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Neoadjuvant Imatinib in DFSP. a SARC study U Michigan coordinating center. Dermatofibrosarcoma protuberans. Incidence - 1500 cases per year Low-grade fibrohistiocytic tumor Treated with surgery Imatinib is active in DFSP, has been used in advanced cases.
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Neoadjuvant Imatinibin DFSP a SARC study U Michigan coordinating center
Dermatofibrosarcoma protuberans • Incidence - 1500 cases per year • Low-grade fibrohistiocytic tumor • Treated with surgery • Imatinib is active in DFSP, has been used in advanced cases
SARC study: pre-operative imatinib in newly diagnosed DFSP Objectives: • Determine effects of imatinib on phosphorylation of PDGFRB in DFSP • Correlate inhibition of PDGFRB with: • plasma and tissue levels of imatinib • Inhibition of downstream kinases • Inhibition of tumor proliferation – Ki-67/MIB-1 • Induction of apoptosis • Bank patient matched tissue for future study
DFSP: pre-operativetreatment plan • Biopsy to establish diagnosis, obtain pre-imatinib fresh tumor for molecular studies • Imatinib 400 mg bid for 10 to 14 days prior to planned surgical resection • Blood draw for imatinib plasma level within 24 hrs of surgery • Collect tumor for study at surgery • 15 evaluable patients (viable matched tumor tissue/subject taking imatinib)
DFSP: logistics • Pre-imatinib fresh/frozen tumor required • Imatinib-treated fresh/frozen tumor required • CBC at day 7-10 required (safety) • Blood sample for imatinib level at time of surgery required • Gleevec supplied by SARC • Paper case report forms • SARC pay for pre-treatment biopsy
Implementation timeline • Activated at UM October 2005 • Undergoing review at MD Anderson, University of Washington, Memorial, Dana-Farber