Poster Presentation Joint 2016 COSA and ANZBCTG Annual Scientific Meeting

Subtype-specific activity in liposarcoma (LPS) patients (pts) from a phase 3, open-label, randomized study of eribulin (ERI) versus dacarbazine (DTIC) in pts with advanced LPS and leiomyosarcoma (LMS). (#230)

Sant Chawla 1 , Patrick Schöffski 2 , Giovanni Grignani 3 , Jean-Yves Blay 4 , Robert G Maki 5 , David R D'Adamo 6 , Mile Janevski 7 , Matthew Guo 6 , George D Demetri 8
  1. Sarcoma Oncology Centre, Santa Monica, CA, USA
  2. Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium
  3. Department of Medical Oncology, Fondazione del Piemonte per l’Oncologia IRCC, Candiolo, Torino, Italy
  4. Université Claude Bernard & Centre Léon Bérard, Lyon, France
  5. Tisch Cancer Institute, Mount Sinai Medical Center, New York, NY, USA
  6. Eisai Inc., Woodcliff Lake, NJ, USA
  7. Eisai Australia, Melbourne, VIC, Australia
  8. Sarcoma Center and Ludwig Center, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA

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

Methods: Pts aged ≥18 yrs with advanced dedifferentiated, myxoid, round cell, or pleomorphic LPS incurable by multimodality therapy 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 D1 and D8) or DTIC (850, 1000, or 1200 mg/m2, IV on D1) every 21-D until disease progression. OS, progression free survival (PFS), and safety were evaluated.

Results: 143 pts with LPS (45% dedifferentiated, 39% myxoid/round cell, 16% pleomorphic), representing 32% of the total study population, were included in this pre-planned analysis (71 ERI; 72 DTIC). Median OS for LPS pts receiving ERI vs DTIC was 15.6 vs 8.4 mo (HR=0.51, [95% CI 0.35 0.75]; P=0.001). OS benefit with ERI vs DTIC was observed independent of LPS histology (dedifferentiated—18.0 vs 8.1 mo, HR=0.43 [95% CI 0.23, 0.79]; myxoid/round cell—13.5 vs. 9.6 mo, HR=0.79 [95% CI 0.42, 1.49]; pleomorphic—22.2 vs 6.7 mo, HR=0.18 [95% CI 0.04, 0.85]) and geographic region. PFS in LPS pts for ERI vs DTIC was improved (2.9 vs 1.7 mo, HR=0.52, [95% CI 0.35–0.78]; P=0.002).

The mean number of treatment cycles for ERI vs DTIC was 6.5 and 3.2, respectively. Most frequent AEs in the ERI arm were alopecia (40%), fatigue (40%), and neutropenia (39%). AEs of ≥grade 3 occurred in 63% and 51% of LPS pts in the ERI and DTIC arms, respectively.

Conclusions: ERI was associated with a significant benefit in OS and PFS compared with DTIC in LPS pts and represents an active agent against LPS.