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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

From the Cancer Research-United Kingdom Department of Medical Oncology, University of Glasgow, Beatson Oncology Centre, Western Infirmary, Glasgow; Quantics Consulting Ltd, Melrose; Scottish Cancer Therapy Network, Trinity Park House; Department of Oncology, Western General Hospital, Edinburgh; Department of Oncology, Addenbrooke's Hospital, Cambridge; Aberdeen Royal Infirmary, Aberdeen; Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield; St James' University Hospital, Leeds; Department of Medical Oncology, St Bartholomew's Hospital; Department of Medical Oncology, Royal Free Hospital; Department of Medical Oncology, St George's Hospital, London; Oldchurch Hospital, Romford; Department of Cancer Medicine, Ninewells Hospital, Dundee; South-West Wales Cancer Institute, Singleton Hospital, Swansea; and St Vincent's University Hospital, Dublin, Ireland

Address reprint requests to T.R.J. Evans, MD, Cancer Research United Kingdom Department of Medical Oncology, University of Glasgow, Beatson Laboratories, Garscube Estate, Switchback Rd, Glasgow G61 1BD, United Kingdom; e-mail: j.evans{at}beatson.gla.ac.uk

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/m²) plus cyclophosphamide (600 mg/m²) administered intravenously (IV) every 3 weeks or doxorubicin (60 mg/m²) plus docetaxel (75 mg/m²) 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.

Supported by Aventis Pharma, West Malling, United Kingdom, and Chugai Pharma, London, United Kingdom.

Preliminary results presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002. Completed analysis presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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