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

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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 24^th 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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				C. L. Vogel, M. Z. Wojtukiewicz, R. R. Carroll, S. A. Tjulandin, L. J. Barajas-Figueroa, B. L. Wiens, T. A. Neumann, and L. S. Schwartzberg First and Subsequent Cycle Use of Pegfilgrastim Prevents Febrile Neutropenia in Patients With Breast Cancer: A Multicenter, Double-Blind, Placebo-Controlled Phase III Study J. Clin. Oncol., February 20, 2005; 23(6): 1178 - 1184. [Abstract] [Full Text] [PDF]

				N. E. Davidson and M. Morrow Sometimes a Great Notion--An Assessment of Neoadjuvant Systemic Therapy for Breast Cancer J Natl Cancer Inst, February 2, 2005; 97(3): 159 - 161. [Full Text] [PDF]

				D. Mauri, N. Pavlidis, and J. P. A. Ioannidis Neoadjuvant Versus Adjuvant Systemic Treatment in Breast Cancer: A Meta-Analysis J Natl Cancer Inst, February 2, 2005; 97(3): 188 - 194. [Abstract] [Full Text] [PDF]

				K. Iwao-Koizumi, R. Matoba, N. Ueno, S. J. Kim, A. Ando, Y. Miyoshi, E. Maeda, S. Noguchi, and K. Kato Prediction of Docetaxel Response in Human Breast Cancer by Gene Expression Profiling J. Clin. Oncol., January 20, 2005; 23(3): 422 - 431. [Abstract] [Full Text] [PDF]

				M. Cristofanilli, A. Gonzalez-Angulo, N. Sneige, S.-W. Kau, K. Broglio, R. L. Theriault, V. Valero, A. U. Buzdar, H. Kuerer, T. A. Buccholz, et al. Invasive Lobular Carcinoma Classic Type: Response to Primary Chemotherapy and Survival Outcomes J. Clin. Oncol., January 1, 2005; 23(1): 41 - 48. [Abstract] [Full Text] [PDF]

				G. von Minckwitz, J.-U. Blohmer, G. Raab, A. Lohr, B. Gerber, G. Heinrich, H. Eidtmann, M. Kaufmann, J. Hilfrich, C. Jackisch, et al. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer: the GEPARTRIO pilot study Ann. Onc., January 1, 2005; 16(1): 56 - 63. [Abstract] [Full Text] [PDF]

				V. Dieras, P. Fumoleau, G. Romieu, M. Tubiana-Hulin, M. Namer, L. Mauriac, J.-P. Guastalla, E. Pujade-Lauraine, P. Kerbrat, P. Maillart, et al. Randomized Parallel Study of Doxorubicin Plus Paclitaxel and Doxorubicin Plus Cyclophosphamide As Neoadjuvant Treatment of Patients With Breast Cancer J. Clin. Oncol., December 15, 2004; 22(24): 4958 - 4965. [Abstract] [Full Text] [PDF]

				K. S. Albain Adjuvant Chemotherapy for Lymph Node-Negative, Estrogen Receptor-Negative Breast Cancer: A Tale of Three Trials J Natl Cancer Inst, December 15, 2004; 96(24): 1801 - 1804. [Full Text] [PDF]

				P. F. Lebowitz, J. Eng-Wong, S. M. Swain, A. Berman, M. J. Merino, C. K. Chow, D. Venzon, F. Zia, D. Danforth, E. Liu, et al. A Phase II Trial of Neoadjuvant Docetaxel and Capecitabine for Locally Advanced Breast Cancer Clin. Cancer Res., October 15, 2004; 10(20): 6764 - 6769. [Abstract] [Full Text] [PDF]

				E. P. Mamounas Tailoring Loco-Regional Therapy with Neoadjuvant Chemotherapy: Another Step in the Right Direction Ann. Surg. Oncol., October 1, 2004; 11(10): 888 - 891. [Full Text] [PDF]

				M. Colleoni, G. Viale, D. Zahrieh, G. Pruneri, O. Gentilini, P. Veronesi, R. D. Gelber, G. Curigliano, R. Torrisi, A. Luini, et al. Chemotherapy Is More Effective in Patients with Breast Cancer Not Expressing Steroid Hormone Receptors: A Study of Preoperative Treatment Clin. Cancer Res., October 1, 2004; 10(19): 6622 - 6628. [Abstract] [Full Text] [PDF]

				S. Verma, M. Clemons, B. Fitzgerald, and O. Freedman Treatment of locally advanced breast cancer Can. Med. Assoc. J., August 3, 2004; 171(3): 219 - 219. [Full Text] [PDF]

				T. Shenkier, M. Levine, and I. Olivotto Treatment of locally advanced breast cancer Can. Med. Assoc. J., August 3, 2004; 171(3): 221 - 222. [Full Text] [PDF]

				M. S. Mano and A. Awada Primary chemotherapy for breast cancer: the evidence and the future Ann. Onc., August 1, 2004; 15(8): 1161 - 1171. [Abstract] [Full Text] [PDF]

				E. Thomas, F. A. Holmes, T. L. Smith, A. U. Buzdar, D. K. Frye, G. Fraschini, S. E. Singletary, R. L. Theriault, M. D. McNeese, F. Ames, et al. The Use of Alternate, Non-Cross-Resistant Adjuvant Chemotherapy on the Basis of Pathologic Response to a Neoadjuvant Doxorubicin-Based Regimen in Women With Operable Breast Cancer: Long-Term Results From a Prospective Randomized Trial J. Clin. Oncol., June 15, 2004; 22(12): 2294 - 2302. [Abstract] [Full Text] [PDF]

				J. Crown, M. O'Leary, and W.-S. Ooi Docetaxel and Paclitaxel in the Treatment of Breast Cancer: A Review of Clinical Experience Oncologist, June 2, 2004; 9(suppl_2): 24 - 32. [Abstract] [Full Text] [PDF]

				L. G. Estevez and W. J. Gradishar Evidence-Based Use of Neoadjuvant Taxane in Operable and Inoperable Breast Cancer Clin. Cancer Res., May 15, 2004; 10(10): 3249 - 3261. [Abstract] [Full Text] [PDF]

				N. Shahab and S. Haider Is Docetaxel Now an Essential Component of Neoadjuvant Breast Chemotherapy? J. Clin. Oncol., May 1, 2004; 22(9): 1766 - 1766. [Full Text] [PDF]

				H. D. Bear In Reply: J. Clin. Oncol., May 1, 2004; 22(9): 1766 - 1767. [Full Text] [PDF]

				G. W. Sledge Jr Preoperative Chemotherapy for Breast Cancer: Lessons Learned and Future Prospects J. Clin. Oncol., December 15, 2003; 21(24): 4481 - 4482. [Full Text] [PDF]