國家衛生研究院 NHRI:Item 3990099045/4937
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    题名: Longer-term assessment of trastuzumab-related cardiac adverse events in the herceptin adjuvant (HERA) trial
    作者: Procter, M;Suter, TM;de Azambuja, E;Dafni, U;van Dooren, V;Muehlbauer, S;Climent, MA;Rechberger, E;Liu, TW;Toi, M;Coombes, RC;Dodwell, D;Pagani, O;Madrid, J;Hall, M;Chen, SC;Focan, C;Muschol, M;van Veldhuisen, DJ;Piccart-Gebhart, MJ
    贡献者: National Institute of Cancer Research
    摘要: PURPOSE We investigated the incidence of cardiac adverse events in patients with early breast cancer in the Herceptin Adjuvant (HERA) trial who were treated with 1 year of trastuzumab after completion of (neo)adjuvant chemotherapy. PATIENTS AND METHODS The HERA trial is a three-group, randomized trial that compared 1 year or 2 years of trastuzumab with observation in women with human epidermal growth factor receptor-2 (HER2) -positive early breast cancer. Eligible patients had normal left ventricular ejection fraction (LVEF; >/= 55%) after completion of (neo)adjuvant chemotherapy with or without radiotherapy. Cardiac function was monitored throughout the trial. This analysis considers patients randomly assigned to 1 year of trastuzumab treatment or observation. Results There were 1,698 patients randomly assigned to observation and 1,703 randomly assigned to 1 year of trastuzumab treatment; 94.1% of patients had been treated with anthracyclines. The incidence of discontinuation of trastuzumab because of cardiac disorders was low (5.1%). At a median follow-up of 3.6 years, the incidence of cardiac end points remained low, though it was higher in the trastuzumab group than in the observation group (severe CHF, 0.8% v 0.0%; confirmed significant LVEF decreases, 3.6% v 0.6%) In the trastuzumab group, 59 of 73 patients with a cardiac end point reached acute recovery; of these 59 patients, 52 were considered by the cardiac advisory board (CAB) to have a favorable outcome from the cardiac end point. CONCLUSION The incidence of cardiac end points remains low even after longer-term follow-up. The cumulative incidence of any type of cardiac end point increases during the scheduled treatment period of 1 year, but it remains relatively constant thereafter.
    日期: 2010-07
    關聯: Journal of Clinical Oncology. 2010 Jul;28(21):3422-3428.
    Link to: http://dx.doi.org/10.1200/jco.2009.26.0463
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000280003700005
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=77955284228
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