38.4% of patients with colorectal cancer died from non-cancer disease, with cardiovascular disease being the most important cause, accounting for 20.3% of the total deaths. Cardiovascular toxicity associated with targeted therapy is not uncommon, most notably hypertension.

The study aimed to determine the overall incidence and risk of cardiovascular toxicity associated with fruquintinib in metastatic colorectal cancer.

We searched CNKI, Wanfang Data, CBM, PubMed, Embase, Web of Science and Cochrane Library databases for single-arm clinical trials and randomized controlled trials (RCTs) relevant to fuquintinib therapy in patients with metastatic colorectal cancer. The search time limit was from the establishment of the databases to May 2024. Literature screening, data extraction, and quality evaluation were performed independently by two investigators. The meta-analysis was conducted using R 4.3.3 software.

Eight articles involving six single-arm clinical trials and three randomized controlled trials were included. The meta-analysis results showed that the incidence rates of all-grade hypertension and hemorrhage were 35% (95%CI=0.25-0.45) and 24% (95%CI=0.10-0.37), respectively. For high-grade events, the rates were 15% for hypertension (95%CI=0.10-0.20), 1% for hemorrhage (95%CI=0-0.02), 3% for embolic and thrombotic events (95%CI=0.02-0.05), and 1% for cardiac diseases (95%CI=0-0.02). Fruquintinib was associated with increased risks for both all-grade and high-grade hypertension, as well as all-grade hemorrhage, with RR of 3.93 (95%CI=2.95-5.24), 12.33 (95%CI=5.31-28.63), and 1.84 (95%CI=1.36-2.50) respectively, but not for high-grade hemorrhage (RR=1.06, 95%CI=0.35-3.23), embolic and thrombotic events (RR=3.35, 95%CI=0.89-12.55), or cardiac diseases (RR=0.62, 95%CI=0.18-2.14) .

The use of fruquintinib is associated with a significantly increased risk of developing cardiovascular toxicity, primarily for lower-grade events, in patients with metastatic colorectal cancer.

38.4%的结直肠癌患者死于非癌症疾病，其中心血管疾病是最主要原因，占总死亡人数的20.3%。靶向治疗相关的心血管毒性并不少见，最突出的为高血压。

本研究旨在探讨转移性结直肠癌患者呋喹替尼治疗相关心血管毒性的发生率和风险。

系统检索中国知网、万方数据知识服务平台、中国生物医学文献数据库、Web of Science、PubMed、Cochrane Library、Embase数据库中有关转移性结直肠癌患者呋喹替尼治疗的单臂临床试验和随机对照试验，检索时限为建库至2024年5月。由2名研究者独立进行文献筛选、资料提取及质量评价，使用R 4.3.3软件进行Meta分析。

共纳入8篇文献，涉及6项单臂临床试验、3项随机对照试验。Meta分析结果显示：全级别高血压和出血的发生率为35%（95%CI=0.25~0.45）和24%（95%CI=0.10~0.37）。在高级别事件中，高血压发生率为15%（95%CI=0.10~0.20），出血发生率为1%（95%CI=0~0.02），血栓栓塞发生率为3%（95%CI=0.02~0.05），心脏疾病发生率为1%（95%CI=0~0.02）。呋喹替尼与全级别、高级别高血压及全级别出血的风险增加相关，RR分别为3.93（95%CI=2.95~5.24）、12.33（95%CI=5.31~28.63）及1.84（95%CI=1.36~2.50），但与高级别的出血（RR=1.06，95%CI=0.35~3.23）、血栓栓塞事件（RR=3.35，95%CI=0.89~12.55）及心脏疾病（RR=0.62，95%CI=0.18~2.14）无关。

呋喹替尼与转移性结直肠癌患者心血管毒性发生率和风险增加显著相关，但主要针对的是低级别事件。