Abstract P6-14-02: Real-life activity of eribulin among metastatic breast cancer patients in the multicenter national observational ESME program
Authors: Jacot W , Heudel P-E , Fraisse J , Gourgou S , Guiu S , Dalenc F , Pistilli B , Campone M , Levy C , Debled M , Leheurteur M , Chaix M , Lefeuvre C , Goncalves A , Uwer L , Ferrero J-M , Eymard J-C , Petit T , Mouret-Reynier M-A , Courtinard C , Cottu P , Robain M , Mailliez A 
Published: February 2018

Abstract
Background: In 2014, UNICANCER (composed of 18 French Comprehensive Cancer Centers) launched the Epidemiological Strategy and Medical Economics (ESME) program to investigate real-world data in solid tumors. Real-world data give the opportunity to assess for the activity of specific drugs outside clinical trials. Eribulin is approved for pre-treated metastatic breast cancer (MBC). Marketing authorization has been granted in France in July 2012. However few data are available regarding its efficacy in real life. We evaluated eribulin use as second and third line of chemotherapy in MBC patients from the ESME database.
Methods: Data from all newly diagnosed MBC patients having initiated at least one treatment between Jan. 2008 and Dec. 2014 are included in the ESME database. Data were collected retrospectively using a clinical trial-like methodology. Primary endpoint was overall survival (OS), defined from the starting date of second or third line chemotherapy (eribulin versus other chemotherapy). Progression-free survival (PFS) was calculated as a secondary endpoint.
Results: Of 16,703 MBC patients included in the ESME database, 7,412 received at least 2 lines of chemotherapy: eribulin/other chemotherapy, total 1,966/5,446, second line 363/5,446, third line 654/2,669. Depending on second or third line chemotherapy use classification, median age was 59 years (range 20-97) and 58 year (range 21 – 94), triple negative tumors accounted for 20% and 19% of cases, and median follow-up reached 26 months and 22 months respectively.
Table reports median OS and PFS, according to lines and type of chemotherapy.
OS eribulin (months)OS other chemotherapy (months)pPFS Eribulin (months)PFS other chemotherapy (months)pSecond line12.4 (11.3-15.1)11.8 (11.3-12.3)0.4654.1 (3.7-4.9)4.1 (4.0-4.3)0.9225Third line10.3 (9.3-11.5)7.7 (7.3-8.0)&lt;.00013.6 (3.2-3.9)3.0 (2.9-3.2)0.0058
Supportive analyses (using a propensity score for adjustment and as a matching factor for nested case–control analyses) and sensitivity analyses will be available for full presentation at the meeting.
Conclusion: In this large-scale real-life setting, MBC patients treated with third line eribulin showed an improved OS and PFS compared with those receiving another chemotherapy. The difference was not statistically significant for second line treatment.
Citation Format: Jacot W, Heudel P-E, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero J-M, Eymard J-C, Petit T, Mouret-Reynier M-A, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin among metastatic breast cancer patients in the multicenter national observational ESME program [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-14-02.