Doxorubicin + trabectedin tied to increased survival in metastatic leiomyosarcoma

For patients with metastatic or surgically unresectable leiomyosarcoma, combination therapy with doxorubicin and trabectedin is associated with improved overall and progression-free survival compared with doxorubicin alone, according to a study published online Sept. 4 in the New England Journal of Medicine.

Patricia Pautier, M.D., from the Institut Gustave-Roussy in Villejuif, France, and colleagues conducted a Phase III trial involving 150 patients with metastatic or unresectable leiomyosarcoma who had not received chemotherapy.

Patients were randomly assigned to doxorubicin (six cycles) or doxorubicin plus trabectedin (six cycles), with continued trabectedin as maintenance therapy in patients in the doxorubicin-trabectedin group without disease progression. After six cycles of therapy, surgery was allowed to resect residual disease in each group.

The researchers found that at a median follow-up of 55 months, 47 and 60 patients in the doxorubicin-trabectedin and doxorubicin groups, respectively, had died. Median overall survival was longer in the doxorubicin-trabectedin group versus the doxorubicin group (33 versus 24 months; adjusted hazard ratio for death, 0.65).

Progression-free survival was longer in the doxorubicin-trabectedin group versus the doxorubicin group, in a finding consistent with earlier reports (12 versus six months; adjusted hazard ratio for progression or death, 0.37).

"The trial results support the use of doxorubicin plus trabectedin for the first-line treatment of advanced or metastatic leiomyosarcomas, offering hope for improved outcomes in this challenging disease area," the authors write.

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