title: Randomized multicenter phase III study of a modified docetaxel and cisplatin plus fluorouracil regimen compared with cisplatin and fluorouracil as first-line therapy for advanced or locally recurrent gastric cancer.
abstract: BACKGROUND
  The V325 study showed that docetaxel, cisplatin, and fluorouracil (DCF) prolonged overall survival (OS) of patients with advanced gastric cancer, but with a high incidence of dose-limiting toxicities. We investigated the efficacy and safety of a modified DCF (mDCF) regimen for Chinese patients with advanced gastric cancer.
  
  
  METHODS
  Untreated advanced gastric cancer patients randomly received docetaxel and cisplatin at 60 mg/m(2) (day 1) followed by fluorouracil at 600 mg/m(2)/day (days 1-5; mDCF regimen) or cisplatin at 75 mg/m(2) (day 1) followed by fluorouracil at 600 mg/m(2)/day (days 1-5; CF) every 3 weeks. The primary end point was progression-free survival (PFS). The secondary end points were OS, overall response rate (ORR), time-to-treatment failure (TTF), and safety.
  
  
  RESULTS
  In total, 243 patients were randomized to treatment (mDCF regimen 121; CF 122). Compared with CF, the mDCF regimen significantly improved PFS and OS: the median PFS was 7.2 and 4.9 months, respectively [hazard ratio (HR) 0.58, log-rank P = 0.0008], and the median OS was 10.2 and 8.5 months, respectively (HR = 0.71, P = 0.0319). Additionally, the mDCF regimen improved the parameters used as secondary objectives: the ORR was 48.7% with the mDCF regimen versus 33.9% with CF (P = 0.0244); the median TTF was 3.4 months with the mDCF regimen and 2.4 months with CF (HR = 0.67, P = 0.0027). Grade 3 and grade 4 treatment-related adverse events occurred in 77.3 % of patients who received the mDCF regimen versus 46.1% of patients who received CF (P < 0.001).
  
  
  CONCLUSIONS
  The mDCF regimen, compared with CF, significantly prolonged PFS and OS and enhanced ORR of Chinese patients with advanced gastric cancer. The mDCF regimen achieved efficacy comparable to that of DCF but with fewer toxicities, which is appropriate for the Chinese population.
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Jinwan
authors.initials: J
authors.lastname: Wang
authors.affiliation: Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Ruihua
authors.initials: R
authors.lastname: Xu
authors.affiliation: Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, No 52 Fu Cheng Road, Haidian District, Beijing, 100142, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Li
authors.affiliation: Harbin Medical University Cancer Hospital, Harbin, China.
authors.forename: Yuxian
authors.initials: Y
authors.lastname: Bai
authors.affiliation: Fudan University Affiliated Zhong Shan Hospital, Shanghai, China.
authors.forename: Tianshu
authors.initials: T
authors.lastname: Liu
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Shunchang
authors.initials: S
authors.lastname: Jiao
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Guanghai
authors.initials: G
authors.lastname: Dai
authors.affiliation: 307 Hospital of PLA, Beijing, China.
authors.forename: Jianming
authors.initials: J
authors.lastname: Xu
authors.affiliation: The First Hospital of China Medical University, Shenyang, China.
authors.forename: Yunpeng
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Fujian Provincial Cancer Hospital, Fuzhou, China.
authors.forename: Nanfeng
authors.initials: N
authors.lastname: Fan
authors.affiliation: Jiangsu Provincial Hospital, Nanjing, China.
authors.forename: Yongqian
authors.initials: Y
authors.lastname: Shu
authors.affiliation: Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Ba
authors.affiliation: Guangdong General Hospital, Guangzhou, China.
authors.forename: Dong
authors.initials: D
authors.lastname: Ma
authors.affiliation: PLA Cancer Center of Bayi Hospital, Nanjing, China.
authors.forename: Shukui
authors.initials: S
authors.lastname: Qin
authors.affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Leizhen
authors.initials: L
authors.lastname: Zheng
authors.affiliation: Suzhou University Affiliated First Hospital, Suzhou, China.
authors.forename: Weichang
authors.initials: W
authors.lastname: Chen
authors.affiliation: Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, No 52 Fu Cheng Road, Haidian District, Beijing, 100142, China. lin100@medmail.com.cn.
authors.forename: Lin
authors.initials: L
authors.lastname: Shen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Advanced gastric cancer; Modified docetaxel and cisplatin plus fluorouracil regimen; Overall survival; Progression-free survival; Safety