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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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J. C. Montero, R. Rodriguez-Barrueco, A. Ocana, E. Diaz-Rodriguez, A. Esparis-Ogando, and A. Pandiella
Neuregulins and Cancer
Clin. Cancer Res., June 1, 2008; 14(11): 3237 - 3241.
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R A Walker
Immunohistochemical markers as predictive tools for breast cancer
J. Clin. Pathol., June 1, 2008; 61(6): 689 - 696.
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H. Song, K. Shahverdi, D. L. Huso, C. Esaias, J. Fox, A. Liedy, Z. Zhang, R. T. Reilly, C. Apostolidis, A. Morgenstern, et al.
213Bi ({alpha}-Emitter)-Antibody Targeting of Breast Cancer Metastases in the neu-N Transgenic Mouse Model
Cancer Res., May 15, 2008; 68(10): 3873 - 3880.
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L. B. Michaud
Treatment-experienced breast cancer
Am. J. Health Syst. Pharm., May 15, 2008; 65(10_Supplement_3): S4 - S9.
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A. L. Willis, N. L. Tran, J. M. Chatigny, N. Charlton, H. Vu, S. A.N. Brown, M. A. Black, W. S. McDonough, S. P. Fortin, J. R. Niska, et al.
The Fibroblast Growth Factor-Inducible 14 Receptor Is Highly Expressed in HER2-Positive Breast Tumors and Regulates Breast Cancer Cell Invasive Capacity
Mol. Cancer Res., May 1, 2008; 6(5): 725 - 734.
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C. C. Portera, J. M. Walshe, D. R. Rosing, N. Denduluri, A. W. Berman, U. Vatas, M. Velarde, C. K. Chow, S. M. Steinberg, D. Nguyen, et al.
Cardiac Toxicity and Efficacy of Trastuzumab Combined with Pertuzumab in Patients with Trastuzumab-Insensitive Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer
Clin. Cancer Res., May 1, 2008; 14(9): 2710 - 2716.
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K. Bullock and K. Blackwell
Clinical Efficacy of Taxane-Trastuzumab Combination Regimens for HER-2-Positive Metastatic Breast Cancer
Oncologist, May 1, 2008; 13(5): 515 - 525.
[Abstract] [Full Text] [PDF]

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N. U. Lin, L. A. Carey, M. C. Liu, J. Younger, S. E. Come, M. Ewend, G. J. Harris, E. Bullitt, A. D. Van den Abbeele, J. W. Henson, et al.
Phase II Trial of Lapatinib for Brain Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer
J. Clin. Oncol., April 20, 2008; 26(12): 1993 - 1999.
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S. Pant, M. B. Landon, M. Blumenfeld, W. Farrar, and C. L. Shapiro
Treatment of Breast Cancer With Trastuzumab During Pregnancy
J. Clin. Oncol., March 20, 2008; 26(9): 1567 - 1569.
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R. H. El-Maraghi and E. A. Eisenhauer
Review of Phase II Trial Designs Used in Studies of Molecular Targeted Agents: Outcomes and Predictors of Success in Phase III
J. Clin. Oncol., March 10, 2008; 26(8): 1346 - 1354.
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M. Lidgren, B. Jonsson, C. Rehnberg, N. Willking, and J. Bergh
Cost-effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer
Ann. Onc., March 1, 2008; 19(3): 487 - 495.
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C L Hyun, H E Lee, K S Kim, S-W Kim, J H Kim, G Choe, and S Y Park
The effect of chromosome 17 polysomy on HER-2/neu status in breast cancer
J. Clin. Pathol., March 1, 2008; 61(3): 317 - 321.
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T. C. Haddad and D. Yee
Of Mice and (Wo)Men: Is This Any Way to Test a New Drug?
J. Clin. Oncol., February 20, 2008; 26(6): 830 - 832.
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A. Ocana and A. Pandiella
Identifying Breast Cancer Druggable Oncogenic Alterations: Lessons Learned and Future Targeted Options
Clin. Cancer Res., February 15, 2008; 14(4): 961 - 970.
[Abstract] [Full Text] [PDF]

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Y. Wang, D. M. Ikeda, B. Narasimhan, T. A. Longacre, R. J. Bleicher, S. Pal, R. J. Jackman, and S. S. Jeffrey
Estrogen Receptor-Negative Invasive Breast Cancer: Imaging Features of Tumors with and without Human Epidermal Growth Factor Receptor Type 2 Overexpression
Radiology, February 1, 2008; 246(2): 367 - 375.
[Abstract] [Full Text] [PDF]

