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    A real-world study of cardiac events in > 3700 patients with HER2-positive early breast cancer treated with trastuzumab: final analysis of the OHERA study.

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    Authors
    Lidbrink, E
    Chmielowska, E
    Otremba, B
    Bouhlel, A
    Lauer, S
    Liste, H
    Nuesch, E
    Shing, M
    Misra, Vivek
    Affiliation
    Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden
    Issue Date
    2018
    
    Metadata
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    Abstract
    PURPOSE: Cardiac dysfunction risk associated with intravenous trastuzumab (H IV) treatment may differ in real-world practice versus randomized trials. We investigated cardiac events in patients with HER2-positive early breast cancer (EBC) treated with H IV as adjuvant therapy in routine practice. METHODS: The observational study of cardiac events in patients with HER2-positive EBC treated with Herceptin (OHERA; NCT01152606) enrolled patients with stage I-IIIb disease eligible for H IV in the adjuvant setting per the European Summary of Product Characteristics (SmPC). Primary outcomes were symptomatic congestive heart failure incidence (CHF; New York Heart Association class II-IV) and cardiac death. Patient visits/assessments were per local practice. RESULTS: 3733 Patients received???1 H IV dose per local practice; 88.9% received H IV for >?300 days (median follow-up: ~ 5 years). Prior to disease recurrence (if any), symptomatic CHF occurred in 106 patients (2.8%); 6 (0.2%) cardiac deaths occurred (5 in patients with cardiac disease history). Median time to symptomatic CHF onset was 5.7 months (95% CI 5.3-6.5); 77/106 (72.6%) patients with symptomatic CHF achieved resolution. CHF incidence was higher in patients???65 years, and those with pre-existing cardiac conditions, hypertension, or left ventricular ejection fraction???55% at baseline. CONCLUSIONS: OHERA is the largest prospective observational study to investigate the cardiac safety of H IV as adjuvant EBC therapy in a real-world setting. Symptomatic CHF and cardiac event incidences were consistent with randomized trials in this setting and baseline risk factors identified in the H IV European SmPC.
    Citation
    Lidbrink E, Chmielowska E, Otremba B, Bouhlel A, Lauer S, Liste Hermoso M, et al. A real-world study of cardiac events in > 3700 patients with HER2-positive early breast cancer treated with trastuzumab: final analysis of the OHERA study. Breast Cancer Res Treat. 2018 Nov 30.
    Journal
    Breast Cancer Res Treat
    URI
    http://hdl.handle.net/10541/621460
    DOI
    10.1007/s10549-018-5058-6
    PubMed ID
    30506110
    Additional Links
    https://dx.doi.org/10.1007/s10549-018-5058-6
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1007/s10549-018-5058-6
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