title: Update results of FEC followed by docetaxel neoadjuvant trials for primary breast cancer.
abstract: This study has been initiated to evaluate the safety, clinical and pathologic response as well as the relation of response (pCR or non-pCR) and survival (overall and relapse-free) of fluorouracil, epirubicin and cyclophosphamide (FEC) followed by docetaxel (DOC) as preoperative chemotherapy in patients with operable breast cancer. Japanese patients with primary breast cancer, Tlc-3N0M0 or T1-3NIM0, age 20-60, PS 0-1 were included in this study. Preoperative chemotherapy consisted of 4 cycles of FEC (500 mg/m(2), 100 mg/m(2), 500 mg/m(2)) every 3 weeks followed by 4 cycles of DOC (75 mg/m(2)) every 3 weeks. Since June 2002, 200 patients were enrolled in this study, and the time of this interim analysis, 80 patients were evaluable for safety and clinical efficacy. The overall clinical response rate was 71.4% (14% CR, 44% PR, 42% SD/PD), and the only G3,4 toxicities, neutropenia and febrile neutropenia were observed in 54% and 14% of patients, respectively. Eighty nine patients were evaluable for pathologic response by central review. Pathologic response was evaluated among invasive tumors on multiple cross-section specimens based on a modified version of the Japanese grading system for Japanese Breast Cancer Society. The pathologic response rate was 17%. In this ongoing trial, FEC followed by DOC was active and well tolerated.
authors.affiliation: Japan Breast Cancer Research Group, c/o Komagome Hospital, Bunkyo-ku, Tokyo, Japan. kujwbae@unitel.co.kr
authors.forename: S
authors.initials: S
authors.lastname: Ohnoa
authors.forename: M
authors.initials: M
authors.lastname: Toi
authors.forename: K
authors.initials: K
authors.lastname: Kuroi
authors.forename: S
authors.initials: S
authors.lastname: Nakamura
authors.forename: H
authors.initials: H
authors.lastname: Iwata
authors.forename: M
authors.initials: M
authors.lastname: Kusama
authors.forename: N
authors.initials: N
authors.lastname: Masuda
authors.forename: K
authors.initials: K
authors.lastname: Yamazaki
authors.forename: K
authors.initials: K
authors.lastname: Hisamatsu
authors.forename: Y
authors.initials: Y
authors.lastname: Sato
authors.forename: Y
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: E
authors.initials: E
authors.lastname: Shin
authors.forename: H
authors.initials: H
authors.lastname: Kaise
authors.forename: M
authors.initials: M
authors.lastname: Kurozumi
authors.forename: H
authors.initials: H
authors.lastname: Tsuda
authors.forename: F
authors.initials: F
authors.lastname: Akiyama
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D000077143:Docetaxel; D023381:Endpoint Determination; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D013534:Survival; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil