A pooled analysis of the cardiac events in the trastuzumab adjuvant trials.

Autor: de Azambuja E; Institut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium. evandro.azambuja@bordet.be., Ponde N; Institut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium.; AC Camargo Cancer Center, Sao Paulo, Brazil., Procter M; Frontier Science (Scotland), Kincraig, UK., Rastogi P; NRG Oncology, and The University of Pittsburgh Medical Center, Pittsburgh, PA, USA., Cecchini RS; NRG Oncology, and the University of Pittsburgh, Pittsburgh, PA, USA., Lambertini M; Institut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium.; IRCCS Ospedale Policlinico San Martino and University of Genova, GENOVA, Italy., Ballman K; NRG Oncology, and the University of Pittsburgh, Pittsburgh, PA, USA., Aspitia AM; Mayo Clinic, Jacksonville, FL, USA., Zardavas D; Breast International Group (BIG), Brussels, Belgium., Roca L; Institut Regional du Cancer Montpellier Val d'Aurelle, Montpellier, France., Gelber RD; Dana-Farber Cancer Institute, Harvard Medical School, Harvard TH Chan School of Public Health, and Frontier Science and Technology Research Foundation, Boston, MA, USA., Piccart-Gebhart M; Institut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium.; Breast International Group (BIG), Brussels, Belgium., Suter T; University Hospital Bern, Bern, Switzerland.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2020 Jan; Vol. 179 (1), pp. 161-171. Date of Electronic Publication: 2019 Oct 11.
DOI: 10.1007/s10549-019-05453-z
Abstrakt: Background: Trastuzumab-associated cardiotoxicity remains an issue for patients with HER2-positive breast cancer. This pooled analysis of 3 adjuvant trials investigated the incidence, timing, impact on treatment completion, and risk factors for trastuzumab-associated cardiotoxicity.
Methods: This is an individual patient data level pooled analysis of HERA, NSBAP B-31, and NCCTG 9831 (Alliance Trials). Definitions of cardiac events were as per each individual study.
Results: A total of 7445 patients enrolled in the 3 trials were included in the analysis, of which 4017 were in the trastuzumab and 3428 in the control (observation) arms, respectively. Median follow-up exceeded 10 years (119.2-137.2 months). Nearly all patients (97.4%) in the trastuzumab arms received anthracycline-based chemotherapy. In total, 452 patients in the trastuzumab arms experienced a cardiac event (11.3%), with most being mildly symptomatic or asymptomatic left ventricular ejection fraction (LVEF) decrease (351 patients, 8.7%). Severe congestive heart failure was more common in the trastuzumab arm (2.3%) than in the control arm (0.8%). Most cardiac events occurred during trastuzumab treatment (78.1%) and cardiac events were the main cause of discontinuation across the sample (10.0%); nevertheless, a large majority of patients completed trastuzumab treatment (76.2%). Baseline risk factors that were significantly associated with the development of cardiac events were baseline LVEF < 60%, hypertension, body mass index > 25, age ≥ 60 and, non-Caucasian ethnicity.
Conclusion: One year of trastuzumab increases the risk of cardiac events, though most consist of asymptomatic or mildly symptomatic LVEF drops. Adjuvant trastuzumab should be considered a safe treatment from a cardiac standpoint for most patients. Trastuzumab-associated cardiotoxicity is the main cause of discontinuation and further research is needed to individualize prevention and management.
Databáze: MEDLINE
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