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Clinical Trial
. 2012 Feb 1;118(3):770-6.
doi: 10.1002/cncr.26334. Epub 2011 Jul 12.

Phase 2 Southwest Oncology Group-directed intergroup trial (S0505) of sorafenib in advanced soft tissue sarcomas

Margaret von Mehren  1 , Cathryn Rankin, John R Goldblum, George D Demetri, Vivien Bramwell, Christopher W Ryan, Ernest Borden
Affiliations
Clinical Trial

Phase 2 Southwest Oncology Group-directed intergroup trial (S0505) of sorafenib in advanced soft tissue sarcomas

Margaret von Mehren et al. Cancer. .

Abstract

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.

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Figures

Figure 1
Figure 1
A: Kaplan Meyer Plot of Progression Free Survival B: Kaplan Meyer Plot of Overall Survival
Figure 1
Figure 1
A: Kaplan Meyer Plot of Progression Free Survival B: Kaplan Meyer Plot of Overall Survival
Figure 2
Figure 2
Kaplan Meyer Plot of Progression Free Survival by Cohort
Figure 3
Figure 3
Images of patient with solitary fibrous tumor at baseline in May 2006, upper panel, and 22 months later in March 2008 demonstrating changes in tumor density with prolonged stable disease. Baseline Hounsfield units in the liver and ileum lesions were 112.8 and 174.4 respectively. On the follow-up scan they have decreased to 51.1 and 45.8 respectively.
See this image and copyright information in PMC

References

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