Observational study of HR+/HER2-metastatic breast cancer patients treated with abemaciclib in Spain in the Named Patient Use Program (AbemusS)

Introduction/objectivesTo describe abemaciclib use in patients with hormone receptor-positive, human epidermal growth factor receptor-negative (HR+/HER2-) metastatic breast cancer (mBC) who participated in the Named Patient Use program (NPU) in Spain.Material and methodsThis retrospective study was...

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Bibliographic Details
Authors: Blanch, S, Gil-Gil, JM, Arumi, M, Aguirre, E, Segui, MA, Atienza, M, Diaz-Cerezo, S, Molero, A, Cervera, JM, Gavila, J
Format: article
Status:Published version
Publication Date:2023
Country:España
Institution:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repository:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p2491
Online Access:https://i3pt.portalinvestigacion.com/publicaciones/2491
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85151980121&doi=10.1007%2fs12094-023-03159-9&partnerID=40&md5=bcd48fdf8d5b263fe27fb83ead8e6487
Access Level:Open access
Keyword:Metastatic breast cancer
Abemaciclib
Effectiveness
Real world
HR plus
HER2-Spain
Description
Summary:Introduction/objectivesTo describe abemaciclib use in patients with hormone receptor-positive, human epidermal growth factor receptor-negative (HR+/HER2-) metastatic breast cancer (mBC) who participated in the Named Patient Use program (NPU) in Spain.Material and methodsThis retrospective study was based on medical record review of patients across 20 centers during 2018/2019. Patients were followed up until death, enrolment in a clinical trial, loss of follow-up or study end. Clinical and demographic characteristics, treatment patterns and abemaciclib effectiveness were analyzed; time-to-event and median times were estimated using the Kaplan-Meier (KM) method.ResultsThe study included 69 female patients with mBC (mean age 60.4 +/- 12.4 years), 86% of whom had an initial diagnosis of early BC and 20% had an ECOG >= 2. Median follow-up was 23 months (range 16-28). Metastases were frequently observed in bone (79%) and visceral tissue (65%), with 47% having metastases in > 2 sites. Median number of treatment lines before abemaciclib was 6 (range 1-10). Abemaciclib monotherapy was received by 72% of patients and combination therapy with endocrine therapy by 28% of patients; 54% of patients required dose adjustments, with a median time to first adjustment of 1.8 months. Abemaciclib was discontinued in 86% of patients after a median of 7.7 months (13.2 months for combination therapy and 7.0 months for monotherapy) mainly due to disease progression (69%).ConclusionThese results suggest that abemaciclib is effective, as monotherapy and in combination, for patients with heavily pretreated mBC, consistent with clinical trial results.