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Journal of Clinical Oncology, Vol 20, Issue 3 (February), 2002: 719-726
© 2002 American Society for Clinical Oncology

Efficacy and Safety of Trastuzumab as a Single Agent in First-Line Treatment of HER2-Overexpressing Metastatic Breast Cancer

By Charles L. Vogel, Melody A. Cobleigh, Debu Tripathy, John C. Gutheil, Lyndsay N. Harris, Louis Fehrenbacher, Dennis J. Slamon, Maureen Murphy, William F. Novotny, Michael Burchmore, Steven Shak, Stanford J. Stewart, Michael Press

From University of Miami School of Medicine, Comprehensive Cancer Research Group Inc, and Columbia Cancer Research Network of Florida, Miami, FL; Rush-Presbyterian-St Luke’s Medical Center, Chicago, IL; University of California, San Francisco/Mount Zion Cancer Center, San Francisco; Sidney Kimmel Cancer Center, San Diego; Kaiser Permanente, Vallejo; University of California Los Angeles School of Medicine and University of Southern California School of Medicine, Los Angeles; Genentech, Inc, South San Francisco, CA; and Duke University Medical Center, Durham, NC.

Address reprint requests to Charles L. Vogel, MD, 600 South Pine Island Rd, Suite 104, Plantation, FL 33324.

PURPOSE: To evaluate the efficacy and safety of first-line, single-agent trastuzumab in women with HER2-overexpressing metastatic breast cancer.

PATIENTS AND METHODS: One hundred fourteen women with HER2-overexpressing metastatic breast cancer were randomized to receive first-line treatment with trastuzumab 4 mg/kg loading dose, followed by 2 mg/kg weekly, or a higher 8 mg/kg loading dose, followed by 4 mg/kg weekly.

RESULTS: The objective response rate was 26% (95% confidence interval [CI], 18.2% to 34.4%), with seven complete and 23 partial responses. Response rates in 111 assessable patients with 3+ and 2+ HER2 overexpression by immunohistochemistry (IHC) were 35% (95% CI, 24.4% to 44.7%) and none (95% CI, 0% to 15.5%), respectively. The clinical benefit rates in assessable patients with 3+ and 2+ HER2 overexpression were 48% and 7%, respectively. The response rates in 108 assessable patients with and without HER2 gene amplification by fluorescence in situ hybridization (FISH) analysis were 34% (95% CI, 23.9% to 45.7%) and 7% (95% CI, 0.8% to 22.8%), respectively. Seventeen (57%) of 30 patients with an objective response and 22 (51%) of 43 patients with clinical benefit had not experienced disease progression at follow-up at 12 months or later. The most common treatment-related adverse events were chills (25% of patients), asthenia (23%), fever (22%), pain (18%), and nausea (14%). Cardiac dysfunction occurred in two patients (2%); both had histories of cardiac disease and did not require additional intervention after discontinuation of trastuzumab. There was no clear evidence of a dose-response relationship for response, survival, or adverse events.

CONCLUSION: Single-agent trastuzumab is active and well tolerated as first-line treatment of women with metastatic breast cancer with HER2 3+ overexpression by IHC or gene amplification by FISH.




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