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Utilization and outcomes of Eribulin Mesylate POst a cyclin-dependent kinase 4/6 inhibitor (CDK 4/6i): An observational real-World study in UnitEd States community oncology pRactices (EMPOWER)


03 May 2019


Poster lunch


Sarah Mougalian


Annals of Oncology (2019) 30 (suppl_3): iii47-iii64. 10.1093/annonc/mdz100


S. Mougalian1, E. Wang2, K. Alexis3, B.A. Feinberg4, D. Nero4, T. Miller4, J. Laney4, D. Chatterjee2, R. Knoth2, J. Kish4

Author affiliations

  • 1 Internal Medicine-medical Oncology, Yale Cancer Center, New Haven/US
  • 2 N/a, Eisai, Inc, Woodcliff Lake/US
  • 3 N/a, Eisai Inc, NJ 07677 - Woodcliff Lake/US
  • 4 N/a, Cardinal Health Specialty Solutions, Dallas/US



As CDK 4/6i therapy becomes the standard of care in the early-line treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−), metastatic breast cancer (mBC), this study evaluated the safety and effectiveness of eribulin mesylate when used post-CDK 4/6i treatment.


This was a retrospective, observational cohort study. Providers from community oncology practices in the United States selected female HR+, HER2− patients with MBC who were treated with any CDK 4/6i from Feb/03/15-Dec/31/17, and who subsequently initiated eribulin post-CDK 4/6i treatment. Patients were assigned to 1 of 3 protocol-defined treatment groups: “on-label” was defined as eribulin post-CDK4/6i treatment, >2 prior chemotherapies in the metastatic setting, and treatment with an anthracycline and taxane prior to eribulin; “third-line” (3L) was eribulin following treatment with a CDK4/6i and any other regimen; “other” was neither on-label nor 3L. Adverse events (AEs), objective response rate (ORR) per RECIST v1.1 guidelines, and time to progression during eribulin treatment were compared to findings from the registrational EMBRACE trial.


395 Patients were selected by 45 providers: on-label n = 135 patients, 3L n = 111, and other n = 149 (n = 121 with second-line eribulin [“other-2L”]) (Table). Based on target lesion measurements, the ORR in the on-label cohort was 26.7%, or twice that observed in EMBRACE (13%). Time to progression was similar to the EMBRACE median progression-free survival (PFS) estimate. Reported grade 3/4 AE rates were lower than in EMBRACE (neutropenia=8.1% vs 45%; peripheral neuropathy=0.5% vs 9%).


The results shown here for eribulin post-CDK4/6i were similar to those in the EMBRACE study. Longer follow-up will be needed to fully evaluate its influence on PFS and OS.

Table: 167P

n = 395n = 135n = 111n = 121
Stage IV at diagnosis, %63.557.857.776.9
Visceral metastases, %87.392.691.086.8
Easter Cooperative Oncology Group-performance status ≥ 2, %23.020.718.923.1
Mean duration of CDK 4/6i treatment (months)
Still receiving eribulin,%77.584.485.667.8
Median duration of eribulin (months)
AE (grade 3/4)*, %
Any febrile neutropenia1.
Peripheral neuropathy0.
Discontinuation due to toxicity, %
ORR, %30.626.726.142.4
Median time to progression (months)
12-Months survival from eribulin start§, %73.354.377.588.4

Per provider report.

Response Evaluation Criteria In Solid Tumors version 1.1.

Among patients with progression (55 patients).


60 Deaths.

Includes 28 “other non-2L”.

Editorial acknowledgement

Tarah Connolly of Oxford PharmaGenesis, Newtown, PA, USA.

Clinical trial identification

Legal entity responsible for the study

Eisai, Inc.


Eisai, Inc.


K. Alexis, D. Chatterjee R. Knoth: Employee: Eisai, Inc, Woodcliff Lake, NJ. B.A. Feinberg, D. Nero, T. Miller, J. Laney, J. Kish: Employee: Cardinal Health Specialty Solutions, Dallas, TX. All other authors have declared no conflicts of interest.

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