Doxorubicin/Trabectedin Boosts Survival in Metastatic Leiomyosarcoma

For individuals suffering from metastatic or surgically unresectable leiomyosarcoma, a combination treatment using doxorubicin and trabectedin shows significant improvements in both overall survival and progression-free survival when compared to using doxorubicin alone. This finding comes from a study published on September 4 in the New England Journal of Medicine.

The research, led by Dr. Patricia Pautier from the Institut Gustave-Roussy in Villejuif, France, involved a phase 3 clinical trial. The trial included 150 patients diagnosed with metastatic or unresectable leiomyosarcoma who had not yet undergone chemotherapy. Participants were randomly assigned to receive either doxorubicin alone for six cycles or a combination of doxorubicin and trabectedin for the same duration. For those in the doxorubicin-trabectedin group whose disease did not progress, trabectedin was continued as a maintenance therapy. Additionally, surgery to remove remaining disease was permitted after six cycles of treatment in both groups.

With a median follow-up period of 55 months, the study revealed that 47 patients in the doxorubicin-trabectedin group had died, compared to 60 in the doxorubicin-only group. The median overall survival was notably higher in the group receiving the combination therapy, standing at 33 months, compared to 24 months for those receiving just doxorubicin, with an adjusted hazard ratio for death at 0.65. Progression-free survival also favored the doxorubicin-trabectedin group, showing a median of 12 months versus six months in the doxorubicin group, with an adjusted hazard ratio for progression or death at 0.37.

The study's outcomes strongly support the combined use of doxorubicin and trabectedin as a first-line treatment for advanced or metastatic leiomyosarcoma. According to the researchers, this combination offers hope for better management of this particularly challenging form of cancer.

The research received partial funding from PharmaMar, the company that manufactures trabectedin.