title: Comparison of 6 cycles versus 4 cycles of neoadjuvant epirubicin plus docetaxel chemotherapy in stages II and III breast cancer.
abstract: BACKGROUND
  This phase III clinical study was designed to investigate whether 6 cycles of epirubicin plus docetaxel (ED) is more effective than 4 cycles of ED as neoadjuvant chemotherapy (NC) in patients with stage II or III breast cancer.
  
  
  METHODS
  Women with breast cancer that had tumors larger than 3 cm were prospectively randomized to receive 4 or 6 cycles of epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2) every 3 weeks. The primary end point was the clinical response to NC.
  
  
  RESULTS
  A total of 176 patients were randomly assigned, and 150 patients were assessable for efficacy and toxicity. Groups were well balanced for clinicopathologic parameters. The median age was 42 years (range 30-58). Overall clinical response was observed in 72% with ED4 and 82% with ED6. pCR was observed in 11% with ED4 and in 24% with ED6 (p=0.047). 47% of the ED4 group underwent breast conserving surgery (BCS) whereas 58% of ED6 group underwent BCS. Grade 3/4 neutropenia was observed in 27% in ED4 and 31% in ED6. Febrile neutropenia occurred in 17% with ED4 and 19% with ED6. Grade 3 mucositis was observed in 8% with ED4 and in 6% with ED6.
  
  
  CONCLUSIONS
  Six cycles of ED enhanced the rates of pCR and BCS compared with 4 cycles without increasing treatment-related toxicities.
authors.affiliation: Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, South Korea.
authors.forename: Sehwan
authors.initials: S
authors.lastname: Han
authors.forename: Jeryong
authors.initials: J
authors.lastname: Kim
authors.forename: Jinsun
authors.initials: J
authors.lastname: Lee
authors.forename: Eilsung
authors.initials: E
authors.lastname: Chang
authors.forename: Geumhee
authors.initials: G
authors.lastname: Gwak
authors.forename: Hyunjin
authors.initials: H
authors.lastname: Cho
authors.forename: Keun Ho
authors.initials: KH
authors.lastname: Yang
authors.forename: Sungjin
authors.initials: S
authors.lastname: Park
authors.forename: Kyeongmee
authors.initials: K
authors.lastname: Park
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin