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11.10.2019 | Clinical trial

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

Zeitschrift:
Breast Cancer Research and Treatment
Autoren:
Evandro de Azambuja, Noam Ponde, Marion Procter, Priya Rastogi, Reena S. Cecchini, Matteo Lambertini, Karla Ballman, Alvaro Moreno Aspitia, Dimitrios Zardavas, Lise Roca, Richard D. Gelber, Martine Piccart-Gebhart, Thomas Suter
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s10549-019-05453-z) contains supplementary material, which is available to authorized users.
Evandro de Azambuja and Noam Ponde are co-first authors.

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Abstract

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.

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Zusatzmaterial
Supplementary material 1 (DOCX 137 kb)
10549_2019_5453_MOESM1_ESM.docx
Literatur
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