Key result
In a real-world setting, adjuvant intravenous trastuzumab in patients with HER2-positive early breast cancer was associated with a 2.8% incidence of symptomatic congestive heart failure and a 0.2% incidence of cardiac death.
Why the study?
Cardiac dysfunction risk associated with intravenous trastuzumab treatment may differ in real-world practice compared with randomized trials.
Observational (n=3,733)
Yes
In a large real-world cohort of patients with HER2-positive early breast cancer, adjuvant intravenous trastuzumab was associated with low rates of symptomatic congestive heart failure (2.8%) and cardiac death (0.2%), consistent with clinical trial data.
Answers are grounded in this paper and cite their sources.
Symptomatic CHF incidence reached 2.8% with adjuvant trastuzumab in routine practice; reinforces trial safety data while identifying baseline risk factors for closer monitoring.
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.
No takes yet. Share an insight, caveat, or question.
Lidbrink et al. (2018) conducted an observational in HER2-positive early breast cancer (n=3,733). Intravenous trastuzumab was evaluated on Incidence of symptomatic congestive heart failure (NYHA class II-IV) (95% CI 2.3-3.4). In a real-world setting, adjuvant intravenous trastuzumab in patients with HER2-positive early breast cancer was associated with a 2.8% incidence of symptomatic congestive heart failure and a 0.2% incidence of cardiac death.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: