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

Autor:	Vogel CL; 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., Cobleigh MA; 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., Tripathy D; 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., Gutheil JC; 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., Harris LN; 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., Fehrenbacher L; 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., Slamon DJ; 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., Murphy M; 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., Novotny WF; 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., Burchmore M; 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., Shak S; 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., Stewart SJ; 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., Press M; 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.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Mar 20; Vol. 41 (9), pp. 1638-1645.
DOI:	10.1200/JCO.22.02516
Abstrakt:	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.
Databáze:	MEDLINE
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