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Originally published as JCO Early Release 10.1200/JCO.2003.12.005 on October 14 2003

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Journal of Clinical Oncology, Vol 21, Issue 22 (November), 2003: 4165-4174
© 2003 American Society for Clinical Oncology

The Effect on Tumor Response of Adding Sequential Preoperative Docetaxel to Preoperative Doxorubicin and Cyclophosphamide: Preliminary Results From National Surgical Adjuvant Breast and Bowel Project Protocol B-27

Harry D. Bear, Stewart Anderson, Ann Brown, Roy Smith, Eleftherios P. Mamounas, Bernard Fisher, Richard Margolese, Heather Theoret, Atilla Soran, D. Lawrence Wickerham, Norman Wolmark

From the Virginia Commonwealth University, Medical College of Virginia School of Medicine, Richmond, VA; National Surgical Adjuvant Breast and Bowel Project; University of Pittsburgh, Graduate School of Public Health; University of Pittsburgh Medical Center, Pittsburgh; Medical College of Pennsylvania/Hahnemann University, Philadelphia, PA; Aultman Hospital Cancer Center, Canton, OH; Jewish General Hospital, Montreal, Quebec.

Address reprint requests to Harry D. Bear, MD, PhD, Box 980011, Division of Surgical Oncology, VCUHS, Richmond, VA 23298-0011; e-mail: hbear{at}hsc.vcu.edu.

Purpose: The National Surgical Adjuvant Breast and Bowel Project Protocol B-27 was designed to determine the effect of adding docetaxel after four cycles of preoperative doxorubicin and cyclophosphamide (AC) on clinical and pathological response rates and on disease-free and overall survival of women with operable breast cancer.

Patients and Methods: Women (N = 2,411) with operable primary breast cancer were randomly assigned to receive either four cycles of preoperative AC followed by surgery (group I), or four cycles of AC followed by four cycles of docetaxel, followed by surgery (group II), or four cycles of AC followed by surgery and then four cycles of docetaxel (group III). Clinical and pathologic tumor responses to preoperative therapy were assessed.

Results: Mean tumor size (4.5 cm) and other key characteristics were evenly balanced among the three treatment arms. Grade 4 toxicity was observed in 10.3% of 2,400 patients during AC treatment, and in 23.4% of 1584 patients during docetaxel treatment. Compared to preoperative AC alone, preoperative AC followed by docetaxel increased the clinical complete response rate (40.1% v 63.6%; P < .001), the overall clinical response rate (85.5% v 90.7%; P < .001), the pathologic complete response rate (13.7% v 26.1%; P < .001), and the proportion of patients with negative nodes (50.8% v 58.2%; P < .001). Pathologic primary breast tumor response was a significant predictor of pathologic nodal status (P < .001).

Conclusion: The addition of four cycles of preoperative docetaxel after four cycles of preoperative AC significantly increased clinical and pathologic response rates for operable breast cancer.

This investigation was supported by Public Health Service Grants U10-CA-37377, U10-CA-69974, U10-CA12027, and U10-CA-69651 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services.

Preliminary results of this study were presented, in part, at the 24th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 10, 2001.

Drs Bear and Mamounas have served on advisory panels for and received honorarium payments for CME activities from Aventis Pharmaceuticals.




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