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"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,"
by Melody A. Cobleigh and 11 others, Journal of Clinical Oncology,
17(9):2639-48, September 1999.
[Authors' affiliations: Rush-Presbyterian-St.
Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of
Florida, Aventura; University of California, San Francisco; Kaiser Permanente,
Vallejo, CA; Genentech Inc., South San Francisco, CA; UCLA School of Medicine,
CA; Fairfax Prince William Hospital, Annandale, VA; Institut Curie, Paris,
France]
Abstract: "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 and 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 s-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. Conclusions:
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."
This 1999 report from the Journal of
Clinical Oncology was cited 28 times in current journal
articles indexed in the ISI database during September-October 2001. During
that two-month period, this was the most-cited paper published in the field of
medicine in the last two years, aside from reviews. Prior to the most recent
bimonthly count, citations to the paper have accrued as follows:
July-August 2001: 18 citations
May-June 2001: 15
March-April 2001: 17
January-February 2001: 5
November-December 2000: 14
September-October 2000: 6
July-August 2000: 6
May-June 2000: 3
March-April 2000: 2
January-February 2000: 1
Total citations to date: 115
SOURCE: Hot
Papers Database (Available from the ISI
Research Services Group in a CD-ROM version containing data on
hundreds of highly cited papers published during the last two years.
User interface permits searching by author, organization, journal,
field, and more. Total citations, as well as citations accrued during
successive bimonthly periods, can be assessed and graphed. Database is
combined with subscription to the ISI newsletter Science
Watch®; updated discs containing the
most recent bimonthly data are mailed with each new issue, six times a
year.)
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