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Updated: May 31, 2026
A Mouse Model of Incompletely Resected Soft Tissue Sarcoma for Testing (Neo)adjuvant Therapies
Published on: July 28, 2020
Phase 2 Southwest Oncology Group-directed intergroup trial (S0505) of sorafenib in advanced soft tissue sarcomas
Margaret von Mehren1, Cathryn Rankin, John R Goldblum
1Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, USA. margaret.vonMehren@fccc.edu
Background:
Patients with advanced soft tissue sarcomas (STS) have limited therapeutic options. Sorafenib (BAY 43-9006) is a multitargeted tyrosine kinase inhibitor of raf, vascular endothelial growth factor receptors 1 (VEGFR1) through 3, platelet-derived growth factor B, fms-like tyrosine kinase 3, and c-kit, and some of these may be relevant in STS.
Methods:
The authors tested sorafenib at a dose of 400 mg twice daily in patients with advanced vascular sarcoma (VS), high-grade liposarcomas, and leiomyosarcomas who had received 0 or 1 previous regimens for advanced disease.
Results:
Fifty-one patients were accrued to the study, and 37 were evaluable for toxicity and response. There were no unexpected side effects and no confirmed responses. The median progression-free survival was 3 months, and the median overall survival was 17 months. Six of 8 patients in the VS cohort had prolonged clinical benefit (stable disease or better), resulting in a median progression-free survival of 5 months compared with 2 to 3 months for the patients who had liposarcoma and leiomyosarcomas.
Conclusions:
Sorafenib at the dose and schedule studied did not result in any responses in the VS, liposarcoma, or leiomyosarcoma cohort according to Response Evaluation Criteria in Solid Tumors.
Insights
Sorafenib did not show response in advanced soft tissue sarcomas (STS). However, vascular sarcoma patients experienced prolonged progression-free survival, suggesting potential benefit in this subtype.
Area of Science:
- Oncology
- Medical Oncology
- Sarcoma Research
Background:
- Advanced soft tissue sarcomas (STS) present limited treatment avenues.
- Sorafenib, a multi-kinase inhibitor, targets pathways potentially relevant to STS.
Purpose of the Study:
- To evaluate the efficacy and safety of sorafenib in patients with advanced vascular sarcoma (VS), liposarcomas, and leiomyosarcomas.
Main Methods:
- A phase II study administered sorafenib (400 mg twice daily) to patients with advanced STS who had received 0-1 prior regimens.
- Patient cohorts included VS, high-grade liposarcomas, and leiomyosarcomas.
Main Results:
- No confirmed responses were observed across all cohorts according to RECIST criteria.
- Median progression-free survival was 3 months, and median overall survival was 17 months.
- Vascular sarcoma patients showed a median progression-free survival of 5 months, indicating prolonged clinical benefit in 6 of 8 patients.
Conclusions:
- Sorafenib, at the tested dose and schedule, did not induce responses in advanced VS, liposarcoma, or leiomyosarcoma.
- A subset of vascular sarcoma patients experienced prolonged disease stabilization, warranting further investigation.
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