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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.
Lidbrink, E Chmielowska, E Otremba, B Bouhlel, A Lauer, S Liste, H Nuesch, E Shing, M Misra, Vivek
Lidbrink, E
Chmielowska, E
Otremba, B
Bouhlel, A
Lauer, S
Liste, H
Nuesch, E
Shing, M
Misra, Vivek
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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.
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Date
2018
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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.