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. We evaluated the incidence and indication of everolimus (EVE) use before and after marketing authorization and reimbursement.
All patients who initiated treatment for a newly diagnosed mBC between 01/2008 and 12/2015 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.
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 used within clinical trials. After 2012, use of EVE increased steadily. Percentages in the Table refer to the total of pts who received any kind of treatment during a given year of observation (eg 506 pts took EVE in 2015 out of 4435). Median duration of EVE use was 6.0 months (range 0-65) as first line treatment and 3.9 months (range 0-65) in pretreated patients. Patient population and causes of EVE cessation will be detailed at the meeting.Table:
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.
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All authors have declared no conflicts of interest.