title: Biweekly docetaxel, cisplatin, and 5-fluorouracil (DCF) chemotherapy for advanced esophageal squamous cell carcinoma: a phase I dose-escalation study.
abstract: OBJECTIVE
  The optimal chemotherapeutic protocol for the treatment of esophageal cancer has not yet been established. A dose-escalation study of docetaxel combined with cisplatin and 5-fluorouracil (5-FU) was performed to determine the optimal dose in patients with advanced esophageal squamous cell carcinoma.
  
  
  METHODS
  We studied a total of 18 patients who had previously untreated thoracic esophageal squamous cell carcinoma with T4 tumors and/or metastasis. The patients received an infusion of docetaxel at different dose levels (levels 1, 2, 3: 30, 35, 40 mg/m(2), respectively) and an infusion of cisplatin (40 mg/m(2)) on days 1 and 15 plus a continuous infusion of 5-FU (400 mg/m(2)/day) on days 1-5 and 15-19.
  
  
  RESULTS
  Dose-limiting toxicities (DLT) included febrile neutropenia and leukopenia. DLT occurred in 2 of 6 patients at level 1, 2 and in 3 of 6 patients at level 3. The response rate was 88.9%, including a complete response rate of 33.3%.
  
  
  CONCLUSIONS
  To minimize toxicity and maximize dose intensity, we elected to investigate a biweekly regimen. The maximum tolerated dose was level 3, and the recommended dose was determined to be docetaxel 35 mg/m(2) with cisplatin 40 mg/m(2) plus 5-FU 400 mg/m(2), administered biweekly. This regimen was tolerable and highly active. A phase II study has been started.
authors.affiliation: Department of Surgical Oncology, Gifu Graduate School of Medicine, 1-1, Yanagido, Gifu city, Gifu 501-1194, Japan. yoshihirotana11@hotmail.com
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Sanada
authors.forename: Shinji
authors.initials: S
authors.lastname: Osada
authors.forename: Kazuya
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Takao
authors.initials: T
authors.lastname: Takahashi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil