authors.lastname: Wang
authors.forename: Zhong-He
authors.initials: ZH
authors.lastname: Yu
authors.forename: Yang
authors.initials: Y
authors.lastname: Yao
authors.forename: Ji-chang
authors.initials: JC
authors.lastname: Meng
authors.forename: Yi
authors.initials: Y
authors.lastname: Ba
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D005472:Fluorouracil