Safety Profile of Trabectedin in Patients with Advanced Soft-Tissue Sarcoma (STS) Who Relapsed after Chemotherapy: Global Expanded Access Program Data

CTOS 2016


Study ET743-SAR-3002, an expanded access program, provided trabectedin to patients with incurable soft-tissue sarcoma (STS) following disease progression with standard therapy and represents one of the largest databases of pretreated STS patients. Prior efficacy and safety data from this study accrued over approximately 5 years through October 2010 and were published previously. Researchers presented an update of the cumulative data regarding serious adverse events (SAEs) collected through April 2016.

In this study, adults with advanced leiomyosarcoma, liposarcoma, and other STSs who relapsed after standard chemotherapy received trabectedin 1.5 mg/m2 every 3 weeks until documented disease progression or unacceptable toxicity. A total of 3253 patients were treated from 2005 until 2016.

The incidence of SAEs regardless of investigator-assigned causality was 42.5%. The most common SAEs were dyspnea (4.0%), vomiting (3.9%), nausea (3.8%), pneumonia (3.2%), dehydration (3.1%), pyrexia (3.0%), abdominal pain (2.6%), thrombocytopenia (2.6%), and anemia (2.4%). Select SAEs of interest included rhabdomyolysis (1.1%), neutropenic sepsis (0.03%), and cardiomyopathy (0.03%). Fatal SAEs occurred in 10% of advanced STS patients, the most common of which was “neoplasms” (3.5%).

The authors note that these extensive safety data are consistent with the known safety profile of trabectedin in advanced STS based on controlled clinical trials.

  • Jones R, et al. CTOS 2016. Abstract 2534346. P2 Poster 102.