血栓形成可能包含在与 CDK4/6 抑制剂相关的副作用中。其意义可能比随机临床试验中报告的更重要。为了调查这一点，进行了一项回顾性、多中心研究。主要目的是计算与 CDK4/6 抑制剂相关的血栓形成的发生率。次要目标包括检查血栓形成对生存的影响以及确定静脉血栓栓塞（VTE）或动脉血栓形成（AT）发展的预测变量。总共招募了 986 名患者。随访期间与CDK4/6抑制剂治疗相关的VTE/AT发生率为5.48%。生存分析并未表明 CDK4/6 抑制剂治疗期间 VTE/AT 的发生显着影响患者生存 (p = 0.133)。在我们的分析中，发现两个变量作为接受 CDK4/6 抑制剂治疗的乳腺癌患者的 VTE/AT 预测因子具有统计显着性 (p < 0.05)。这些变量是中枢神经系统 (CNS) 转移的存在，比值比 (OR) 为 3.68 (95% CI 1.18 - 11.49)，以及 abemaciclib 的使用，比值比为 2.3 (95% CI 1.16 - 4.57)。版权© 2024。由 Elsevier B.V. 出版

Thrombosis may be included in the profile of side effects associated with CDK4/6 inhibitors. Its significance might be greater than reported in randomized clinical trials. To investigate this, a retrospective, multicenter study was conducted. The primary objective was to calculate the incidence of thrombosis associated with CDK4/6 inhibitors. Secondary objectives included examining the impact of thrombosis on survival and identifying predictor variables for the development of venous thromboembolism (VTE) or arterial thrombosis (AT). A total of 986 patients were recruited. The incidence of VTE/AT associated with CDK4/6 inhibitor treatment during the follow-up period was 5.48 %. Survival analysis did not indicate that the development of VTE/AT during CDK4/6 inhibitor treatment significantly impacted patient survival (p = 0.133). In our analysis, two variables were found to be statistically significant (p < 0.05) as predictors of VTE/AT in breast cancer patients receiving CDK4/6 inhibitor therapy. These variables were the presence of central nervous system (CNS) metastasis with an odds ratio (OR) of 3.68 (95 % CI 1.18 - 11.49) and the use of abemaciclib with an OR of 2.3 (95 % CI 1.16 - 4.57).Copyright © 2024. Published by Elsevier B.V.