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Preoperative Twice-Weekly Paclitaxel With Concurrent Radiation Therapy Followed by Surgery and Postoperative Doxorubicin-Based Chemotherapy in Locally Advanced Breast Cancer: A Phase I/II Trial

Silvia C. Formenti, Matthew Volm, Kristin A. Skinner, Darcy Spicer, Deidre Cohen, Edith Perez, Anna C. Bettini, Susan Groshen, Conway Gee, Barbara Florentine, Michael Press, Peter Danenberg, Franco Muggia

From the Kaplan Comprehensive Cancer Center, New York University School of Medicine, New York, NY; Kenneth Norris Jr Comprehensive Cancer Center, University of Southern California Keck School of Medicine, Los Angeles, CA; and Mayo Clinic, Jacksonville, FL.

Address reprint requests to Silvia C. Formenti, MD, Department of Radiation Oncology, New York University School of Medicine, 566 First Ave, New York, NY 10016; email: silvia.formenti{at}med.nyu.edu.

Purpose: Preoperative chemotherapy is the conventional primary treatment in locally advanced breast cancer (LABC). We investigated the safety and efficacy of primary twice-weekly paclitaxel and concurrent radiation (RT) before modified radical mastectomy followed by adjuvant doxorubicin-based chemotherapy.

Patients and Methods: Stage IIB (T3N0) to III LABC patients were eligible. Primary chemoradiation consisted of paclitaxel, 30 mg/m² delivered intravenously for 1 hour twice weekly for a total of 8 to 10 weeks, and concurrent RT (45 Gy at 1.8 Gy/fraction). Modified radical mastectomy was performed at least 2 weeks after completion of chemoradiation or on recovery of skin toxicity. Postoperatively, patients who responded to paclitaxel and RT received four cycles of doxorubicin/paclitaxel, whereas patients who did not respond received doxorubicin/cytoxan.

Results: Forty-four patients were accrued. Toxicity from paclitaxel/RT included grade 3 skin desquamation (7%), hypersensitivity (2%), and stomatitis (2%). Postsurgery complications occurred in six patients (14%). The only grade 4 toxicity of postmastectomy chemotherapy was hematologic (10%). Grade 3 toxicities were leukopenia (24%), infection (22%), peripheral neuropathy (17%), arthralgia and pain (17%), stomatitis (12%), fatigue (10%), esophagitis (5%), and nausea (2%). Overall clinical response rate to preoperative paclitaxel and RT was 91%. Thirty-four percent of patients achieved a pathologic response in the mastectomy specimen: 16% pathologic complete responses (clearance of invasive cancer in the breast and axillary contents) and 18% pathologic partial responses (< 10 residual microscopic foci of invasive breast cancer).

Conclusion: Twice-weekly paclitaxel with concurrent RT is a feasible and effective primary treatment for LABC. Future studies should compare primary chemoradiation to chemotherapy in LABC.

Supported by California Breast Cancer Research Program grant no. 4EB6000, grant no. P30 CA 14089 from the National Cancer Institute, Bethesda, MD, and grant no. M01RR00096 from the National Institutes of Health General Clinical Research Center (NCRR), Bethesda, MD, and by a research grant from Bristol-Meyer Squibb, Princeton, NJ.

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