As of Sept 2016, > 2.2 million breast cancer (BC) patients (pts) have received trastuzumab (Herceptin®; H) in clinical trial or real world settings. Risk of cardiac failure in pts treated with H in real world practice may differ from that observed in a clinical trial setting.
OHERA (NCT01152606) is a non-interventional post-approval safety study that investigated incidence of symptomatic congestive heart failure (CHF) and cardiac death in pts with HER2-positive early BC (EBC) receiving adjuvant intravenous H (H IV) in routine clinical practice, per the EU Summary of Product Characteristics (SmPC). Pts with HER2-positive EBC (stage I–IIIb) considered for treatment with H IV per the EU SmPC were enrolled, treated and monitored per local practice. Primary endpoints were incidence of symptomatic CHF (New York Heart Association [NYHA] class II–IV) and incidence of cardiac death. Secondary endpoints included time to onset of CHF. The final analysis included pt data collected for up to 5 years or until death, loss to follow-up or consent withdrawal.
Pts were enrolled Aug 2007–Nov 2010 at 199 sites across 9 countries. The safety population included 3733 pts with EBC treated with H IV. Median treatment duration was 11.8 months; median follow-up was 60.1 months. Incidence of symptomatic CHF was 2.8% (n = 106); including severe symptomatic CHF (NYHA class III–IV) in 1.0% (n = 38) pts. Median time to onset of symptomatic CHF was 5.7 months (95% CI 5.3–6.5) and 77 (72.6%) pts achieved CHF resolution. Incidence of cardiac death was 0.2% (n = 6). 251 pts had a left ventricular ejection fraction (LVEF) drop of ≥ 10% from baseline to
OHERA is the largest study investigating the cardiac safety of adjuvant H IV in a real world setting to date. Final analysis results were consistent with cardiac safety results from previous adjuvant H IV clinical trials in EBC, and the baseline risk factors for CHF reported in the H IV EU SmPC.
Clinical trial identification
Protocol number: BO20652/RO 45-2317 ClinicalTrials.gov NCT01152606
Legal entity responsible for the study
F Hoffmann-La Roche Ltd
F. Hoffmann-La Roche Ltd., Basel, Switzerland
A. Bouhlel, M. Liste Hermoso: Employee of F Hoffmann-La Roche Ltd. S. Lauer: Contract work for Hoffmann-La Roche Ltd. E. Nüesch: Stock ownership: Roche. Employee of F. Hoffmann-La Roche Ltd. M. Shing: Previous employee of Genentech Inc. & current collaboration with Genentech Inc. V. Misra: Membership of an advisory board: Amgen, Eisai, Roche. All other authors have declared no conflicts of interest.