title: Multicenter phase I/II study of docetaxel, cisplatin and fluorouracil combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the esophagus.
abstract: OBJECTIVE
  Esophageal squamous cell carcinoma (ESCC) is refractory to current therapeutic regimens and more effective therapies are imperative. To this end, we conducted a multicenter phase I/II trial of docetaxel, cisplatin, and fluorouracil (DCF) combination chemotherapy for ESCC.
  
  
  METHODS
  The study subjects were 46 patients with advanced or recurrent ESCC. Treatment included docetaxel at 60, 70, and 75 mg/m(2), cisplatin at 70 mg/m(2) on day 1, and daily fluorouracil at 700 mg/m(2) on days 1 through 5. The recommended dose of docetaxel was determined in phase I, while the response rate (RR) and progression-free survival rates were analyzed in phase II.
  
  
  RESULTS
  The recommended dose was determined to be 70 mg/m(2) in phase I. In phase II, the RR was 72.5%. Interim analysis showed median and 1-year progression-free survival of 14 months and 55.6%, respectively. Grade 3/4 toxicities of leukopenia and neutropenia occurred in 72.5 and 90% of patients, respectively. No treatment-related death was recorded. Surgical resection was subsequently performed in 20 patients after chemotherapy, and curative resection was achieved in 19.
  
  
  CONCLUSIONS
  DCF was tolerable and effective for advanced and recurrent ESCC. Such findings might encourage a change in the treatment strategy for ESCC.
authors.affiliation: Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2-E2 Yamadaoka, Suita, Osaka, Japan. myamasaki@gesurg.med.osaka-u.ac.jp
authors.forename: Makoto
authors.initials: M
authors.lastname: Yamasaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyata
authors.forename: Koji
authors.initials: K
authors.lastname: Tanaka
authors.forename: Osamu
authors.initials: O
authors.lastname: Shiraishi
authors.forename: Masaaki
authors.initials: M
authors.lastname: Motoori
authors.forename: Y F
authors.initials: YF
authors.lastname: Peng
authors.forename: Takushi
authors.initials: T
authors.lastname: Yasuda
authors.forename: Masahiko
authors.initials: M
authors.lastname: Yano
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Shiozaki
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil