Use of everolimus in advanced hormone receptor–positive metastatic breast cancer in a multicenter national observational study.

Abstract

e12548 Background: The everolimus-exemestane combination has been included in the International guidelines for advanced HR+ breast cancer (mBC) since the results of the Bolero-2 trial. Marketing authorization has been granted in France in July 2012 and reimbursement in Nov. 2014. Very few real life data of everolimus (EVE) use have been reported. Methods: All patients who initiated treatment for a newly diagnosed mBC between Jan. 2008 and Dec. 2015 in all 18 French Comprehensive Cancer Centers have been included in the real life ESME database, which collects retrospective data using a clinical trial-like methodology with quality assessments. Primary endpoint of the current analysis was to evaluate the incidence and indication of EVE use before and after marketing authorization and reimbursement Results: The ESME program included a total of 16,703 patients of which 9,921 had HR+/HER2- mBC. Median age at metastatic diagnosis was 62.0 year (range 23-96). Visceral metastases were present in 60.3% of cases. Only 4123 patients (41.6%) received endocrine therapy alone as first-line therapy, and 60% were deemed endocrine resistant Overall, 1,217 (12.3%) pts have received EVE during therapy as of Dec. 2015 (all lines). EVE was given as first line therapy in 117 pts (10% of all EVE pts and 1.2% of pts receiving a first line therapy). In 99/117 pts (85%) EVE was combined with exemestane. Before 2012, EVE was barely used and mostly within clinical trials. After 2012, use of EVE increased steadily (table). Percentages refer to the total of pts who received any kind of treatment during a given year of observation (e.g., 506/4435 pts took EVE in 2015). Median duration of EVE use was 6.0 months (0-65) as first line treatment and 3.9 months (0-65) in pretreated patients. Main causes of EVE cessation were recorded and will be detailed at the meeting. Conclusions: In this very large French national and representative cohort of HR+ HER2- mBC, EVE use rose quickly as soon as marketed. EVE was mostly used in pretreated mBC albeit in probably too advanced pts. These data underline the need for physician and patient education for oral therapies. [Table: see text]