Treatment of leiomyosarcoma

In an open-label study of trabectedin in adult patients with recurrent sarcomas, the best overall response rate (complete remission and partial remission) was seen in patients with leiomyosarcoma (7.5%).[3] The clinical benefit rate (included stable disease) was 54% for patients with leiomyosarcoma.

In another adult study, patients with recurrent liposarcoma and leiomyosarcoma were randomly assigned to receive treatment with either trabectedin or dacarbazine. Patients treated with trabectedin had a 45% reduction in disease progression.[4]

The French Sarcoma group conducted a randomized trial for the treatment of adult patients with leiomyosarcoma (age range, 52–69 years).[5] Patients were randomly assigned to receive either single-agent doxorubicin (six cycles) or doxorubicin with trabectedin, with continued maintenance therapy using trabectedin for patients in the doxorubicin/trabectedin group who did not have disease progression. Surgery to resect residual disease was allowed in each group after six cycles of therapy. The median overall survival was longer in the doxorubicin/trabectedin group (33 months; 95% confidence interval [CI], 26–48) than in the doxorubicin group (24 months; 95% CI, 19–31). The adjusted hazard ratio for death was 0.65 (95% CI, 0.44–0.95).