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Subgroup analysis of leiomyosarcoma (LMS) patients (pts) from a phase 3, open-label, randomized study of eribulin (ERI) versus dacarbazine (DTIC) in pts with advanced liposarcoma (LPS) and LMS

Date

10 Oct 2016

Session

Sarcoma

Presenters

Jean-Yves Blay

Citation

Annals of Oncology (2016) 27 (6): 483-492. 10.1093/annonc/mdw388

Authors

J. Blay1, P. Schoffski2, S. Bauer3, A. Krarup-Hansen4, C. Benson5, D.R. D'Adamo6, M. Guo7, R. Maki8

Author affiliations

  • 1 Université Claude Bernard, Centre Léon Bérard, 69008 - Lyon/FR
  • 2 Department Of General Medical Oncology, University Hospitals Leuven, B-3000 - Leuven/BE
  • 3 West German Cancer Center, University of Duisburg-Essen, 45122 - Essen/DE
  • 4 Department Of Oncology, Herlev Hospital-University of Copenhagen, Herlev/DK
  • 5 Sarcoma Unit, Royal Marsden Hospital NHS Foundation Trust, London/GB
  • 6 Eisai, Inc., Woodcliff Lake/US
  • 7 Eisai, Inc., 07677 - Woodcliff Lake/US
  • 8 Tisch Cancer Institute, Mount Sinai Medical Center, New York/US
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Resources

Background

A phase 3 study (Schöffski et al. Lancet 2016) comparing ERI with DTIC in pts with advanced LPS or LMS, showed significant improvement in overall survival (OS) for the ERI arm with a manageable toxicity profile. This subgroup analysis evaluated the efficacy and safety of ERI in LMS pts.

Methods

Pts aged ≥18 yrs with histologically confirmed, advanced LMS, and from 3 geographic regions, were included. Pts with ECOG status ≤2 and ≥2 prior systemic treatment regimens, including an anthracycline, were randomized 1:1 to ERI (1.4 mg/m2, IV, on Day [D] 1 and D8) or DTIC (850, 1000, or 1200 mg/m2, IV, on D1) every 21D until disease progression. OS, progression free survival (PFS), and safety were analyzed in the LMS subgroup.

Results

309 Pts with LMS (81% female; 80% 2 prior regimens (146 pts; 12.6 vs 11.5 mo, respectively, HR = 0.77 [95% CI 0.53–1.13]), with non-uterine disease (177 pts; 14.4 vs 13.2 mo respectively, HR = 0.77 [95% CI 0.54–1.09]), and enrolled in geographic region 1 (USA & Canada; 123 pts; 15.3 vs 13.0 mo, respectively, HR = 0.71 [95% CI 0.47–1.09]). PFS in LMS pts for ERI vs DTIC was similar (2.2 vs 2.6 mo, HR = 1.07, [95% CI 0.84–1.38]). In the LMS subgroup, response rates were 5.1% and 7.2% in the eribulin and DTIC arms, respectively. In the ERI and DTIC arms, 99% and 98% of LMS pts had adverse events (AEs). Most frequent AEs in the ERI arm were neutropenia (46%), fatigue (46%), nausea (41%), and alopecia (33%). In the ERI and DTIC arms, 40% and 38% had grade (G) 3 AEs, 25% and 18% had G4 AEs, and 5% and 2% had G5 AEs.

Conclusions

In LMS pts, ERI was associated with activity comparable to the active drug DTIC. Outcome heterogeneity within the LMS subgroup may represent random variation or biologic differences in this sarcoma subtype.

Clinical trial identification

NCT01327885

Legal entity responsible for the study

Eisai Inc

Funding

Eisai Inc

Disclosure

J-Y. Blay: Honoraria: Novartis, GSK, Bayer, Roche, Pharmamar. Consulting/Advisory Role: Novartis, GSK, Bayer, Roche, Pharmamar. Research Funding: Novartis, GSK, Roche, Pharmamar. P. Schoffski: Consulting: Swedish Orphan Biovitrium, Blueprint Medicines, Bayer, Boehringer Ingelheim, Piqur Therapeutics, Eisai, Eli Lilly, Adaptimmune, AstraZeneca, Philogen, Amcure, Novartis, Cristal Therapeutics. S. Bauer: Membership on an advisory board or Board of Directors: Blueprint Medicine, Lilly, Novartis, Pfizer, Bayer Corporate-sponsored research: Novartis, Ariad. C. Benson: Corporate-sponsored research: Investigator on company sponsored trials including Novartis, PharmaMar, Lilly. D.R. D'Adamo: Employment: Eisai Inc. Travel/Accommodations: Eisai Inc. M. Guo: Employment: Eisai Inc. Stock Ownership: Amgen Travel: Eisai Inc. R. Maki: Research Funding, Honoraria, Consulting: Eisai/Morphotek. All other authors have declared no conflicts of interest.

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