Abstract 1547P
Background
Trabectedin (Yondelis®) is a marine-derived drug with anticancer activity approved for the treatment of patients with advanced soft-tissue sarcomas (STS) previously treated with at least one line of therapy. In Italy, the use of trabectedin for STS patients has been monitored since 2013 through a registry run by the national drug regulator, i.e. the Italian Medicines Agency (AIFA).
Methods
Data on STS patients treated with trabectedin in Italy were prospectively collected from January, 2013 to December, 2019. They included: baseline patients characteristics (including histology), dose of trabectedin administered at each cycle, reasons for treatment discontinuation, region(s) of treatment and treating center. Time-to-off-treatment (TToT) were investigated using Kaplan-Meier’s estimator and were presented as median value (95% Confidence Intervals, CI). The impact of the different covariates on TToT was evaluated using an accelerated failure time (AFT) model with log-logistic distribution.
Results
In total, we analyzed data from 2,633 sarcoma patients and 14,950 individual cycles of trabectedin. The median number of cycles of trabectedin received per patient was 3 (2-7), with a positively skewed distribution. The most common initially administered dose of trabectedin was the standard, i.e. 1.5 mg/sqm (719/2633, 27.3%). Likewise, 32.8% of patients received at least one cycle of trabectedin with a lowered dose. Trabectedin treatment was associated to inter-regional mobility. Overall, the median TToT was 93 days (95% CI 89-100). Considering main histological sarcoma subtypes, the median TToT was 104 days (95% CI 96-112) for leiomyosarcoma, 161 days (95% CI 120-188) for well differentiated/dedifferentiated liposarcoma and 123 days (95% CI 100-158) for myxoid liposarcoma. In the final AFT model, the variables significantly associated to TToT were gender, ECOG PS, histological subtype, and being a reference center.
Conclusions
In Italy the use of trabectedin was associated to inter-regional mobility. There were considerable variations of dosage across cycles. Median duration of treatment was in the range of 3-6 months for all the main sarcoma histologies in which the drug is recommended.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.