175P - OHERA – A Real World Study of Cardiac Events in >3700 Patients with HER2-positive Early Breast Cancer Treated with Trastuzumab: Final Analysis

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Complications of Treatment
Breast Cancer
Presenter Elisabeth Lidbrink
Citation Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362
Authors E. Lidbrink1, J. Erfan2, E. Chmielowska3, B. Otremba4, A. Bouhlel5, S. Lauer6, M. Liste Hermoso5, E. Nüesch6, M. Shing7, V. Misra8
  • 1Karolinska Institute, Karolinska University Hospital, SE-171 77 - Stockholm/SE
  • 2Josa Andras, Teaching Hospital, Nyiregyhaza/HU
  • 3Regionalne Centrum Onkologii, Bydgoszcz, Poland and Medical University Nicolaus Copernicus, Torun/PL
  • 4Onkologische Praxis, Oldenburg, Oldenburg/DE
  • 5Global Pharma Development, F Hoffmann-La Roche Ltd, Basel/CH
  • 6Biostatistics, F Hoffmann-La Roche Ltd, Basel/CH
  • 7Genentech Inc, Clovis Oncology Inc, San Francisco/US
  • 8The Christie Clinic, The Christie NHS Foundation Trust, Manchester/GB

Abstract

Background

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.

Methods

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.

Results

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 

Conclusions

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

Funding

F. Hoffmann-La Roche Ltd., Basel, Switzerland

Disclosure

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.