title: Neoadjuvant chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil for esophageal cancer.
abstract: OBJECTIVE
  We aimed to evaluate the safety, tolerability, and efficacy of combination preoperative chemoradiotherapy as first-line treatment in patients with advanced esophageal cancer.
  
  
  METHODS
  We performed a phase I dose-escalation trial of docetaxel at 25-40 mg/m(2) in four planned dose levels in 3-6 patient cohorts on days 1, 15, 29, and 43 administered in combination with cisplatin (70 mg/m(2) on days 1 and 29) and 5-fluorouracil (70 mg/m(2)/day on days 1-4 and 29-32) and concurrent radiation therapy (40 Gy). The tumors were resected during weeks 10-13.
  
  
  RESULTS
  This study included 7 patients with esophageal cancer. The dose-limiting toxicity was observed at a biweekly docetaxel dose of 30 mg/m(2) when patients developed grade 3 febrile neutropenia, grade 4 thrombocytopenia, and grade 4 pain/esophagus, resulting in a maximum tolerated dose of 25 mg/m(2). Grade 3/4 hematological toxicity was observed in 71% of the patients and grade 3/4 non-hematological toxicity in 57%. The overall tumor response rate was 86% (complete, 57% and partial, 29%). All patients underwent surgery, and there were no deaths as a result of postoperative complications.
  
  
  CONCLUSIONS
  This preoperative chemoradiotherapy regimen using triplets is feasible but results in moderate toxicity. It is noteworthy that this regimen was associated with a high rate of pathological complete remission.
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8553, Japan. moaista@wish.ocn.ne.jp
authors.forename: Manabu
authors.initials: M
authors.lastname: Emi
authors.forename: Jun
authors.initials: J
authors.lastname: Hihara
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Hamai
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Aoki
authors.forename: Morihito
authors.initials: M
authors.lastname: Okada
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kenjo
authors.forename: Yuji
authors.initials: Y
authors.lastname: Murakami
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil