PMID- 36921335
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20230320
LR  - 20240215
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 41
IP  - 9
DP  - 2023 Mar 20
TI  - Efficacy and Safety of Trastuzumab as a Single Agent in First-Line Treatment of 
      HER2-Overexpressing Metastatic Breast Cancer.
PG  - 1638-1645
LID - 10.1200/JCO.22.02516 [doi]
AB  - 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.
FAU - Vogel, Charles L
AU  - Vogel CL
AD  - 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.
FAU - Cobleigh, Melody A
AU  - Cobleigh MA
AD  - 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.
FAU - Tripathy, Debu
AU  - Tripathy D
AD  - 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.
FAU - Gutheil, John C
AU  - Gutheil JC
AD  - 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.
FAU - Harris, Lyndsay N
AU  - Harris LN
AD  - 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.
FAU - Fehrenbacher, Louis
AU  - Fehrenbacher L
AD  - 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.
FAU - Slamon, Dennis J
AU  - Slamon DJ
AD  - 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.
FAU - Murphy, Maureen
AU  - Murphy M
AD  - 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.
FAU - Novotny, William F
AU  - Novotny WF
AD  - 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.
FAU - Burchmore, Michael
AU  - Burchmore M
AD  - 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.
FAU - Shak, Steven
AU  - Shak S
AD  - 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.
FAU - Stewart, Stanford J
AU  - Stewart SJ
AD  - 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.
FAU - Press, Michael
AU  - Press M
AD  - 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.
LA  - eng
GR  - R01 CA048780/CA/NCI NIH HHS/United States
PT  - Corrected and Republished Article
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
SB  - IM
CRF - J Clin Oncol. 2002 Feb 1;20(3):719-26. PMID: 11821453
EDAT- 2023/03/16 06:00
MHDA- 2023/03/16 06:01
CRDT- 2023/03/15 18:12
PHST- 2023/03/15 18:12 [entrez]
PHST- 2023/03/16 06:00 [pubmed]
PHST- 2023/03/16 06:01 [medline]
AID - 10.1200/JCO.22.02516 [doi]
PST - ppublish
SO  - J Clin Oncol. 2023 Mar 20;41(9):1638-1645. doi: 10.1200/JCO.22.02516.