Jason Hoffman, PharmD, RPh March 23, 2015 According to a recent study published online in the journal The Lancet Oncology, researchers have found that doxorubicin plus trabectedin have activity as first-line treatment for uterine leiomyosarcoma and soft-tissue leiomyosarcoma.
Researchers sought to investigate the effect of first-line doxorubicin and trabectedin on disease control and survival in patients with metastatic leiomyosarcoma of uterine or soft-tissue origin in a single-group, multicenter, phase 2 study. Researchers enrolled and treated 109 patients with doxorubicin 60mg/m2 intravenously and trabectedin 1.1mg/m2 intravenously on day 1, and pegfilgrastim 6mg subcutaneously on day 2, every 3 weeks for up to six cycles.
Ultimately, 68% of those with uterine leiomyosarcoma and 74% of those with soft-tissue leiomyosarcoma received all six cycles. Results showed that 59.6% of patients with uterine disease achieved a partial response, 27.7% had stable disease, and 87.2% achieved disease control. Of those with soft-tissue disease, 3.3% achieved a complete response, 36.1% achieved a partial response, 52.5% had stable disease, and 91.8% achieved disease control.
In regard to safety, the most common severe adverse events were neutropenia, alanine aminotransferase elevation, thrombocytopenia, anemia, febrile neutropenia, and fatigue. The authors conclude that this drug combination should be developed further in a phase 3 study compared to the standard of care in this patient population.