title: A phase II study of neoadjuvant docetaxel plus doxorubicin (KBCS-01) in stage II, III breast cancer.
abstract: BACKGROUND
  This multicenter phase II study was conducted to evaluate the response and safety of a combination of docetaxel plus doxorubicin as neoadjuvant therapy for stage II, III breast cancer.
  
  
  METHODS
  Patients with stage II or III breast cancer underwent three cycles of neoadjuvant chemotherapy with doxorubicin 50 mg/m2 and docetaxel 75 mg/m2 every 3 weeks followed by curative surgery. Prophylactic GCSF was not used.
  
  
  RESULTS
  Ninety patients were enrolled in the study and 86 were evaluable for efficacy. The median age was 43 years (range, 30-69). The mean relative dose intensity was 0.98 for docetaxel and 0.98 for doxorubicin. Breast-conserving surgery was performed in 12 (13.7%) patients. The clinical overall response rate was 86% and pathologic complete response was 10.5%. Grade 3/4 neutropenia was observed in 26% of total 258 cycles and febrile neutropenia was observed in 15.8%. Pneumonia was observed in one patient and grade 3 mucositis was observed in three patients.
  
  
  CONCLUSIONS
  Docetaxel and doxorubicin was an effective and well-tolerated neoadjuvant chemotherapy for stage II and III breast cancer. Clinical benefit of this treatment will be confirmed by survival data with long term follow up.
authors.affiliation: Division of Breast Oncology, Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Republic of Korea. shwhan@unitel.co.kr
authors.forename: Sehwan
authors.initials: S
authors.lastname: Han
authors.forename: Sung-Bae
authors.initials: SB
authors.lastname: Kim
authors.forename: Sung Soo
authors.initials: SS
authors.lastname: Kang
authors.forename: Woo-Chul
authors.initials: WC
authors.lastname: Noh
authors.forename: Nam-Sun
authors.initials: NS
authors.lastname: Paik
authors.forename: Eil-Sung
authors.initials: ES
authors.lastname: Chang
authors.forename: Je-Ryong
authors.initials: JR
authors.lastname: Kim
authors.forename: Sook-Hyun
authors.initials: SH
authors.lastname: Lim
authors.forename: Hee-Sook
authors.initials: HS
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D043823:Taxoids / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin