Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• Overall Survival (OS) in Total STS (soft tissue sarcoma) Population: The median OS was 20.4 months for patients receiving doxorubicin plus olaratumab and 19.7 months for those receiving doxorubicin plus placebo, with a hazard ratio of 1.05 (95% CI (confidence interval), 0.84–1.30; P = .69), indicating no statistically significant difference in OS between the treatment groups.
• Overall Survival (OS) in Leiomyosarcoma (LMS) Population: Median OS was 21.6 months for doxorubicin plus olaratumab and 21.9 months for doxorubicin plus placebo, with a hazard ratio of 0.95 (95% CI, 0.69–1.31; P = .76), showing no statistically significant difference in OS in this subgroup.
• Subgroup Analysis: In the study population of anthracycline-naive adults with advanced or metastatic STS, no significant OS difference was observed between the total STS group and the LMS subgroup when comparing doxorubicin plus olaratumab with doxorubicin plus placebo.
• In the total STS population, adverse events of grade 3 or higher were reported, with neutropenia observed in 46.3% of patients receiving doxorubicin plus olaratumab and 49.0% in the doxorubicin plus placebo group. Leukopenia occurred in 23.3% and 23.7% of patients, respectively, and febrile neutropenia was reported in 17.5% of patients with olaratumab and 16.5% with placebo.
• No significant new safety concerns were noted, as adverse event rates were comparable between the doxorubicin plus olaratumab and doxorubicin plus placebo groups.
• The study included anthracycline-naive adults with unresectable locally advanced or metastatic STS with an ECOG performance status of 0 to 1 and cardiac ejection fraction of 50% or higher, with a subgroup analysis for leiomyosarcoma (LMS) showing no significant difference in overall survival compared to the total STS population.