Abemaciclib是一种cyclin-dependent kinase 4/6抑制剂，通过与内分泌治疗结合治疗荷尔蒙受体阳性和人表皮生长因子受体2阴性的早期和晚期乳腺癌患者获得批准。Abemaciclib的安全性以频繁的胃肠毒性，尤其是腹泻为特征。因此，我们对可能与接受abemaciclib加内分泌治疗的患者腹泻潜在相关的临床因素进行了探索性分析。我们选择了可能导致腹泻的因素，如年龄≥70岁，伴随用药和疾病，饮食和泻药的使用。这些变量与一组接受abemaciclib治疗的晚期乳腺癌患者的2/3级腹泻的发生进行了相关性分析。进行了单变量和多变量分析。使用ROC曲线测试了灵敏度和特异度。该研究包括了80名晚期乳腺癌女性。单变量分析发现，年龄≥70岁、多药并用和伴随胃肠疾病与2/3级腹泻之间存在显著统计学关联（p<0.05）。在多变量分析中，风险因素的数量与感兴趣的结果存在显著相关性（p<0.0001）。ROC分析显示我们模型的灵敏度为82%，特异度为75%。考虑到特定的既往因素，可以估计荷尔蒙受体阳性和人表皮生长因子受体2阴性-晚期乳腺癌患者接受abemaciclib加内分泌治疗的腹泻风险。在这些患者中，实施积极的预防措施和采用剂量逐步增加的策略可能是减少abemaciclib毒性负担的实用方法。版权所有© 2023 International Institute of Anticancer Research（George J. Delinasios博士），保留所有权利。

Abemaciclib is a cyclin-dependent kinase 4/6 inhibitor approved in combination with endocrine therapy for treating hormone receptor-positive and human epidermal growth factor receptor 2-negative early and advanced breast cancer patients. The safety profile of abemaciclib is characterized by frequent gastrointestinal toxicity, especially diarrhea. Therefore, we performed an exploratory analysis of clinical factors that may be potentially associated with diarrhea in patients treated with abemaciclib plus endocrine therapy.Factors potentially predisposing to diarrhea were selected, such as age ≥70 years, concomitant medications and diseases, diet, and use of laxatives. These variables were correlated with the onset of grade 2/3 diarrhea in a cohort of patients treated with abemaciclib from advanced breast cancer. Univariate and multivariate analysis was performed. Sensitivity and specificity were tested using the ROC curve.Eighty women with advanced breast cancer were included in the study. The univariate analysis found a statistically significant correlation between grade 2/3 diarrhea and age ≥70 years, polypharmacy, and concomitant gastrointestinal diseases (p<0.05). In the multivariate analysis, the number of risk factors significantly correlated with the outcome of interest (p<0.0001). ROC analysis showed our model's 82% sensitivity and 75% specificity.Taking into account specific pre-existing factors, it is possible to estimate the risk of diarrhea in hormone receptor-positive and human epidermal growth factor receptor 2-negative - advanced breast cancer patients, candidates for abemaciclib plus endocrine therapy. In these subjects, implementing proactive prevention and adopting a dose-escalation strategy may represent practical approaches to decrease the abemaciclib toxicity burden.Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.