Abstract
BackgroundThis subgroup analysis of a phase 3 study compares outcomes for eribulin versus dacarbazine in patients with leiomyosarcoma.MethodsPatients ≥18 years old with advanced liposarcoma or leiomyosarcoma, ECOG PS ≤2, and ≥2 prior treatment regimens were randomly assigned (1:1) to eribulin mesylate (1.4 mg/m² intravenously on day 1 and day 8) or dacarbazine (either 850, 1000, or 1200 mg/m² intravenously) every 21 days until disease progression. The primary end point was OS; additional end points were progression-free survival (PFS) and objective response rate (ORR).Results309 Patients with leiomyosarcoma were included (eribulin, n = 157; dacarbazine, n = 152). Median age was 57 years; 42% of patients had uterine disease and 57% had nonuterine disease. Median OS was 12.7 versus 13.0 months for eribulin versus dacarbazine, respectively (hazard ratio [HR] = 0.93 [95% CI 0.71–1.20]; P = 0.57). Median PFS (2.2 vs 2.6 months, HR = 1.07 [95% CI 0.84–1.38]; P = 0.58) and ORR (5% vs 7%) were similar between eribulin- and dacarbazine-treated patients. Grade ≥3 TEAEs occurred in 69% of patients receiving eribulin and 59% of patients receiving dacarbazine.ConclusionsEfficacy of eribulin in patients with leiomyosarcoma was comparable to that of dacarbazine. Both agents had manageable safety profiles.
Highlights
This subgroup analysis of a phase 3 study compares outcomes for eribulin versus dacarbazine in patients with leiomyosarcoma
We present the results from a histology-driven subgroup analysis of patients with LMS from a large-scale, prospective, randomised, controlled, phase 3 study comparing the efficacy and safety of eribulin to dacarbazine in previously treated patients with advanced STS of two histologically distinct types: LMS and LPS.[18]
The phase 3 study was not designed to be a noninferiority trial. In this subgroup analysis of patients with LMS, median overall survival (OS) was comparable between patients treated with eribulin versus dacarbazine (HR = 0.93; 95% confidence intervals (CIs) [0.71–1.20])
Summary
Soft tissue sarcomas (STSs) consist of a heterogeneous group of mesenchymal tumours and comprise numerous histologically distinct subtypes that affect various primary sites. STS types are rare, with an incidence rate of 3–5 cases per 100,000 persons per year.[1,2] Liposarcoma (LPS) and leiomyosarcoma (LMS) are two of the more frequently observed sarcoma subtypes, both of which are further categorised based on distinctive clinical and pathologic features.[2,3,4] LMS represents. For unresectable or metastatic disease, anthracycline-based chemotherapy is the recommended first-line treatment, with variations in practice between use of doxorubicin as a single agent or in combination with other agents (typically with olaratumab, ifosfamide, or dacarbazine).[6,7,8] Dacarbazine has shown single-agent activity and improved efficacy in combination with doxorubicin in patients with LMS.[9] In a randomised phase 1b/2 trial in anthracycline-naive patients with advanced STS, the combination of doxorubicin and olaratumab significantly improved overall survival (OS) compared with doxorubicin alone. We present the results of a histology-driven analysis of the efficacy and safety of eribulin in patients with LMS, a randomised and stratified subgroup enrolled in the phase 3 study
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