{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T12:28:28Z","timestamp":1775910508631,"version":"3.50.1"},"update-to":[{"DOI":"10.1200\/jco.1999.17.9.2639","type":"new_edition","label":"New edition","source":"publisher","updated":{"date-parts":[[2023,2,28]],"date-time":"2023-02-28T00:00:00Z","timestamp":1677542400000}}],"reference-count":0,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"8","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2023,3,10]]},"abstract":"PURPOSE<\/jats:title> 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. <\/jats:p><\/jats:sec>PATIENTS AND METHODS<\/jats:title> 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. <\/jats:p><\/jats:sec>RESULTS<\/jats:title> 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. <\/jats:p><\/jats:sec>CONCLUSION<\/jats:title> 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. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.22.02510","type":"journal-article","created":{"date-parts":[[2023,3,7]],"date-time":"2023-03-07T23:01:12Z","timestamp":1678230072000},"page":"1501-1510","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":5,"title":["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"],"prefix":"10.1200","volume":"41","author":[{"given":"Melody A.","family":"Cobleigh","sequence":"first","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles L.","family":"Vogel","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debu","family":"Tripathy","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas J.","family":"Robert","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susy","family":"Scholl","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louis","family":"Fehrenbacher","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janet M.","family":"Wolter","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia","family":"Paton","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Shak","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gracie","family":"Lieberman","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dennis J.","family":"Slamon","sequence":"additional","affiliation":[{"name":"From the Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Columbia (HCA) Cancer Research Network of Florida, Aventura, FL; University of California, San Francisco Cancer Center, San Francisco, Kaiser Permanente, Northern California, Vallejo, Genentech, Inc, South San Francisco, and UCLA School of Medicine, Los Angeles, CA; Fairfax Prince William Hospital, Annandale, VA; and Institut Curie, Paris, France."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.22.02510","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,7]],"date-time":"2023-03-07T23:01:42Z","timestamp":1678230102000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.22.02510"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,10]]},"references-count":0,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2023,3,10]]}},"alternative-id":["10.1200\/JCO.22.02510"],"URL":"https:\/\/doi.org\/10.1200\/jco.22.02510","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,10]]},"assertion":[{"value":"2023-02-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}