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Observational study of HR+/HER2- metastatic breast cancer patients treated with abemaciclib in Spain in the Named
Salvador Blanch1, Juan Miguel Gil-Gil2, Miriam Arumí3
1Instituto Valenciano de Oncología (IVO), Carrer del Professor Beltrán Báguena, 8, 46009, Valencia, Valencia, Spain.
Introduction/Objectives:
To 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 Methods:
This 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.
Results:
The 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%).
Conclusion:
These results suggest that abemaciclib is effective, as monotherapy and in combination, for patients with heavily pretreated mBC, consistent with clinical trial results.
Insights
Abemaciclib shows effectiveness in heavily pretreated hormone receptor-positive, human epidermal growth factor receptor-negative metastatic breast cancer patients. This study in Spain
Area of Science:
- Oncology
- Pharmacology
- Clinical Medicine
Background:
- Metastatic breast cancer (mBC) remains a significant health challenge, particularly the hormone receptor-positive, human epidermal growth factor receptor-negative (HR+/HER2-) subtype.
- Effective treatment options for patients with heavily pretreated HR+/HER2- mBC are crucial.
- Abemaciclib has emerged as a targeted therapy option.
Purpose of the Study:
- To evaluate the use and effectiveness of abemaciclib in patients with HR+/HER2- mBC.
- To describe treatment patterns and outcomes within the Spanish Named Patient Use (NPU) program.
- To analyze real-world data on abemaciclib in a heavily pretreated patient population.
Main Methods:
- Retrospective study analyzing medical records from 20 Spanish centers (2018-2019).
- Included 69 female patients with HR+/HER2- mBC, with follow-up until study end or other defined events.
- Kaplan-Meier method used for time-to-event and median time estimations.
Main Results:
- The study population had a median of 6 prior treatment lines before abemaciclib.
- Abemaciclib was used as monotherapy (72%) or in combination with endocrine therapy (28%).
- Median treatment duration was 7.7 months, with dose adjustments in 54% of patients, primarily due to disease progression.
Conclusions:
- Abemaciclib demonstrates effectiveness in heavily pretreated HR+/HER2- mBC patients, both as monotherapy and in combination.
- Real-world data from the Spanish NPU program align with findings from clinical trials.
- These results support abemaciclib's role in managing advanced metastatic breast cancer.
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