Trabectedin Plus Radiotherapy for Advanced Soft-Tissue Sarcoma: Experience in Forty Patients Treated at a Sarcoma Reference Center.

Simple Summary: Active therapeutic options in advanced sarcomas, able to induce durable objective responses, are scarce beyond first line. New strategies for disease and symptomatic control are thus needed. Our aim was to analyze the activity of the combination of trabectedin and palliative radiotherapy in the real-life setting, in patients with pretreated metastatic sarcoma. Our findings on 40 pretreated metastatic soft-tissue sarcoma patients, in terms of objective responses (overall response rate by RECIST of 32.5%) and outcome (median progression-free survival of 7.5 months and median overall survival of 23.5 months), confirm the activity of this regimen, which is a valuable option to consider, especially in patients in which a dimensional response could help for symptomatic control. Symptomatic control and tumoral shrinkage is an unmet need in advanced soft-tissue sarcoma (STS) patients beyond first-line. The combination of trabectedin and radiotherapy showed activity in a recently reported clinical trial in this setting. This retrospective series aims to analyze our experience with the same regimen in the real-life setting. We retrospectively reviewed advanced sarcoma patients treated with trabectedin concomitantly with radiotherapy with palliative intent. Growth-modulation index (GMI) was calculated as a surrogate of efficacy. Forty metastatic patients were analyzed. According to RECIST, there was one (2.5%) complete response, 12 (30%) partial responses, 18 (45%) disease stabilizations, and nine (22.5%) progressions. After a median follow-up of 15 months (range 2–38), median progression-free survival (PFS) and overall survival (OS) were 7.5 months (95% CI 2.8–12.2) and 23.5 months (95% CI 1.1–45.8), respectively. Median GMI was 1.42 (range 0.19–23.76), and in 16 (53%) patients, it was >1.33. In patients with GMI >1.33, median OS was significantly longer than in those with GMI 0–1.33 (median OS 52.1 months (95% CI not reached) vs. 8.9 months (95% CI 6.3–11.6), p = 0.028). The combination of trabectedin plus radiotherapy is an active therapeutic option in patients with advanced STS, especially when tumor shrinkage for symptomatic relief is needed. [ABSTRACT FROM AUTHOR]