EUFORIA study (Eribulin Use for the Treatment of Advanced Breast Cancer: Observational, Retrospective Analysis): Initial experience with eribulin in daily clinical practice in Spain.

Abstract

e12015 Background: Spanish MoH authorized eribulin in 04/2011 for use in patients as per license. Pending reimbursement, public hospitals used it through a national compassionate use program. After 1 year, we analyzed the pre-specified patient selection criteria and eribulin efficacy and safety results in a representative sample to confirm whether real world use matched the data from the pivotal phase III study. Methods: An observational, retrospective analysis was proposed to the top 20 hospitals by eribulin use, with at least 3 candidate patients who had/could have received ≥3 cycles of treatment by 03/2012. Patient and disease characteristics, as well as efficacy and safety parameters were obtained. Patient´s data were collected until September 2012. Living patients able to respond at the time of the study signed an informed consent. Study was approved by ethics committees. Results: Out of 112 screened ABC patients in 19 participating hospitals, 104 were enrolled. Median age was 56.6 years and 66% were post-menopausal. Visceral disease occurred in 2/3 of patients. ECOG status was ≤1 in 75,4% of patients. Estrogen receptor expression was found in 64.4% of tumors; 15.4% overexpressed HER2. 49% of patients received 1-5 treatment lines for ABC before eribulin. Mean eribulin treatment duration was 3 months (4,7 cycles). Disease control rate was 48.8% (1.1% CR, 22.1% PR, 25.6% SD). By 09/2012, 64,4% patients were still alive and median PFS was 97 days (95% IC: 81-129). 78.8% of patients reported ≥1 adverse events, being asthenia, neutropenia, anemia, alopecia, nauseas, and mucositis the most frequent ones (≥10%). Grade ≥3 adverse events occurred in ≤5% of patients. Conclusions: The favorable efficacy and safety profile of eribulin observed in this observational study is consistent with the pivotal phase III study (EMBRACE) and confirms its position for the treatment of ABC. Pre reimbursement usage has been restricted to later lines but use per the licensed indication in 3L is expected to yield additional clinical benefit. A confirmatory observational study (EUFORIA-2) is planned.