title: Safety analysis of weekly paclitaxel plus S-1 versus paclitaxel plus 5-fluorouracil/calcium folinate as first-line therapy in advanced gastric cancer: a multicenter open random phase II trial.
abstract: OBJECTIVE
  To report the results of a safety analysis from a phase II trial comparing administration of weekly paclitaxel plus S-1 (TS) versus paclitaxel plus 5-fluorouracil (5-FU)/calcium folinate (LV) (TLF) as first-line therapy for advanced gastric cancer.
  
  
  METHODS
  Patients (n = 240) with previously untreated advanced gastric cancer were randomly assigned to receive either TS or TLF in a 28-day cycle for six cycles.
  
  
  RESULTS
  The clinical features of both sets of patients were similar, with the exception of the incidence of  prior chemotherapy (P>0·05). Most treatment-related adverse events occurred at similar rates in both treatment arms. However, patients receiving TS experienced an increase in all-grade especially grade 3/4 neutropenia, with an incidence of 43·7% in the TS arm and 16·3%  in the TLF arm, respectively (P<0·05). Other severe adverse events were infrequent and not significantly different between the groups.
  
  
  CONCLUSIONS
  The safety and tolerance of weekly paclitaxel plus S-1 or 5-FU/LV is well in untreated advanced gastric cancer patients.
authors: Department of Gastrointestinal Medical Oncology,Tianjin Medical University Cancer Institute and Hospital, Key Laboratory of Cancer Cancer Prevention and Therapy of Tianjin, China.
authors: Ting
authors: T
authors: Deng
authors: Nong
authors: N
authors: Xu
authors: Jian-Ping
authors: JP
authors: Xiong
authors: Zhao
authors: Z
authors: Yan
authors: Zhi-Xiang
authors: ZX
authors: Zhuang
authors: Zhuang
authors: Z
authors: Yu
authors: Hui-Ping
authors: HP
authors: Wan
authors: Yang
authors: Y
authors: Zhang
authors: Ding-Zhi
authors: DZ
authors: Huang
authors: Rong-Sheng
authors: RS
authors: Zheng
authors: Zeng-Qing
authors: ZQ
authors: Guo
authors: Chun-Hong
authors: CH
authors: Hu
authors: Mei-Ling
authors: ML
authors: Wang
authors: Zhong-He
authors: ZH
authors: Yu
authors: Yang
authors: Y
authors: Yao
authors: Ji-Chang
authors: JC
authors: Meng
authors: Yi
authors: Y
authors: Ba
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D002955:Leucovorin; D005472:Fluorouracil