Journal article
Long-term (8 years) assessment of trastuzumab-related cardiac events in the HERA trial.
-
De Azambuja, Evandro
Institut Jules Bordet, Brussels, Université Libre de Bruxelles, Ixelles, Belgium, Brussels, Belgium
-
Procter, Marion Jennifer
Frontier Science Scotland (FSS), Kingussie, United Kingdom
-
van Veldhuisen, Dirk
Department of Cardiology, University Medical Center Groningen, Groningen, Netherlands
-
Agbor-Tarh, Dominique
Frontier Science Scotland (FSS), Kincraig, United Kingdom
-
Metzger Filho, Otto
Dana-Farber Cancer Institute, Boston, MA
-
Steinseifer, Jutta
F. Hoffmann-La Roche Ltd, Basel, Switzerland
-
Untch, Michael
Department of Gynecology and Obstetrics and Multidisciplinary Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin, Germany
-
Smith, Ian E.
The Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom
-
Gianni, Luca
San Raffaele Scientific Institute, Milan, Italy
-
Baselga, Jose
Memorial Sloan-Kettering Cancer Center, New York, NY
-
Jackisch, Christian
Klinikum Offenbach, Offenbach, Germany
-
Cameron, David A.
University of Edinburgh, Edinburgh, Scotland
-
Bell, Richard
Barwon Health, Geelong, Australia
-
Leyland-Jones, Brian
The Edith Sanford Breast Cancer Research Institute, Sioux Falls, SD
-
Dowsett, Mitchell
The Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom
-
Gelber, Richard D.
Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, IBCSG, Frontier Science and Technology Research Foundation, Boston, MA
-
Piccart-Gebhart, Martine J.
Jules Bordet Institute, Brussels, Belgium
-
Suter, Thomas
Swiss Cardiovascular Center, Inselspital, Bern University Hospital, Bern, Switzerland
Show more…
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2013, vol. 31, no. 15_suppl, p. 525-525
English
525 Background: Trastuzumab-related cardiac dysfunction may occur in patients (pts) treated with adjuvant therapy and it is mostly reversible. We report the long-term outcome of pts with cardiac dysfunction treated with adjuvant trastuzumab (T) in the Herceptin Adjuvant (HERA) trial. Methods: HERA is a three-arm, randomized trial that compared 1 year or 2 years of T with observation (Obs) in women with HER2-positive early breast cancer (EBC). Eligible pts had a left ventricular ejection fraction (LVEF) ≥ 55% at study entry (i.e. after completion of (neo)adjuvant chemotherapy with or without radiotherapy). Cardiac function was closely monitored throughout the trial. This analysis at 8-year median follow-up considers pts randomly assigned to 1 year or 2 years of T therapy or observation. Results: 5102 pts were randomized to HERA. The “as treated” safety population is considered: 2 years T (N=1,673), 1 year T (N=1,682) and Obs (N=1,744). Cardiac events leading to T discontinuation in the 1-year and 2-year arms were observed in 5.2% and 9.4% of pts, respectively. Cardiac death, severe congestive heart failure (CHF) and confirmed significant LVEF drop remained low in all three arms (Table). In the 1 year T arm, 71.4% of pts with severe CHF, and 81.2% of pts with confirmed LVEF drop recovered cardiac function (at least 2 sequential LVEF assessments > 50%). The median time to recovery was 9.7 months and 6.3 months, respectively. In the 2 years T arm, 87.5% of pts with confirmed LVEF drop recovered cardiac function and median time to recovery was 8.3 months. Conclusions: At 8-year median follow-up the incidence of cardiac events during adjuvant T remains low and these events are mostly reversible. These results confirm low cardiac events when T is given as part of the adjuvant therapy for pts with HER2-positive EBC. Clinical trial information: NCT00045032. [Table: see text]
-
Language
-
-
Open access status
-
closed
-
Identifiers
-
-
Persistent URL
-
https://sonar.ch/global/documents/28989
Statistics
Document views: 15
File downloads: