What makes real world outcomes in soft tissue sarcomas? A mono-institutional trabectedin experience

Introduction > Trabectedin proved its efficacy in relapsed advanced soft tissue sarcomas (STS) in 3 multicenter phase II studies with selected patients. The aim of the present study is to investigate trabectedin efficacy and tolerance in a cohort of "real-life'' unselected patients with sarcoma. Methods > A single-center analysis was carried out on all consecutive patients with histologically proven unresectable advanced or metastatic STS, who received at least one cycle of trabectedin. Data on efficacy and tolerance were retrospectively reported. Results > From 2004 to 2014, data of 59 patients were reviewed. Median age was 62 years (from 23 to 87). A total of 317 cycles of trabectedin were administered. Twenty-five patients (42%) suffered grade 3-4 hematological toxicity, mainly with neutropenia (22 patients, 37%). Disease control rate was 24%, mainly with stable disease, and 45 patients (76%) experienced disease progression. Median overall survival was 6.6 months (95% CI [4.9-12.6]). Conclusion > Trabectedin might be an option for patients without any other validated alternative, but phase III study evaluating trabectedin + best supportive care (BSC) versus BSC is necessary.