Abstract
10535 Background: Metastatic soft tissue sarcoma represents a diverse collection of disease types. Sunitinib malate is a multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and stem cell factor receptor, with proven efficacy in imatinib mesylate-refractory or intolerant gastrointestinal stromal tumors (GIST). This study was designed to evaluate the efficacy and tolerability of sunitinib malate in four non-GIST sarcoma subytpes (liposarcoma, malignant fibrous histiocytoma, fibrosarcoma and leiomyosarcoma). Methods: Eligibility criteria included tissue documented metastatic soft tissue sarcomas, measurable disease (by RECIST criteria), and a maximum of three prior lines of therapy for metastatic disease. Treatment was with sunitinib malate 50 mg orally daily in 6 week cycles (4 weeks on/ 2 weeks off). Results: Thirty-six subjects have been accrued to date, 12 patients with leiomyosarcoma, 12 with liposarcoma, 11 with malignant fibrous histiocytoma (MFH) and one patient with fibrosarcoma. The median age was 64, range 42–86, male/female 18/18, ECOG performance status 0/1/2 24/11/1. The median number of cycles administered has been 3 (range 1 to 7). Tolerance of therapy has been acceptable with the only three serious drug-related adverse events being congestive heart failure and pulmonary emboli. One confirmed partial response was seen. 29 (80.6%) subjects have observed stable disease for at least 12 weeks. Conclusions: The data from the study to date demonstrate acceptable tolerability of sunitinib in metastatic soft tissue sarcomas of different histologies. A high percent of subjects with stable disease was observed. These finding support further evaluation of sunitinib malate in soft tissue sarcomas. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pfizer Oncology
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