Eribulin vs dacarbazine liposarcoma

Background

Open-label phase 3 trial of 452 patients with intermediate- or high-grade advanced liposarcoma or leiomyosarcoma who had received at least two prior systemic regimens including an anthracycline, comparing eribulin with dacarbazine.

Interventions and follow up

Arm A: Eribulin mesylate 1.4 mg/m2 days 1 and 8 q3wk
Arm B: Dacarbazine 850, 1000, or 1200 mg/m2 (per center/clinician) q3wk
Primary endpoint: Overall survival
Secondary endpoints: PFS, ORR, safety
mFollow up: 31 mo

Results

mOS (overall): 13.5 mo vs 11.5 mo; HR 0.77, 95%CI 0.62-0.95, P=.02
mOS liposarcoma: 15.6 mo vs 8.4 mo
mOS leiomyosarcoma: 12.7 mo vs 13.0 mo
mPFS: 2.6 mo vs 2.6 mo (no difference overall)

Adverse events

Overall grade ≥3: 63% vs 55% (eribulin vs dacarbazine)
Hematologic: neutropenia 35% vs 16%, leukopenia 10% vs 5%, anemia 7% vs 12%, thrombocytopenia <1% vs 15%
Non-hematologic: peripheral neuropathy and fatigue more frequent with eribulin

Conclusions

Eribulin significantly improved overall survival versus dacarbazine in advanced liposarcoma/leiomyosarcoma after anthracycline failure, with the benefit driven predominantly by the liposarcoma subgroup, supporting it as a later-line option.

Key Limitations

OS benefit limited to liposarcoma; no significant survival gain in leiomyosarcoma, yet trial enrolled both. No PFS improvement overall. Open-label design with variable dacarbazine dosing.

Clinical Context

Supported FDA approval (Jan 2016) of eribulin for unresectable/metastatic liposarcoma after anthracycline-containing therapy; ESMO recognizes eribulin as a standard later-line option specifically for liposarcoma.

References