The efficacy and safety of trabectedin in patients with advanced liposarcomas and leiomyosarcomas (L-sarcomas)

Abstract

Introduction. Trabectedin is a novel drug approved for the treatment of patients with advanced soft tissue sarcoma. It shows activity especially in the palliative treatment of liposarcomas (LPS) and leiomyosarcoma (LMS). The aim of this work was to analyze the results of treatment with the use of trabectedin in one oncology center.

Materials and methods. From April 2008 to October 2013, 50 patients (23 women, 27 men) with metastatic/locally advances L-sarcomas have been treated with trabectedin. Pathological diagnosis were as follows: 20 leiomyosarcoma (LMS), 30 liposarcoma (LPS) — including 13 myxoid LPS (MPLS). Median age at treatment start was 51 years. Nearly all patients had previous chemotherapy based on doxorubicin. 14 (28%) patients received trabectedin in second line of treatment, 23 (46%) in third line, 13 (26%) in > third line of treatment. Responses to treatment were evaluated every 3 months by computed tomography imaging according to RECIST 1.1 criteria.

Results. Median of received cycles of treatment is 5 (range 2–40); 18 patients (36%) received ≥ 10 cycles. 4 patients (8%) had partial response according to RECIST, 23 (46%) had stable disease, 23 (46%) had progressive disease. After 6 months 47% of the patients were free from disease progression, more in the LPS group — 66% than in LMS group — 27% p = 0,023. Progression free survival (PFS) was significantly longer in patients receiving trabectedin in 2. or 3. (median 7 months) line than > third line of treatment (median 2 months) p = 0,038. Median overall survival (OS) is 13 months with 37 patients died at the time of analysis. Neither hemoglobin level nor LDH level at the start of treatment had impact on the results. 34 patients after progression received next line chemotherapy. Histology had impact on OS (p = 0.008), almost 70% of patients with MLPS lived longer than a year. Toxicity was moderate. 30 (60%) patients had some kind of treatment toxicity, in majority grade 1 or 2. Three patients required dose reductions.

Conclusion. Our analysis confirms efficacy and safety of trabectedin in patients with advanced L-sarcomas. Use of the drug give possibility for long lasting control of the disease with good tolerance of the treatment. The longest overall survival could be observed in patient with the diagnosis of myxoid liposarcoma.