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The administration of proton pump inhibitors with the CDK4/6 inhibitor abemaciclib does not affect the clinical outcome of metastatic breast cancer patients

Stefania Crucitta, Paola Cinacchi, Irene Bargagna, Pamela Biondani, Elena Giontella, Michela Palleschi, Claudia Omarini, Lorenzo Belluzzi et al.

Therapeutic Advances in Drug Safety, 2026

Abstract

Background: CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib have rapidly become an established oral treatment for patients with ER+, HER2- locally advanced or metastatic breast cancer. The use of the oral route offers convenience and flexibility to the patient; however, the co-administration of proton pump inhibitors (PPIs) to mitigate gastrointestinal adverse events induced by anticancer treatments may decrease drug solubility, bioavailability, and potentially impact treatment efficacy. Objectives: The present study was aimed at investigating whether PPIs may affect the progression-free survival (PFS) of patients treated with abemaciclib. Design: Multicenter observational cohort study on clinical data collected retrospectively. Methods: Patients with ER-positive/HER2-negative mBC candidates for a first-line treatment with abemaciclib as per clinical practice were enrolled. Patients were classified as "no concomitant PPIs" or "concomitant PPIs" if PPI administration covered not less than 2/3 of the treatment period with abemaciclib. All clinical interventions were made according to clinical practice. Results: = 0.77). Likewise, no difference in PFS was observed in endocrine-sensitive or -resistant mBC in the presence or absence of concomitant PPI treatment. No correlation with adverse events, including hematological or gastrointestinal toxicities, was found. Conclusion: This study demonstrates that the administration of PPIs to patients treated with abemaciclib is…

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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.

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