Capecitabine (CAP) is one of the most commonly prescribed fluoropyrimidines in oncology, especially in the treatment of colon cancer. Cardiac toxicity is a severe and potentially lethal adverse drug reaction (ADR) against fluoropyrimidines. Cardiac ADRs, such as myocardial infarction (MI), heart failure (HF), arrhythmias, and a number of cardiomyopathies, are reported for these molecules. To have a better understanding of the risk–benefit ratio of colon cancer therapy, a pharmacovigilance study of real-world evidence of the cardiac toxicity of antineoplastic agents is required. Aim: This post-marketing research on CAP aims to assess the risk of cardiac toxicity. Five other antitumor drugs used in colorectal cancer, i.e., 5-fluorouracil (5-FU), irinotecan (IRI), oxaliplatin (OX), bevacizumab (BEV) and panitumumab (PAN), were also studied to create a relative profile of observed cardiotoxicity. Methods: A retrospective study based on reports submitted in the EudraVigilance (EV) database until 28 July 2024 was conducted. Using the aggregated data from EV, a descriptive analysis and disproportionality analysis of cardiac ADRs induced by fluoropyrimidines were performed. To evaluate the disproportionality of the signals, Reporting Odds Ratio (ROR) and 95% confidence interval (95% CI) were calculated by comparison with other drugs used in colorectal cancer: 5-FU, IRI, OX, BEV, and PAN. Results: “Cardiac disorders” represent 3.4% of the total reports for CAP. The value is comparable to 5-FU, but higher than for other drugs. t was observed that there are no significant differences in the occurrence of cardiac ADRs in patients exposed to CAP and 5-FU treatments, and in particular MI and HF. Compared to 5-FU, which could produce cardiac arrythmias with a higher probability than all other drugs, CAP has a higher probability of reporting this ADR only in comparison with IRI (ROR: 1.2971; 95% CI: 1.0196-1.6502). Conclusions: CAP induces adverse cardiovascular reactions, especially MI, HF, and cardiomyopathies. Arrhythmias have been shown to be side effects more frequent associated with 5-FU than with CAP. The results emphasize the need for a rigorous cardiovascular monitoring of patients following treatment with CAP or 5-FU and especially for those with pre-existing cardiac pathology.
卡培他滨（CAP）是肿瘤学领域最常用的氟尿嘧啶类药物之一，尤其在结肠癌治疗中应用广泛。心脏毒性是氟尿嘧啶类药物严重且可能致命的药物不良反应。已有报道显示这类药物可引起心肌梗死、心力衰竭、心律失常及多种心肌病等心脏不良反应。为更全面评估结肠癌治疗的风险获益比，有必要对实际使用中抗肿瘤药物心脏毒性的真实世界证据进行药物警戒研究。目的：本研究旨在通过上市后监测评估卡培他滨的心脏毒性风险，同时对比研究结直肠癌治疗中常用的其他五种抗肿瘤药物——5-氟尿嘧啶（5-FU）、伊立替康（IRI）、奥沙利铂（OX）、贝伐珠单抗（BEV）和帕尼单抗（PAN），以建立相对的心脏毒性特征谱。方法：基于截至2024年7月28日欧盟药物警戒数据库（EudraVigilance）中提交的报告进行回顾性研究。利用该数据库的汇总数据，对氟尿嘧啶类药物引发的心脏不良反应进行描述性分析和不成比例性分析。通过与5-FU、IRI、OX、BEV和PAN等其他结直肠癌治疗药物的对比，计算报告比值比（ROR）及95%置信区间（95% CI）以评估信号的不成比例性。结果：在卡培他滨的所有不良反应报告中，“心脏疾病”类占比为3.4%，该比例与5-FU相当，但高于其他药物。研究发现，接受卡培他滨与5-FU治疗的患者在心脏不良反应（特别是心肌梗死和心力衰竭）的发生率上无显著差异。相较于5-FU（其引发心律失常的概率高于所有其他药物），卡培他滨仅在对比伊立替康时显示出更高的心律失常报告概率（ROR：1.2971；95% CI：1.0196-1.6502）。结论：卡培他滨可诱发心血管不良反应，特别是心肌梗死、心力衰竭和心肌病。心律失常作为不良反应更多见于5-FU而非卡培他滨。研究结果强调，对接受卡培他滨或5-FU治疗的患者，尤其是有基础心脏疾病的患者，需要进行严格的心血管监测。
肿瘤(癌症)患者之家