RT Journal Article SR Electronic T1 Abemaciclib-associated Diarrhea: An Exploratory Analysis of Real-life Data JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 1291 OP 1299 DO 10.21873/anticanres.16276 VO 43 IS 3 A1 VITTORIO GEBBIA A1 FEDERICA MARTORANA A1 MARIA VITA SANÒ A1 MARIA ROSARIA VALERIO A1 FRANCESCO GIOTTA A1 MASSIMILIANO SPADA A1 DARIO PIAZZA A1 MICHELE CARUSO A1 PAOLO VIGNERI YR 2023 UL http://ar.iiarjournals.org/content/43/3/1291.abstract AB Background/Aim: 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. Patients and Methods: 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. Results: 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. Conclusion: 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.