PMID- 11821453
OWN - NLM
STAT- MEDLINE
DCOM- 20020328
LR  - 20230315
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 20
IP  - 3
DP  - 2002 Feb 1
TI  - Efficacy and safety of trastuzumab as a single agent in first-line treatment of 
      HER2-overexpressing metastatic breast cancer.
PG  - 719-26
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  - University of Miami School of Medicine, Comprehensive Cancer Research Group Inc, 
      and Columbia Cancer Research Network of Florida, Miami, FL, USA.
FAU - Cobleigh, Melody A
AU  - Cobleigh MA
FAU - Tripathy, Debu
AU  - Tripathy D
FAU - Gutheil, John C
AU  - Gutheil JC
FAU - Harris, Lyndsay N
AU  - Harris LN
FAU - Fehrenbacher, Louis
AU  - Fehrenbacher L
FAU - Slamon, Dennis J
AU  - Slamon DJ
FAU - Murphy, Maureen
AU  - Murphy M
FAU - Novotny, William F
AU  - Novotny WF
FAU - Burchmore, Michael
AU  - Burchmore M
FAU - Shak, Steven
AU  - Shak S
FAU - Stewart, Stanford J
AU  - Stewart SJ
FAU - Press, Michael
AU  - Press M
LA  - eng
GR  - CA48780/CA/NCI NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
CRI - J Clin Oncol. 2023 Mar 20;41(9):1638-1645. PMID: 36921335
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/administration & dosage/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/genetics
MH  - Female
MH  - Gene Amplification
MH  - Genes, erbB-2/*genetics
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization
MH  - Middle Aged
MH  - Quality of Life
MH  - Safety
MH  - Trastuzumab
MH  - Treatment Outcome
EDAT- 2002/02/01 10:00
MHDA- 2002/03/29 10:01
CRDT- 2002/02/01 10:00
PHST- 2002/02/01 10:00 [pubmed]
PHST- 2002/03/29 10:01 [medline]
PHST- 2002/02/01 10:00 [entrez]
AID - 10.1200/JCO.2002.20.3.719 [doi]
PST - ppublish
SO  - J Clin Oncol. 2002 Feb 1;20(3):719-26. doi: 10.1200/JCO.2002.20.3.719.