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K. M. Aird, X. Ding, A. Baras, J. Wei, M. A. Morse, T. Clay, H. K. Lyerly, and G. R. Devi
Trastuzumab signaling in ErbB2-overexpressing inflammatory breast cancer correlates with X-linked inhibitor of apoptosis protein expression
Mol. Cancer Ther., January 1, 2008; 7(1): 38 - 47.
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F. Revillion, V. Lhotellier, L. Hornez, J. Bonneterre, and J.-P. Peyrat
ErbB/HER ligands in human breast cancer, and relationships with their receptors, the bio-pathological features and prognosis
Ann. Onc., January 1, 2008; 19(1): 73 - 80.
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B. R.J. H. Bird and S. M. Swain
Cardiac Toxicity in Breast Cancer Survivors: Review of Potential Cardiac Problems
Clin. Cancer Res., January 1, 2008; 14(1): 14 - 24.
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M Hofmann, O Stoss, T Gaiser, H Kneitz, P Heinmoller, T Gutjahr, M Kaufmann, T Henkel, and J Ruschoff
Central HER2 IHC and FISH analysis in a trastuzumab (Herceptin) phase II monotherapy study: assessment of test sensitivity and impact of chromosome 17 polysomy
J. Clin. Pathol., January 1, 2008; 61(1): 89 - 94.
[Abstract] [Full Text] [PDF]

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S Selvarajan, L-H Sii, A Lee, G Yip, B-H Bay, M-H Tan, B-T Teh, and P-H Tan
Parafibromin expression in breast cancer: a novel marker for prognostication?
J. Clin. Pathol., January 1, 2008; 61(1): 64 - 67.
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A. Munoz, S. Carrera, J. Ferreiro, A. Ruiz de Lobera, J. M. Mane, and G. Lopez-Vivanco
Reversible liver toxicity with adjuvant trastuzumab for localized breast cancer
Ann. Onc., December 1, 2007; 18(12): 2045 - 2046.
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A. Sapino, F. Montemurro, C. Marchio, G. Viale, J. Kulka, M. Donadio, A. Bottini, G. Botti, A. P. dei Tos, A. Bersiga, et al.
Patients with advanced stage breast carcinoma immunoreactive to biotinylated Herceptin(R) are most likely to benefit from trastuzumab-based therapy: an hypothesis-generating study
Ann. Onc., December 1, 2007; 18(12): 1963 - 1968.
[Abstract] [Full Text] [PDF]

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C. Catania, M. Medici, E. Magni, E. Munzone, D. Cardinale, L. Adamoli, G. Sanna, I. Minchella, D. Radice, A. Goldhirsch, et al.
Optimizing clinical care of patients with metastatic breast cancer: a new oral vinorelbine plus trastuzumab combination
Ann. Onc., December 1, 2007; 18(12): 1969 - 1975.
[Abstract] [Full Text] [PDF]

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L. Harris, H. Fritsche, R. Mennel, L. Norton, P. Ravdin, S. Taube, M. R. Somerfield, D. F. Hayes, and R. C. Bast Jr
American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer
J. Clin. Oncol., November 20, 2007; 25(33): 5287 - 5312.
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K. S. Garman, J. R. Nevins, and A. Potti
Genomic strategies for personalized cancer therapy
Hum. Mol. Genet., October 15, 2007; 16(R2): R226 - R232.
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J. P. Jani, R. S. Finn, M. Campbell, K. G. Coleman, R. D. Connell, N. Currier, E. O. Emerson, E. Floyd, S. Harriman, J. C. Kath, et al.
Discovery and Pharmacologic Characterization of CP-724,714, a Selective ErbB2 Tyrosine Kinase Inhibitor
Cancer Res., October 15, 2007; 67(20): 9887 - 9893.
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L. Pusztai, K. Anderson, and K. R. Hess
Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer
Clin. Cancer Res., October 15, 2007; 13(20): 6080 - 6086.
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F. Orlandi, F. M. Venanzi, A. Concetti, H. Yamauchi, S. Tiwari, L. Norton, J. D. Wolchok, A. N. Houghton, and P. D. Gregor
Antibody and CD8+ T Cell Responses against HER2/neu Required for Tumor Eradication after DNA Immunization with a Flt-3 Ligand Fusion Vaccine
Clin. Cancer Res., October 15, 2007; 13(20): 6195 - 6203.
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C.-H. Lu, S. L. Wyszomierski, L.-M. Tseng, M.-H. Sun, K.-H. Lan, C. L. Neal, G. B. Mills, G. N. Hortobagyi, F. J. Esteva, and D. Yu
Preclinical Testing of Clinically Applicable Strategies for Overcoming Trastuzumab Resistance Caused by PTEN Deficiency
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