Cancer treatment reviews · 2025
Risk of QTc prolongation, and major cardiovascular adverse events associated with CDK4/6 inhibitors in hormone receptor-positive HER2-negative breast cancer - A systematic review and meta-analysis.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод в очереди
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Hoo Yee-Yin, Sia Wei-Wei, Jaya-Prakason Sharminii, Koczwara Bogda, Kong Yek-Ching, Salem Joe-Elie, Dechartres Agnès, Bhoo-Pathy Nirmala
Аннотация
BACKGROUND: Cyclin-Dependent Kinase 4/6 inhibitors (CDK4/6i) improve survival in HR+/HER2- breast cancer, but agent-specific cardiotoxicity remains a concern. We evaluated the risk of QTc prolongation, and other cardiovascular adverse events (CVAEs) associated with ribociclib, palbociclib, and abemaciclib.
METHOD: We conducted a systematic review and meta-analysis (up to May 31st, 2025), assessing QTc prolongation and other CVAEs in patients with HR+/HER2- breast cancer receiving CDK4/6i plus endocrine therapy versus endocrine therapy alone. (PROSPERO: CRD42023460559; UICC Technical Fellowship (TF-20-716796).
RESULTS: Twenty-three studies (22 RCTs, 1 cohort) were included. CDK4/6i increased the risk of grade 3/4 QTc prolongation (RR 1.83, 95% CI 1.23-2.74), driven by ribociclib (RR 1.95, 95% CI 1.27-2.98). Palbociclib showed no association, whereas no abemaciclib trials reported QTc data. VTE risk was elevated overall (RR 2.57, 95% CI 1.53-4.32), highest with abemaciclib (RR 5.14, 95% CI 3.09-8.54), while palbociclib was borderline (RR 2.13, 95% CI 0.99-4.57). Subgroup analyses revealed no consistent effect modifiers for ribociclib (QTc) or abemaciclib (VTE). No significant increase was observed for other composite CVAEs (RR 0.99, 95% CI 0.83-1.19) or for individual CVAEs. A hypothesis-generating signal for supraventricular arrhythmias was noted with abemaciclib (RR 3.87, 95% CI 1.19-12.53), based on sparse events. Heterogeneity was low across analyses.
CONCLUSION: Our findings mandate drug-tailored rather than class-wide cardiovascular monitoring in patients receiving CDK4/6i: ribociclib warrants routine ECG surveillance, abemaciclib requires intensified monitoring for VTE, and palbociclib shows no consistent signal but still merits vigilance.
METHOD: We conducted a systematic review and meta-analysis (up to May 31st, 2025), assessing QTc prolongation and other CVAEs in patients with HR+/HER2- breast cancer receiving CDK4/6i plus endocrine therapy versus endocrine therapy alone. (PROSPERO: CRD42023460559; UICC Technical Fellowship (TF-20-716796).
RESULTS: Twenty-three studies (22 RCTs, 1 cohort) were included. CDK4/6i increased the risk of grade 3/4 QTc prolongation (RR 1.83, 95% CI 1.23-2.74), driven by ribociclib (RR 1.95, 95% CI 1.27-2.98). Palbociclib showed no association, whereas no abemaciclib trials reported QTc data. VTE risk was elevated overall (RR 2.57, 95% CI 1.53-4.32), highest with abemaciclib (RR 5.14, 95% CI 3.09-8.54), while palbociclib was borderline (RR 2.13, 95% CI 0.99-4.57). Subgroup analyses revealed no consistent effect modifiers for ribociclib (QTc) or abemaciclib (VTE). No significant increase was observed for other composite CVAEs (RR 0.99, 95% CI 0.83-1.19) or for individual CVAEs. A hypothesis-generating signal for supraventricular arrhythmias was noted with abemaciclib (RR 3.87, 95% CI 1.19-12.53), based on sparse events. Heterogeneity was low across analyses.
CONCLUSION: Our findings mandate drug-tailored rather than class-wide cardiovascular monitoring in patients receiving CDK4/6i: ribociclib warrants routine ECG surveillance, abemaciclib requires intensified monitoring for VTE, and palbociclib shows no consistent signal but still merits vigilance.