Cited by 1,860HER2/EGFR in Cancer ResearchGastric Cancer Management and OutcomesLung Cancer Treatments and Mutations

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

Vogel, Charles L., Cobleigh, Melody A., Tripathy, Debu, Gutheil, John C., Harris, Lyndsay N., Fehrenbacher, Louis, Slamon, Dennis J., Murphy, Maureen +5 more·2002·Journal of Clinical Oncology

Abstract

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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Crossref · 10.1200/jco.2002.20.3.719

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Authors
Vogel, C. L., Cobleigh, M. A., Tripathy, D., Gutheil, J. C., Harris, L. N., Fehrenbacher, L., Slamon, D. J., Murphy, M., Novotny, W. F., Burchmore, M., Shak, S., Stewart, S. J., & Press, M.
Affiliations
University of Southern California (US)
Venue
Journal of Clinical Oncology
Published
2002-02-01
Volume
20
Issue
3
Pages
719-726
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W4239989216
Cited by
1,860
References
9
Citations by year
2026: 12 · 2025: 34 · 2024: 52 · 2023: 75 · 2022: 113 · 2021: 67 · 2020: 72 · 2019: 62 · 2018: 97 · 2017: 95 · 2016: 87 · 2015: 88 · 2014: 71 · 2013: 91 · 2012: 74
FWCI
32.63
Type
journal article
Language
en
Open access
closed
Locations
Journal of Clinical Oncology (publishedVersion)
Funders
National Cancer Institute (CA48780)
Topics
  • Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gastric Cancer Management and Outcomes
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Keywords
trastuzumab, HER2-positive breast cancer, metastatic breast cancer, first-line therapy, single-agent chemotherapy, HER2 immunohistochemistry, HER2 amplification, objective response rate, adverse cardiac events, dose-response relationship, treatment safety

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