PMID- 10561337
OWN - NLM
STAT- MEDLINE
DCOM- 20000105
LR  - 20231120
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 17
IP  - 9
DP  - 1999 Sep
TI  - Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal 
      antibody in women who have HER2-overexpressing metastatic breast cancer that has 
      progressed after chemotherapy for metastatic disease.
PG  - 2639-48
AB  - PURPOSE: Overexpression of the HER2 protein occurs in 25% to 30% of human breast 
      cancers and leads to a particularly aggressive form of the disease. Efficacy and 
      safety of recombinant humanized anti-HER2 monoclonal antibody as a single agent 
      was evaluated in women with HER2-overexpressing metastatic breast cancer that had 
      progressed after chemotherapy for metastatic disease. PATIENTS AND METHODS: Two 
      hundred twenty-two women, with HER2-overexpressing metastatic breast cancer that 
      had progressed after one or two chemotherapy regimens, were enrolled. Patients 
      received a loading dose of 4 mg/kg intravenously, followed by a 2-mg/kg 
      maintenance dose at weekly intervals. RESULTS: Study patients had advanced 
      metastatic disease and had received extensive prior therapy. A blinded, 
      independent response evaluation committee identified eight complete and 26 
      partial responses, for an objective response rate of 15% in the intent-to-treat 
      population (95% confidence interval, 11% to 21%). The median duration of response 
      was 9.1 months; the median duration of survival was 13 months. The most common 
      adverse events, which occurred in approximately 40% of patients, were 
      infusion-associated fever and/or chills that usually occurred only during the 
      first infusion, and were of mild to moderate severity. These symptoms were 
      treated successfully with acetaminophen and/or diphenhydramine. The most 
      clinically significant adverse event was cardiac dysfunction, which occurred in 
      4.7% of patients. Only 1% of patients discontinued the study because of 
      treatment-related adverse events. CONCLUSION: Recombinant humanized anti-HER2 
      monoclonal antibody, administered as a single agent, produces durable objective 
      responses and is well tolerated by women with HER2-overexpressing metastatic 
      breast cancer that has progressed after chemotherapy for metastatic disease. Side 
      effects that are commonly observed with chemotherapy, such as alopecia, 
      mucositis, and neutropenia, are rarely seen.
FAU - Cobleigh, M A
AU  - Cobleigh MA
AD  - Rush-Presbyterian-St Luke's Medical Center, Chicago, IL 60612, USA.
FAU - Vogel, C L
AU  - Vogel CL
FAU - Tripathy, D
AU  - Tripathy D
FAU - Robert, N J
AU  - Robert NJ
FAU - Scholl, S
AU  - Scholl S
FAU - Fehrenbacher, L
AU  - Fehrenbacher L
FAU - Wolter, J M
AU  - Wolter JM
FAU - Paton, V
AU  - Paton V
FAU - Shak, S
AU  - Shak S
FAU - Lieberman, G
AU  - Lieberman G
FAU - Slamon, D J
AU  - Slamon DJ
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
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  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
CRI - J Clin Oncol. 2023 Mar 10;41(8):1501-1510. PMID: 36881998
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/adverse effects/pharmacokinetics/*therapeutic use
MH  - Breast Neoplasms/drug therapy/metabolism/*therapy
MH  - Confidence Intervals
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Female
MH  - Heart Diseases/etiology
MH  - Humans
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Quality of Life
MH  - Receptor, ErbB-2/*immunology/metabolism
MH  - Time Factors
EDAT- 1999/11/24 00:00
MHDA- 1999/11/24 00:01
CRDT- 1999/11/24 00:00
PHST- 1999/11/24 00:00 [pubmed]
PHST- 1999/11/24 00:01 [medline]
PHST- 1999/11/24 00:00 [entrez]
AID - 10.1200/JCO.1999.17.9.2639 [doi]
PST - ppublish
SO  - J Clin Oncol. 1999 Sep;17(9):2639-48. doi: 10.1200/JCO.1999.17.9.2639.