Background Soft tissue sarcomas (STSs) are rare tumours arising from connective tissues characterised by high morphologic and biologic heterogeneity, as well as by limited responsiveness to cytotoxic chemotherapeutic agents. Trabectedin was approved in 2007 for patients with advanced STS after failure of anthracyclines and ifosfamide, or for patients unsuited to receive these agents.

Purpose To obtain basic epidemiological information on patients with soft tissue sarcomas, standard treatment procedures and results of trabectedin treatment in clinical practise.

Materials and Methods This retrospective study analysed 31 STS patients treated with trabectedin between January 2009 and September 2012. A retrospective cohort study of all patients with a diagnosis of STS treated with trabectedin 1.5 mg/m², D1, 24 hours’ continuous IV infusion, every 3 weeks. Toxicity was evaluated using Common Terminology Criteria for Adverse Events (CTCAE).

Progression-free survival curves (PFS) and Overall Survival (a 95% confidence interval was used) were estimated by using the Kaplan-Meier method.

Results Median age at the initiation of trabectedin therapy was 52 years (18–79 years).

Leiomyosarcoma was the most frequent tumour (25.8%) and liposarcoma occurred in 16.2% of the patients.

Median number of cycles administered was 6.7 (2–16 cycles).

Thrombocytopenia, leukopenia (16.1% of patients), asthenia (12.9%) and elevation of liver transaminases (9.7% of patients) were the most frequent adverse effects.

Nine patients achieved a partial remission (PR) and in 3 the disease stabilised (SD).

Median overall survival (95% CI) was 6.0 months (0.8; 36.1), median progression-free survival (PFS) (95% CI) was 11.48 months.

PFS for all patients was 90.3% at three months and 79.0% at six months.

Conclusions Our results indicate that trabectedin shows promise as an effective and tolerable new drug for the treatment of patients with STS.

No conflict of interest.