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Originally published as JCO Early Release 10.1200/JCO.2005.06.232 on August 8 2005

Journal of Clinical Oncology, Vol 23, No 25 (September 1), 2005: pp. 5983-5992
© 2005 American Society of Clinical Oncology.
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Weekly Paclitaxel Improves Pathologic Complete Remission in Operable Breast Cancer When Compared With Paclitaxel Once Every 3 Weeks

Marjorie C. Green, Aman U. Buzdar, Terry Smith, Nuhad K. Ibrahim, Vicente Valero, Marguerite F. Rosales, Massimo Cristofanilli, Daniel J. Booser, Lajos Pusztai, Edgardo Rivera, Richard L. Theriault, Cynthia Carter, Debra Frye, Kelly K. Hunt, W. Fraser Symmans, Eric A. Strom, Aysegul A. Sahin, William Sikov, Gabriel N. Hortobagyi

From The University of Texas M.D. Anderson Cancer Center, Houston, TX; and Brown University, Providence, RI

Address reprint requests to Marjorie C. Green, MD, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 424, Houston, TX 77030; e-mail: mgreen{at}mdanderson.org

PURPOSE: To determine the impact a change in schedule of paclitaxel administration from once every 3 weeks to frequent administration would have on the pathologic complete response (pCR) rate in the breast and lymph nodes for patients with invasive breast cancer treated with primary systemic chemotherapy (PST).

PATIENTS AND METHODS: Patients with clinical stage I-IIIA breast cancer were randomly assigned to receive PST of paclitaxel doses administered either weekly (for a total of 12 doses of paclitaxel) or once every 3 weeks (four cycles), followed by four cycles of fluorouracil/doxorubicin/cyclophosphamide (FAC) in standard doses every 3 weeks. Two different doses of paclitaxel were used based on lymph node status defined by ultrasound and fine needle aspiration. Clinical response and extent of residual disease in the breast and lymph nodes was assessed after completion of all chemotherapy.

RESULTS: A total of 258 patients were randomly assigned to receive doses of paclitaxel administered either weekly or once every 3 weeks, followed by FAC. Of these 258 patients, 110 patients had histologic lymph node involvement and 148 patients had clinical N0 disease. Weekly paclitaxel followed by FAC was administered to 127 patients and once-every-3-weeks paclitaxel followed by FAC was administered to 131 patients. Clinical response to treatment was similar between groups (P = .25). Patients receiving weekly paclitaxel had a higher pCR rate (28.2%) than patients treated with once-every-3-weeks paclitaxel (15.7%; P = .02), with improved breast conservation rates (P = .05).

CONCLUSION: The change in schedule of paclitaxel from once every 3 weeks to a more frequent administration significantly improved the ability to eradicate invasive cancer in the breast and lymph nodes.

Supported in part by a research grant from Bristol-Meyers Squibb.

Presented at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001; at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002; and in Green MC, Thomas E: Preoperative systemic therapy for operable breast cancer, in Singletary E (ed): Advanced Therapy of Breast Disease. Hamilton, Ontario, Canada, BC Decker, 2004, pp 479-488.

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


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