title: Phase II trial in Japan of sequential administration of weekly paclitaxel followed by FEC as neoadjuvant chemotherapy for locally advanced breast cancer [KBCSG0206 trial: Kinki Breast Cancer Study Group (KBCSG)].
abstract: OBJECTIVE
  We conducted a phase II trial in Japan to evaluate the efficacy and tolerability of weekly paclitaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) as neoadjuvant chemotherapy (NAC) for locally advanced breast cancer (LABC).
  
  
  METHODS
  Patients with clinical stage IIIA-IIIB breast cancer received NAC consisting of 12 once-a-week cycles of paclitaxel followed by 4 once-every-third-week cycles of FEC.
  
  
  RESULTS
  Fifty patients with LABC were enrolled, 47 of whom were administered paclitaxel followed by FEC as NAC. The clinical response rate for all chemotherapies was 85.1%, and the pathological complete response rate was 27.7%. Regarding toxicity, grade 3-4 neutropenia was observed in 10% of patients. No serious toxicities requiring the discontinuation of treatment were encountered. The rate of breast conservation surgery was 31.9%, median survival had not been reached at the time of conclusion of this study, and the 3-year survival rate was 85.1%. Median disease-free survival was 40.2 months, and the 3-year disease-free survival rate was 62.1%.
  
  
  CONCLUSIONS
  Weekly paclitaxel followed by FEC demonstrated efficacy and tolerable toxicity in a neoadjuvant setting for LABC.
authors.affiliation: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. ttaguchi1@me.com
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Taguchi
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Takahiro
authors.initials: T
authors.lastname: Nakayama
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Motomura
authors.forename: Fumine
authors.initials: F
authors.lastname: Tsukamoto
authors.forename: Kenzo
authors.initials: K
authors.lastname: Shimazu
authors.forename: Takashi
authors.initials: T
authors.lastname: Nomura
authors.forename: Takashi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Wakita
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Nakano
authors.forename: Kohri
authors.initials: K
authors.lastname: Yoneda
authors.forename: Hideo
authors.initials: H
authors.lastname: Inaji
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takatsuka
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use / Q000633:toxicity; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003520:Cyclophosphamide / Q000627:therapeutic use / Q000633:toxicity; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000627:therapeutic use / Q000633:toxicity; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use / Q000633:toxicity; D006801:Humans; D007564:Japan; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000627:therapeutic use* / Q000633:toxicity; D017698:Postmenopause; D017697:Premenopause; D016019:Survival Analysis
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil