title: Interim analysis of a phase II trial of cyclophosphamide, epirubicin and 5-fluorouracil (CEF) followed by docetaxel as preoperative chemotherapy for early stage breast carcinoma.
abstract: OBJECTIVE
  A single-arm phase II multicenter trial of the combination of cyclophosphamide (C), epirubicin (E), and 5-fluorouracil (F) followed by docetaxel as neoadjuvant chemotherapy is being conducted by the Japan Breast Cancer Research Group. This report describes an interim analysis of the clinical response and safety of 79 patients who finished preoperative chemotherapy and surgery.
  
  
  METHODS
  Patients with operable breast cancer received C at 500 mg/m2, E at 100 mg/m2, and F at 500 mg/m2 every 21 days for 4 cycles followed by docetaxel at 75 mg/m2 every 21 days for 4 cycles.
  
  
  RESULTS
  Of the 79 patients evaluable for analysis the median age was 46 years (28-59), and 61 patients (77.2%) had T2 tumors. A total of 312 of 316 (98.7%) cycles of CEF and 296 of 312 (94.9%) cycles of docetaxel were administered. Average total cumulative dose was 92% and 95% for CEF and docetaxel, respectively. The rate and grade of edema, neuropathy, arthralgia and myalgia were higher with docetaxel than with CEF. The overall clinical response rate was 70.9%. Breast conserving surgery was performed in 31 of 42 patients (73.8%) with a base-line tumor size of more than 3 cm.
  
  
  CONCLUSIONS
  Interim data suggest that CEF followed by docetaxel is an active and tolerable neoadjuvant chemotherapy regimen. A final analysis is planned for 2005.
authors.affiliation: Aichi Cancer Center Hospital Breast Surgery 464-8681, 1-1 Kanokoden Chikusa-ku, Nagoya, Japan.
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Seigo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
authors.forename: Eisei
authors.initials: E
authors.lastname: Shin
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Shinji
authors.initials: S
authors.lastname: Ohno
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: Kazufumi
authors.initials: K
authors.lastname: Hisamatsu
authors.forename: Kosuke
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Mikihiro
authors.initials: M
authors.lastname: Kusama
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kaise
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Sato
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Kuroi
authors.forename: Futoshi
authors.initials: F
authors.lastname: Akiyama
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Tsuda
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kurosumi
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D015412:Mastectomy, Segmental / Q000706:statistics & numerical data; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil