Soft-Tissue Sarcoma Treated Effectively With a Long-Term Therapy
Long-term therapy with a recently approved drug is well tolerated in patients with soft-tissue sarcoma, according to results of a study presented at the Connective Tissue Oncology Society Annual Meeting (November 8-11, 2017; Maui, HI).
Patients with soft-tissue sarcoma often have limited long-term systemic therapy options due to the risk of cumulative toxicity. A recent phase II study evaluated trabectedin—an antitumor chemotherapy agent—for patients with locally advanced or metastatic soft-tissue sarcoma who underwent prior conventional therapies. Patients enrolled in this study were involved in an expanded access program.
Elizabeth J Davis, MD, Vanderbilt University School of Medicine, and colleagues conducted a follow-up retrospective study on the safety and efficacy of those patients who received long-term trabectedin therapy (at least 6 months). The analysis included 1803 patients, all of whom received trabectedin, administered intravenously at 1.5 mg/m2 every 3 weeks. Researchers compared safety and efficacy data of patients who received treatment for 6 to 12 months with those who received treatment for more than 12 months.
Dr Davis and colleagues noted that 21.6% (n = 401) of patients remained on treatment for at least 6 months, 14.5% (n = 268) for 6 to 12 months, and 7.2% (n = 133) for more than 12 months.
Results of the analysis showed that median overall survival (OS) was 11.9 months in the entire cohort, 18.1 months for those in the 6 to 12-month cohort, and 47.0 months in the more than 12-month cohort. The clinical benefit rates were 41.2%, 47.4%, and 38.3%, respectively.
Incidence of treatment-related adverse events were similar between those treated for 6 to 12 months and those treated longer than 12 months (84% vs 89.5%, respectively). However, researchers noted that patients in the latter cohort were more likely to require treatment cycle delays and to experience serious grade 3 or 4 adverse events. The majority of patients in both cohorts discontinued treatment due to disease progression.
“Improved median OS may be achieved in patients who experience prolonged disease stabilization; however, adjustments in the trabectedin dose or schedule are frequently required,” authors of the study concluded.—Zachary Bessette