Chan Stefanie Ho Yi, Layton Deborah, Webley Sherael, Salek Sam
School of Life and Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, UK.
Department of Pharmaceutics, UCL School of Pharmacy, London WC1N 1AX, UK.
Cancers (Basel). 2024 Dec 18;16(24):4223. doi: 10.3390/cancers16244223.
Non-small cell lung cancer (NSCLC) is a predominant cause of oncological mortality in the United Kingdom. There is a diverse spectrum of therapeutic options available, such as chemotherapies, targeted therapies and immunotherapies, which have significantly advanced patient prognoses. However, despite these advancements, there is an escalating concern regarding the potential cardiotoxic effects associated with these treatments. This study aimed to explore the association between non-small cell lung cancer treatments and cardiotoxicity. A pharmacovigilance study was conducted utilising the UK Yellow Card System. The proportional reporting ratio (PRR) and reporting odds ratio (ROR) were calculated to detect signals. Among the 56 shortlisted NSCLC drugs, the total number of adverse events reported was 128,214 with 6133 reports being cardiovascular adverse reactions. Among all the drugs analysed, alectinib demonstrated the highest ROR and PRR values, indicating the strongest signal for potential cardiovascular adverse events. This result was comparable to previous studies which also detected a signal of alectinib related to cardiovascular events using the WHO pharmacovigilance database, VigiBase. However, clinical studies demonstrated that alectinib largely improved progression-free survival (PFS) and overall survival in patients. Therefore, it is important to continue monitoring the real-world use of alectinib, so that a benefit-risk balance can be maintained.
非小细胞肺癌（NSCLC）是英国肿瘤死亡的主要原因。目前有多种治疗选择，如化疗、靶向治疗和免疫治疗，这些治疗方法显著改善了患者的预后。然而，尽管有这些进展，但人们对这些治疗潜在的心脏毒性影响的担忧日益增加。本研究旨在探讨非小细胞肺癌治疗与心脏毒性之间的关联。利用英国黄卡系统进行了一项药物警戒研究。计算比例报告率（PRR）和报告比值比（ROR）以检测信号。在入围的56种NSCLC药物中，报告的不良事件总数为128214起，其中6133起为心血管不良反应。在所有分析的药物中，阿来替尼的ROR和PRR值最高，表明潜在心血管不良事件的信号最强。这一结果与之前的研究结果相当，之前的研究也使用世界卫生组织药物警戒数据库VigiBase检测到了与心血管事件相关的阿来替尼信号。然而，临床研究表明，阿来替尼在很大程度上改善了患者的无进展生存期（PFS）和总生存期。因此，继续监测阿来替尼在现实世界中的使用情况非常重要，以便维持获益风险平衡。
