Tzuberi Maor, Brzezinski Rafael Y, Flint Nir, Slieman Moaad, Zornitzki Lior, Viskin Dana, Hemed Anna Rozenfeld, Waissengrin Barliz, Barak Renana, Golomb Inbal, Wolf Ido, Golan Netanel, Topilsky Yan, Banai Shmuel, Kapusta Livia, Laufer-Perl Michal
Division of Cardiology, Tel Aviv Sourasky medical Center, Tel Aviv, Israel.
School of Medicine, Tel Aviv University, 6 Weizmann Street, Tel Aviv, Israel.
Cardiooncology. 2025 Jan 8;11(1):2. doi: 10.1186/s40959-024-00297-z.
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment outcomes. However, the response varies across different populations, and their use may lead to life-threatening cardiovascular (CV) events. While pre-treatment reduced left ventricular ejection fraction (LVEF) is considered a marker for high-risk cardiotoxicity and a contraindication for anthracycline and HER2-targeted therapies, there is limited evidence on the safety and efficacy of ICIs therapy in patients presenting with pre-treatment reduced LVEF. The study aims to evaluate the safety and efficacy of ICIs therapy in patients with pre-treatment reduced LVEF.
Retrospective single center cohort of patients treated with ICIs therapy, who performed pre-treatment LVEF assessment. The primary endpoint was to evaluate the safety of ICIs among this population, assessed by CV events (composite of myocarditis, acute coronary syndrome, heart failure, and arrhythmias). The secondary endpoint was to evaluate the efficacy of ICIs, assessed by all-cause mortality and progression-free survival (PFS).
The cohort included 307 patients, with 30 (10%) presenting with pre-treatment reduced LVEF, with a mean LVEF of 39 ± 7%. While a significantly higher incidence of CV events was observed in the reduced LVEF group (37% vs. 14%, p = 0.004), following a multivariate Cox regression analysis including baseline CV diseases and risk factors, pre-treatment reduced LVEF did not remain a significant independent predictor (p = 0.358). No significant differences were observed between the groups regarding all-cause mortality and PFS.
Pre-treatment reduced LVEF was not identified as an independent marker for clinical outcomes in patients treated with ICIs therapy.
免疫检查点抑制剂（ICI）彻底改变了癌症治疗的结果。然而，不同人群的反应各不相同，其使用可能会导致危及生命的心血管（CV）事件。虽然治疗前左心室射血分数（LVEF）降低被认为是高风险心脏毒性的标志物以及蒽环类药物和HER2靶向治疗的禁忌症，但关于ICI治疗在治疗前LVEF降低的患者中的安全性和有效性的证据有限。本研究旨在评估ICI治疗在治疗前LVEF降低的患者中的安全性和有效性。
对接受ICI治疗且进行了治疗前LVEF评估的患者进行回顾性单中心队列研究。主要终点是评估该人群中ICI的安全性，通过CV事件（心肌炎、急性冠状动脉综合征、心力衰竭和心律失常的综合）进行评估。次要终点是评估ICI的有效性，通过全因死亡率和无进展生存期（PFS）进行评估。
该队列包括307名患者，其中30名（10%）治疗前LVEF降低，平均LVEF为39±7%。虽然在LVEF降低的组中观察到CV事件的发生率显著更高（37%对14%，p=0.004），但在包括基线CV疾病和危险因素的多变量Cox回归分析后，治疗前LVEF降低不再是一个显著的独立预测因素（p=0.358）。两组在全因死亡率和PFS方面未观察到显著差异。
治疗前LVEF降低未被确定为接受ICI治疗患者临床结局的独立标志物。
