The New England Journal of MedicineDoxorubicin–Trabectedin with Trabectedin Maintenance in Leiomyosarcoma

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This study presents significant findings on the efficacy of combination therapy with doxorubicin and trabectedin, followed by trabectedin maintenance, compared to doxorubicin alone in patients with advanced leiomyosarcoma. The research offers important insights into potential treatment strategies for this challenging malignancy.

Study Design:

• Phase 3 trial involving 150 patients with metastatic or unresectable leiomyosarcoma
• Patients randomized to receive either single-agent doxorubicin (six cycles) or doxorubicin plus trabectedin (six cycles) with trabectedin maintenance
• Median follow-up of 55 months (interquartile range, 49 to 63)
• Primary endpoint: progression-free survival; Secondary endpoint: overall survival
• Analyses adjusted for tumor origin site and disease stage

Key Findings:

• Median overall survival: 33 months in doxorubicin-trabectedin group vs. 24 months in doxorubicin group (adjusted HR for death: 0.65; 95% CI, 0.44 to 0.95)
• Median progression-free survival: 12 months in doxorubicin-trabectedin group vs. 6 months in doxorubicin group (adjusted HR: 0.37; 95% CI, 0.26 to 0.53)
• Higher incidence of adverse events and dose reductions in the combination therapy group
• Surgery to resect residual disease was allowed after six cycles of therapy in both groups

HCN Medical Memo
Although the combination of doxorubicin and trabectedin followed by trabectedin maintenance shows improved overall and progression-free survival in advanced leiomyosarcoma patients, the increased incidence of adverse events and dose reductions warrants careful consideration.

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