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

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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				S. E. Strome, E. A. Sausville, and D. Mann A Mechanistic Perspective of Monoclonal Antibodies in Cancer Therapy Beyond Target-Related Effects Oncologist, September 1, 2007; 12(9): 1084 - 1095. [Abstract] [Full Text] [PDF]

				C. A. Ritter, M. Perez-Torres, C. Rinehart, M. Guix, T. Dugger, J. A. Engelman, and C. L. Arteaga Human Breast Cancer Cells Selected for Resistance to Trastuzumab In vivo Overexpress Epidermal Growth Factor Receptor and ErbB Ligands and Remain Dependent on the ErbB Receptor Network Clin. Cancer Res., August 15, 2007; 13(16): 4909 - 4919. [Abstract] [Full Text] [PDF]

				D. L. Costantini, C. Chan, Z. Cai, K. A. Vallis, and R. M. Reilly 111In-Labeled Trastuzumab (Herceptin) Modified with Nuclear Localization Sequences (NLS): An Auger Electron-Emitting Radiotherapeutic Agent for HER2/neu-Amplified Breast Cancer J. Nucl. Med., August 1, 2007; 48(8): 1357 - 1368. [Abstract] [Full Text] [PDF]

				C. A. Hudis Trastuzumab -- Mechanism of Action and Use in Clinical Practice N. Engl. J. Med., July 5, 2007; 357(1): 39 - 51. [Full Text] [PDF]

				E. de Alava, A. Ocana, M. Abad, J. C. Montero, A. Esparis-Ogando, C. A. Rodriguez, A. P. Otero, T. Hernandez, J. J. Cruz, and A. Pandiella Neuregulin Expression Modulates Clinical Response to Trastuzumab in Patients With Metastatic Breast Cancer J. Clin. Oncol., July 1, 2007; 25(19): 2656 - 2663. [Abstract] [Full Text] [PDF]

				S. Gori, S. Rimondini, V. De Angelis, M. Colozza, G. Bisagni, G. Moretti, A. Sidoni, C. Basurto, C. Aristei, P. Anastasi, et al. Central Nervous System Metastases in HER-2 Positive Metastatic Breast Cancer Patients Treated with Trastuzumab: Incidence, Survival, and Risk Factors Oncologist, July 1, 2007; 12(7): 766 - 773. [Abstract] [Full Text] [PDF]

				M. H.A. Hussain, G. R. MacVicar, D. P. Petrylak, R. L. Dunn, U. Vaishampayan, P. N. Lara Jr, G. S. Chatta, D. M. Nanus, L. M. Glode, D. L. Trump, et al. Trastuzumab, Paclitaxel, Carboplatin, and Gemcitabine in Advanced Human Epidermal Growth Factor Receptor-2/neu-Positive Urothelial Carcinoma: Results of a Multicenter Phase II National Cancer Institute Trial J. Clin. Oncol., June 1, 2007; 25(16): 2218 - 2224. [Abstract] [Full Text] [PDF]

				N. Dendukuri, K. Khetani, M. McIsaac, and J. Brophy Testing for HER2-positive breast cancer: a systematic review and cost-effectiveness analysis Can. Med. Assoc. J., May 8, 2007; 176(10): 1429 - 1434. [Abstract] [Full Text] [PDF]

				H. Kim, T. Yoo, D. Park, J. Park, Y. Cho, C. Sohn, W. Jeon, B. Kim, M. Kim, S. Chae, et al. Gene amplification and protein overexpression of HER-2/neu in human extrahepatic cholangiocarcinoma as detected by chromogenic in situ hybridization and immunohistochemistry: its prognostic implication in node-positive patients Ann. Onc., May 1, 2007; 18(5): 892 - 897. [Abstract] [Full Text] [PDF]

				M. Scaltriti, F. Rojo, A. Ocana, J. Anido, M. Guzman, J. Cortes, S. Di Cosimo, X. Matias-Guiu, S. Ramon y Cajal, J. Arribas, et al. Expression of p95HER2, a Truncated Form of the HER2 Receptor, and Response to Anti-HER2 Therapies in Breast Cancer J Natl Cancer Inst, April 18, 2007; 99(8): 628 - 638. [Abstract] [Full Text] [PDF]

				R. L. Schilsky Target practice: oncology drug development in the era of genomic medicine Clinical Trials, April 1, 2007; 4(2): 163 - 166. [PDF]

				E. T. Olejniczak, C. Van Sant, M. G. Anderson, G. Wang, S. K. Tahir, G. Sauter, R. Lesniewski, and D. Semizarov Integrative Genomic Analysis of Small-Cell Lung Carcinoma Reveals Correlates of Sensitivity to Bcl-2 Antagonists and Uncovers Novel Chromosomal Gains Mol. Cancer Res., April 1, 2007; 5(4): 331 - 339. [Abstract] [Full Text] [PDF]

				S. A. Limentani, A. M. Brufsky, J. K. Erban, M. Jahanzeb, and D. Lewis 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 J. Clin. Oncol., April 1, 2007; 25(10): 1232 - 1238. [Abstract] [Full Text] [PDF]

				E. Suzuki, R. Niwa, S. Saji, M. Muta, M. Hirose, S. Iida, Y. Shiotsu, M. Satoh, K. Shitara, M. Kondo, et al. A Nonfucosylated Anti-HER2 Antibody Augments Antibody-Dependent Cellular Cytotoxicity in Breast Cancer Patients Clin. Cancer Res., March 15, 2007; 13(6): 1875 - 1882. [Abstract] [Full Text] [PDF]