Multicenter phase 3 trial of addition of trabectedin to first-line doxorubicine for metastatic or unresectable leiomyosarcoma

Patients with metastatic leiomyosarcoma have a poor prognosis. Standard first-line treatment is doxorubicin. The multicenter phase 3 LMS-04 trial in France evaluated addition of trabectedin to first-line doxorubicin for metastatic or unresectable leiomyosarcoma. Doxorubicin plus trabectedin was found to significantly increase progression-free survival compared with doxorubicin alone (aHR 0,41; p=0,001), at the cost of a higher but manageable toxicity. The authors conclude that doxorubicin-trabectedin could be considered an option for the first-line treatment of metastatic leiomyosarcoma.