Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Retrospective, Multicenter Study of...

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Advanced soft tissue sarcoma (STS) often requires multi-line treatment strategies.
• Trabectedin is an established chemotherapeutic agent for STS.
• Real-world data is crucial for understanding treatment patterns and outcomes in routine clinical practice.

Purpose of the Study:

• To evaluate the real-life utilization of trabectedin in Italian patients with advanced STS.
• To assess the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) associated with trabectedin treatment.
• To identify factors influencing trabectedin efficacy and safety in a diverse STS patient population.

Main Methods:

• Retrospective analysis of 512 patients with advanced STS from 20 Italian centers.
• Patients received trabectedin every three weeks after at least one anthracycline-based treatment.
• Data collection included demographics, histology, treatment lines, ORR, PFS, OS, and adverse events.

Main Results:

• Trabectedin was predominantly used as a second-line treatment (~60%) in patients with good performance status.
• Higher ORR (16.6% vs. 9.0%) and improved PFS/OS were observed in patients with leiomyosarcoma/liposarcoma (L-sarcoma).
• Median PFS was 5.1 months and median OS was 21.6 months. Common grade 3/4 toxicities included bone marrow suppression (61.4%) and transaminase increases (21.9%).

Conclusions:

• Trabectedin demonstrates significant activity in real-world settings for advanced STS, particularly for L-sarcoma.
• Early-line treatment and objective response correlate with better survival outcomes.
• Trabectedin is a valuable therapeutic option for advanced STS, with a manageable safety profile, especially in the second-line setting.