393P - Efficacy of eribulin in a second-line or later setting in patients (pts) with metastatic breast cancer (MBC): A pooled analysis

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer agents
Breast Cancer
Therapy
Biological Therapy
Presenter Christopher Twelves
Citation Annals of Oncology (2014) 25 (suppl_4): iv116-iv136. 10.1093/annonc/mdu329
Authors C. Twelves1, J. Cortes2, M. Olivo3, Y. He3, A. Awada4
  • 1Bexley Wing, Level 4, Leeds Institute of Cancer and Pathology and St James’s Institute of Oncology, LS9 7TF - Leeds/GB
  • 2Breast Cancer Program, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 3Oncology, Eisai Inc, Woodcliff Lake/US
  • 4Medical Oncology, Institute Jules Bordet, Brussels/BE

Abstract

Aim

Eribulin (E) is under review by the European Medicines Agency for use as a second-line and later therapy for pts with locally advanced/MBC who have advanced after prior chemotherapy. To assess the efficacy of E in this setting, we conducted pooled analyses of data from 2 phase 3 open-label studies in pts with locally advanced/MBC.

Methods

In study 1, pts who had received 0–2 chemotherapies for advanced disease were randomized 1:1 to E mesilate (1.4 mg/m2 iv on days 1 and 8 every 21 days) or capecitabine (1.25 g/m2 orally bid on days 1–14 every 21 days). In study 2, pts had received 2–5 chemotherapies, and were randomized 2:1 to E (as above) or treatment of physician's choice. For this analysis, overall survival (OS) was assessed by Cox regression and stratified log-rank tests for the overall intent-to-treat population and by HER2, HR and triple negative (TNBC) status.

Results

In all, 1644 pts (median age 55.0 yrs) were included, most in the 2nd (35.8%) or 3rd (37.0%) -line settings for advanced disease. E significantly improved OS vs control in the overall, HER2 − , HR+ and TNBC groups (Table). Similar OS data were seen in the HR− and non-TNBC groups (data not shown). E significantly improved progression-free survival (PFS) overall (3.9 vs 3.2 months; HR: 0.88; 95%CI: 0.78, 0.98; p = 0.020), and for HER2− (3.7 vs 2.9 months; HR: 0.84; 95% CI: 0.73, 0.96; p = 0.009), HR+ (4.1 vs 3.5 months; HR: 0.85; 95% CI: 0.73, 0.98; p = 0.028) and TNBC (2.8 vs 2.5 months; HR: 0.76; 95% CI: 0.60, 0.97; p = 0.026) but not HER2+ pts (3.8 vs 4.2 months; HR: 1.0; 95%CI: 0.75, 1.35; p = 0.970).

Overall HER2 − HER2 + HR + TNBC
E Con E Con E Con E Con E Con
n 946 698 663 497 150 104 574 432 199 153
Median OS,a months 15.1 12.5 15.1 12.0 13.5 11.7 15.7 13.5 12.4 8.1
HR (95% CI)b 0.84 (0.76, 0.94) 0.84 (0.74, 0.96) 0.75 (0.57, 1.00 0.85 (0.74, 0.99) 0.70 (0.55, 0.86)
pb 0.003 0.011 0.054 0.038 0.003

aBased on survival curves adjusted by study; bstratified by region, prior capecitabine use and study (and HER2 status for the overall group). E, eribulin; Con, control; HR, hazard ratio; OS, overall survival.

Conclusions

In this pooled analysis, E significantly improved OS in a second-line or later setting vs available therapies in the overall, HER2 − , HR + , HR − , TNBC and non-TNBC groups. Treatment differences were not significant in HER2+ pts, but there were fewer pts. Eribulin was thus superior to available therapies in a second-line or later setting in pts with locally advanced/MBC who have advanced after ≥ 1 chemotherapy for advanced disease.

Disclosure

C. Twelves: has disclosed a consultant or advisory role with Eisai for which he has been compensated. He has also received honoraria and other remuneration from Eisai; J. Cortes: has disclosed a consultant or advisory relationship with Novartis, Celgene and Roche for which he has been compensated. He has also received honoraria from Novartis, Celgene, Roche and Eisai; M. Olivo: Martin Olivo is an employee of Eisai Inc.; Y. He: Yi He is an employee of Eisai Inc. All other authors have declared no conflicts of interest.