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Updated: May 16, 2026
A Mouse Model of Incompletely Resected Soft Tissue Sarcoma for Testing (Neo)adjuvant Therapies
Published on: July 28, 2020
Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy
A Santoro1, A Comandone, U Basso
1Department of Oncology-Haematology, Humanitas Cancer Center, IRCCS, Milan, Italy. armando.santoro@cancercenter.humanitas.it
Introduction:
We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS).
Patients And Methods:
An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A).
Results:
Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5%) achieved partial response and 25 (32.9%) stable disease; 6-month PFS rates were all histologies, 34.5%; L, 38.4%; and A, 56.3%. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5% in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P = 0.033). Treatment was well tolerated.
Conclusions:
Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.
Insights
Sorafenib showed promise in advanced soft tissue sarcomas, particularly leiomyosarcoma. The drug was well-tolerated, suggesting potential for future histology-driven trials in sarcoma treatment.
Area of Science:
- Oncology
- Medical Research
- Pharmacology
Background:
- Investigated the efficacy and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor.
- Focused on patients with advanced soft tissue sarcomas (STS) previously treated with anthracycline-based chemotherapy.
Purpose of the Study:
- To evaluate the activity and safety of sorafenib in advanced STS.
- To determine the progression-free survival (PFS) rate at 6 months as the primary endpoint.
Main Methods:
- An open-label, nonrandomized, multicenter phase II study.
- 101 patients with advanced STS received sorafenib 400 mg twice daily.
- Clinical outcomes and toxicity were assessed, stratified by histology, including leiomyosarcoma (L) and angiovascular sarcomas (A).
Main Results:
- In per-protocol analysis, 6-month PFS rates were 34.5% (all histologies), 38.4% (L), and 56.3% (A).
- Intention-to-treat analysis showed 6-month PFS rates of 27.1% (all), 35% (L), and 35.5% (A).
- Leiomyosarcoma demonstrated a statistically significant better PFS compared to other histologies (P = 0.033); treatment was well tolerated.
Conclusions:
- Sorafenib is a potential treatment option for patients with leiomyosarcoma.
- Further histology-driven clinical trials are warranted to confirm these findings.
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