Phase III randomized trial of doxorubicin and docetaxel versus doxorubicin and cyclophosphamide as primary medical therapy in women with breast cancer: An anglo-celtic cooperative oncology group study

被引:130
作者
Evans, TRJ
Yellowlees, A
Foster, E
Earl, H
Cameron, DA
Hutcheon, AW
Coleman, RE
Perren, T
Gallagher, CJ
Quigley, M
Crown, J
Jones, AL
Highley, M
Robert, LMH
Mansi, JL
机构
[1] Univ Glasgow, Canc Res United Kingdom, Dept Med Oncol, Beatson Labs, Glasgow G61 1BD, Lanark, Scotland
[2] Univ Glasgow, Western Infirm, Beatson Oncol Ctr, Glasgow G11 6NT, Lanark, Scotland
[3] Quant Consulting Ltd, Melrose, Scotland
[4] Western Gen Hosp, Scottish Canc Therapy Network, Dept Oncol, Edinburgh EH4 2XU, Midlothian, Scotland
[5] Addenbrookes Hosp, Dept Oncol, Cambridge, England
[6] Aberdeen Royal Infirm, Aberdeen, Scotland
[7] Weston Pk Hosp, Acad Unit Clin Oncol, Sheffield, S Yorkshire, England
[8] St James Univ Hosp, Leeds LS9 7TF, W Yorkshire, England
[9] St Bartholomews Hosp, Dept Med Oncol, London, England
[10] Gen Hosp St Georg, Dept Med Oncol, London, England
[11] Oldchurch Hosp, Romford RM7 0BE, Essex, England
[12] Ninewells Hosp, Dept Canc Med, Dundee DD1 9SY, Scotland
[13] Singleton Hosp, SW Wales Canc Inst, Swansea SA2 8QA, W Glam, Wales
[14] St Vincents Univ Hosp, Dublin, Ireland
关键词
D O I
10.1200/JCO.2005.06.156
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose To compare the clinical and pathologic response rates of doxorubicin and cyclophosphamide (AC) with doxorubicin and docetaxel (AD) as primary chemotherapy in women with primary or locally advanced breast cancer. Patients and Methods Eligible patients with histologically proven breast cancer with primary tumors : 3 cm, inflammatory or locally advanced disease, and no evidence of metastases were randomly assigned to receive a maximum of six cycles of either doxorubicin (60 mg/m(2)) plus cyclophosphamide (600 mg/m(2)) administered intravenously (IV) every 3 weeks or doxorubicin (60 mg/m(2)) plus docetaxel (75 mg/m(2)) IV every 3 weeks, followed by surgery on completion of chemotherapy. Results A total of 363 patients were randomly assigned to AC (n = 180) or AD (n = 183). A complete clinical response was observed in 17% and 20% of patients treated with AC and AD, respectively (P = .42). Overall (complete and partial) clinical response rates for AC and AD were 61% and 70%, respectively (P = .06). There was no significant difference in either the pathologic complete response rates in the breast with AC (24%) and AD (21%; P = .61) or in the number of patients with positive axillary nodes at surgery with AC (61%) and AD (66%; P = .28). At a median follow-up of 32 months, there is no significant difference between the two groups for the number of relapses. Conclusion In contrast to the positive results reported for sequential docetaxel after AC as primary chemotherapy of breast cancer, our data do not suggest a benefit for simultaneous AD over AC.
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页码:2988 / 2995
页数:8
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