Originally published as JCO Early Release 10.1200/JCO.2008.16.7841 on August 4 2008

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Concurrent Doxorubicin Plus Docetaxel Is Not More Effective Than Concurrent Doxorubicin Plus Cyclophosphamide in Operable Breast Cancer With 0 to 3 Positive Axillary Nodes: North American Breast Cancer Intergroup Trial E 2197

Lori J. Goldstein, Anne O'Neill, Joseph A. Sparano, Edith A. Perez, Lawrence N. Shulman, Silvana Martino, Nancy E. Davidson

From the Fox Chase Cancer Center, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA; Montefiore Medical Center, Bronx, NY; Mayo Clinic, Jacksonville, FL; The Angeles Clinic and Research Institute, Santa Monica, CA; and the Sidney Kimmel Cancer Center at Johns Hopkins University, Baltimore, MD

Corresponding author: Lori J. Goldstein, MD, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111; e-mail: lori.goldstein{at}fccc.edu

Purpose The combination of doxorubicin and cyclophosphamide (AC) is a standard adjuvant regimen. Doxorubicin and docetaxel (AT) is one of the most active cytotoxic regimens for metastatic breast cancer. The purpose of this trial was to determine whether adjuvant AT improved disease-free survival compared with AC in operable breast cancer.

Patients and Methods Women with invasive breast cancer were eligible if there were one to three positive lymph nodes or if the node-negative tumor was greater than 1 cm. Patients were randomly assigned after surgery to receive doxorubicin (60 mg/m²) plus either cyclophosphamide (600 mg/m²; AC) or docetaxel (60 mg/m²; AT) given every 3 weeks for four cycles, followed by hormone therapy for patients with estrogen receptor (ER) and/or progesterone receptor (PR)–positive tumors.

Results There were 2,882 eligible patients enrolled. After a median follow-up of 79.5 months, there was no significant difference in disease-free survival (DFS; 85% in both arms) or overall survival (91% v 92%) at 5 years. The hazard ratio for AC versus AT was 1.02 (95% CI for DFS, 0.86 to 1.22; P = .78). In an exploratory analysis of prespecified stratification factors by ER and PR expression there were trends toward improved DFS for AT in ER/PR-negative disease. Grade 3 neutropenia associated with fever or infection occurred more often with AT (26% v 10%; P < .05).

Conclusion AT did not improve DFS or overall survival in this population, and was associated with more toxicity.

published online ahead of print at www.jco.org on August 4, 2008

Supported in part by Grants No. CA027525 and P30-CA006927 from the Department of Health and Human Services and the National Institutes of Health. This study was coordinated by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service Grants No. CA23318, CA66636, CA21115, CA27525, CA14958, CA25224, CA32291, CA32102, CA16116, and from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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