MANTICORE 101-Breast
Multidisciplinary Approach to Novel Therapies in Cardio-Oncology Research 101-Breast
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 94 patients with HER2-positive early breast cancer starting adjuvant trastuzumab, perindopril or bisoprolol did not prevent trastuzumab-mediated left ventricular remodelling, although both attenuated the fall in ejection fraction, compared with placebo.
N
94
Disegno
Double-blind, placebo-controlled RCT with three parallel arms
Esito
Change in indexed left ventricular end-diastolic volume on cardiac MRI
Rilevanza
3
RisultatoIndexed end-diastolic volume +7 (perindopril), +8 (bisoprolol) and +4 mL/m² (placebo; p=0.36) — primary endpoint neutral. LVEF decline attenuated with bisoprolol −1%, vs perindopril −3% and placebo −5% (p=0.001).
Pituskin E, Mackey JR, Koshman S, et al. J Clin Oncol. 2017;35(8):870-877. 10.1200/JCO.2016.68.7830
Discussione e critica
The primary remodelling endpoint was formally negative, so the positive ejection-fraction finding is secondary and hypothesis-generating. It is still the best randomised evidence for neurohormonal prophylaxis specifically under anti-HER2 therapy.