A phase II study of neoadjuvant docetaxel plus doxorubicin (KBCS-01) in stage II, III breast cancer.
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.
Han
Sehwan
S
Division of Breast Oncology, Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Republic of Korea. shwhan@unitel.co.kr
Kim
Sung-Bae
SB
Kang
Sung Soo
SS
Noh
Woo-Chul
WC
Paik
Nam-Sun
NS
Chang
Eil-Sung
ES
Kim
Je-Ryong
JR
Lim
Sook-Hyun
SH
Park
Hee-Sook
HS
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
D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin