Originally published as JCO Early Release 10.1200/JCO.2005.05.3306 on February 12 2007

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Phase II Study of Neoadjuvant Docetaxel, Vinorelbine, and Trastuzumab Followed by Surgery and Adjuvant Doxorubicin Plus Cyclophosphamide in Women With Human Epidermal Growth Factor Receptor 2–Overexpressing Locally Advanced Breast Cancer

Steven A. Limentani, Adam M. Brufsky, John K. Erban, Mohammed Jahanzeb, Deborah Lewis

From the Carolinas Hematology-Oncology Associates; The Blumenthal Cancer Center, Charlotte, NC; Department of Medicine, Division of Hematology-Oncology, University of Pittsburgh Magee-Womens Hospital, Pittsburgh, PA; Department of Medicine, Tufts-New England Medical Center, Boston, MA; and the Division of Hematology-Oncology, University of Tennessee College of Medicine, Memphis, TN

Address reprint requests to Steven A. Limentani, MD, University of North Carolina, Blumenthal Cancer Center, Carolinas Hematology-Oncology Associates, 1100 South Tryon St, Charlotte, NC 28203; e-mail: slimentani{at}carolinas.org

Purpose To evaluate the combination of docetaxel, vinorelbine, and trastuzumab as neoadjuvant therapy for human epidermal growth factor receptor 2 (HER2) –overexpressing breast cancer.

Patients and Methods Patients with stage IIB or III breast cancer, including inflammatory disease, and HER2 overexpression (determined by fluorescent in situ hybridization) were treated with six cycles of docetaxel 60 mg/m² and vinorelbine 45 mg/m² administered every 14 days with granulocyte colony-stimulating factor and quinolone prophylaxis. Trastuzumab was administered as a 4 mg/kg loading dose followed by 2 mg/kg weekly for 12 weeks. The primary efficacy end point was pathologic complete response (pCR) in the breast.

Results Of 31 enrolled patients, 68% had T3 or T4 tumors and 90% were clinically node positive. Twelve patients (39%; 95% CI, 21.6% to 55.9%) achieved pCR in the breast and lymph nodes and 14 patients (45%; 95% CI, 27.6% to 62.7%) achieved pCR in the breast alone, and 19 patients (61%; 95% CI, 44.1% to 78.4%) were node negative after neoadjuvant therapy. Clinical response was documented in 29 patients (94%; 95% CI, 78.6% to 99.2%) with 26 complete responses (84%; 95% CI, 70.9% to 96.8%). The most commonly reported grade 3/4 toxicities were neutropenia (97%), febrile neutropenia (22%), anemia (6%), mucositis/stomatitis (6%), constipation (6%), and skin rash (6%).

Conclusion With clinical response and pCR rates of 94% and 39%, respectively, docetaxel, vinorelbine, and trastuzumab is a highly active neoadjuvant therapy for HER2-overexpressing locally advanced breast cancer. Although well tolerated overall, significant febrile neutropenia was observed despite prophylactic measures; therefore, evaluating a similar regimen using lower docetaxel and/or vinorelbine doses is warranted.

published online ahead of print at www.jco.org on February 12, 2007.

Supported by grants from Aventis Pharmaceuticals Inc.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL.

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

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