Eribulin versus dacarbazine in patients with leiomyosarcoma: subgroup analysis from a phase 3, open-label, randomised study

Cancer research · Leiomyosarcoma

In patients with leiomyosarcoma, the efficacy of eribulin is comparable to that of dacarbazine, with no statistically significant difference in overall survival, progression‑free survival or objective response rate.

This subgroup analysis of a phase 3 study compares outcomes for eribulin versus dacarbazine in patients with leiomyosarcoma. Patients ≥18 years old with advanced leiomyosarcoma were randomly assigned (1:1) to eribulin mesylate or dacarbazine. The primary endpoint was overall survival (OS); secondary endpoints included progression‑free survival (PFS) and objective response rate (ORR). In the leiomyosarcoma cohort (n=309), the median OS was 12.7 months for eribulin versus 13.0 months for dacarbazine (HR = 0.93, 95% CI 0.71–1.20; P = 0.57). Median PFS was 2.2 versus 2.6 months (HR = 1.07, 95% CI 0.84–1.38; P = 0.58). ORR was 5% for eribulin and 7% for dacarbazine. Both agents had manageable safety profiles.

The results indicate that eribulin does not provide a clinically meaningful survival advantage over dacarbazine in leiomyosarcoma, underscoring the need for alternative therapeutic strategies and informing clinical decision‑making for patients with this rare sarcoma subtype.

Evidence level: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.

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