This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Langley, R. E. Articles by Parmar, M. Search for Related Content PubMed PubMed Citation Articles by Langley, R. E. Articles by Parmar, M. Social Bookmarking                            What's this?

Phase III Trial of Epirubicin Plus Paclitaxel Compared With Epirubicin Plus Cyclophosphamide As First-Line Chemotherapy for Metastatic Breast Cancer: United Kingdom National Cancer Research Institute Trial AB01

From the Medical Research Council Clinical Trials Unit; Department of Oncology, University College London; Cancer Research UK (CRUK), Department of Molecular Oncology, Nottingham; CRUK, Department of Oncology, Manchester, United Kingdom; Department of Oncology, Western General Hospital and University of Edinburgh, Edinburgh, Scotland

Address reprint requests to Ruth Langley, MD, Medical Research Council Clinical Trials Unit, 222 Euston Rd, London NW1 2DA, United Kingdom; e-mail: rel{at}ctu.mrc.ac.uk

PURPOSE: To compare the effectiveness and tolerability of epirubicin and paclitaxel (EP) with epirubicin and cyclophosphamide (EC) as first-line chemotherapy for metastatic breast cancer (MBC).

PATIENTS AND METHODS: Patients previously untreated with chemotherapy (except for adjuvant therapy) were randomly assigned to receive either EP (epirubicin 75 mg/m² and paclitaxel 200 mg/m²) or EC (epirubicin 75 mg/m² and cyclophosphamide 600 mg/m²) administered intravenously every 3 weeks for a maximum of six cycles. The primary outcome was progression-free survival; secondary outcome measures were overall survival, response rates, and toxicity.

RESULTS: Between 1996 and 1999, 705 patients (353 EP patients and 352 EC patients) underwent random assignment. Patient characteristics were well matched between the two groups, and 71% of patients received six cycles of treatment. Objective response rates were 65% for the EP group and 55% for the EC group (P = .015). At the time of analysis, 641 patients (91%) had died. Median progression-free survival time was 7.0 months for the EP group and 7.1 months for the EC group (hazard ratio = 1.07; 95% CI, 0.92 to 1.24; P = .41), and median overall survival time was 13 months for the EP group and 14 months for the EC group (hazard ratio = 1.02; 95% CI, 0.87 to 1.19; P = .8). EP patients, compared with EC patients, had more grade 3 and 4 mucositis (6% v 2%, respectively; P = .0006) and grade 3 and 4 neurotoxicity (5% v 1%, respectively; P < .0001).

CONCLUSION: In terms of progression-free survival and overall survival, there was no evidence of a difference between EP and EC. The data demonstrate no additional advantage to using EP instead of EC as first-line chemotherapy for MBC in taxane-naïve patients.

Supported by United Kingdom Medical Research Council, Bristol-Myers Squibb, and Pharmacia Upjohn.

Presented at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.

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

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. WARM, R. KATES, A. THOMAS, T. FISCHER, and N. HARBECK Side-effects of Pre-operative Epirubicin-Paclitaxel Therapy in Primary Breast Cancer Associated with Tumor Biology Anticancer Res, July 1, 2009; 29(7): 2675 - 2680. [Abstract] [Full Text] [PDF]

				D. Mauri, N. P. Polyzos, G. Salanti, N. Pavlidis, and J. P. A. Ioannidis Multiple-Treatments Meta-analysis of Chemotherapy and Targeted Therapies in Advanced Breast Cancer J Natl Cancer Inst, December 17, 2008; 100(24): 1780 - 1791. [Abstract] [Full Text] [PDF]

				S. Verma and M. Clemons First-Line Treatment Options for Patients with HER-2 Negative Metastatic Breast Cancer: The Impact of Modern Adjuvant Chemotherapy Oncologist, July 1, 2007; 12(7): 785 - 797. [Abstract] [Full Text] [PDF]

				M. Colozza, E. de Azambuja, N. Personeni, F. Lebrun, M. J. Piccart, and F. Cardoso Achievements in Systemic Therapies in the Pregenomic Era in Metastatic Breast Cancer Oncologist, March 1, 2007; 12(3): 253 - 270. [Abstract] [Full Text] [PDF]

				H. Roche, P. Fumoleau, M. Spielmann, J.-L. Canon, T. Delozier, D. Serin, M. Symann, P. Kerbrat, P. Soulie, F. Eichler, et al. Sequential Adjuvant Epirubicin-Based and Docetaxel Chemotherapy for Node-Positive Breast Cancer Patients: The FNCLCC PACS 01 Trial J. Clin. Oncol., December 20, 2006; 24(36): 5664 - 5671. [Abstract] [Full Text] [PDF]