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Originally published as JCO Early Release 10.1200/JCO.2005.10.517 on May 16 2005

Journal of Clinical Oncology, Vol 23, No 16 (June 1), 2005: pp. 3686-3696
© 2005 American Society of Clinical Oncology.
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Paclitaxel After Doxorubicin Plus Cyclophosphamide As Adjuvant Chemotherapy for Node-Positive Breast Cancer: Results From NSABP B-28

Eleftherios P. Mamounas, John Bryant, Barry Lembersky, Louis Fehrenbacher, Scot M. Sedlacek, Bernard Fisher, D. Lawrence Wickerham, Greg Yothers, Atilla Soran, Norman Wolmark

From the National Surgical Adjuvant Breast and Bowel Project, Operations Office and Biostatistical Center; The University of Pittsburgh Medical Center; Allegheny General Hospital, Pittsburgh, PA; Aultman Health Foundation, Canton, OH; Kaiser Permanente, Vallejo, CA; and Rose Medical Center, Denver, CO

Address reprint requests to Eleftherios P. Mamounas, Aultman Health Foundation, 2600 6th St, SW, Canton, OH 44710; e-mail: tmamounas{at}aultman.com

PURPOSE: The primary aim of National Surgical Adjuvant Breast and Bowel Project (NSABP) B-28 was to determine whether four cycles of adjuvant paclitaxel (PTX) after four cycles of adjuvant doxorubicin/cyclophosphamide (AC) will prolong disease-free survival (DFS) and overall survival (OS) compared with four cycles of AC alone in patients with resected operable breast cancer and histologically positive axillary nodes.

PATIENTS AND METHODS: Between August 1995 and May 1998, 3,060 patients were randomly assigned (AC, 1,529; AC followed by PTX [AC -> PTX], 1,531). Patients ≥ 50 years and those younger than 50 years with estrogen receptor (ER) or progesterone receptor (PR) -positive tumors also received tamoxifen for 5 years, starting with the first dose of AC. Postlumpectomy radiotherapy was mandated. Postmastectomy or regional radiotherapy was prohibited. Median follow-up is 64.6 months.

RESULTS: The addition of PTX to AC significantly reduced the hazard for DFS event by 17% (relative risk [RR], 0.83; 95% CI, 0.72 to 0.95; P = .006). Five-year DFS was 76% ± 2% for patients randomly assigned to AC -> PTX compared with 72% ± 2% for those randomly assigned to AC. Improvement in OS was small and not statistically significant (RR, 0.93; 95% CI, 0.78 to 1.12; P = .46). Five-year OS was 85% ± 2% for both groups. Subset analysis of the effect of paclitaxel according to hormone receptors or tamoxifen administration did not reveal statistically significant interaction (for DFS, P = .30 and P = .44, respectively). Toxicity with the AC -> PTX regimen was acceptable for the adjuvant setting.

CONCLUSION: The addition of PTX to AC resulted in significant improvement in DFS but no significant improvement in OS with acceptable toxicity. No significant interaction between treatment effect and receptor status or tamoxifen administration was observed.

Supported by Public Health Service grants U10CA-12027, U10CA-69974, U10CA-37377, and U10CA-69651 from the National Cancer Institute, Department of Health and Human Services, National Institutes of Health (NIH), Bethesda, MD.

Presented in abstract form at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003; interim results were presented at the 2000 NIH Consensus Development Conference, Bethesda, MD, November 1-3, 2000.

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


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