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- W2258464546 abstract "6026 Background: Sorafenib is a multi-tyrosine kinase inhibitor affecting Raf kinase, VEGFR, and PDGFR. We are conducting an open-label phase II study of sorafenib in patients with metastatic, iodine-refractory thyroid carcinoma to determine its efficacy and to identify biologic changes resulting from sorafenib therapy. Methods: Patients with metastatic, iodine-refractory, unresectable or locally-advanced thyroid cancer were administered sorafenib 400 mg orally BID. Responses were monitored by PET at four weeks and CT's every two to three months. The primary endpoints were response rate (RR) and time to progression (TTP) by RECIST criteria. BRAF mutation status is being determined by DNA sequencing. Pre-treatment and on-treatment tissue is being analyzed by immunohistochemistry and imaging analysis for markers of early biologic activity of sorafenib, including pERK and Ki-67, in a subset of patients in whom tissue is available. Results: To date, 36 patients have enrolled on study; median time on study is 19.5 weeks. Median age is 64 years (range 31 to 89), 18 pts (50%) are male. Histological subtypes include papillary: 22 pts (61%); follicular/Hurthle Cell: 10 pts (28%); medullary: 2 pts (5.5%), and poorly differentiated/anaplastic: 2 pts (5.5%). 34 patients are evaluable for response at this time. PR was achieved in 7 (21%) patients with a duration of response of 23.7+ to 82+ weeks. 20 (59%) had stable disease with a duration of response of 13.9+ to 87.9+ weeks. Among those who progressed, the median time to disease progression was 58.6 weeks. 21 patients remain on study. Sorafenib is well-tolerated; the most common treatment-related adverse events included fatigue, rash, diarrhea, palmer-plantar erythema (PPE), musculoskeletal pain, and weight loss. Grade 3 events included HTN: 3 pts (8%) and PPE: 3 pts (8%). One medullary thyroid cancer patient had grade 4 liver toxicity. 17 of 19 (95%) patients showed a marked response in thyroglobulin levels with a mean decrease of 70%. Correlative tissue studies, analysis of PET scans, and genotyping of all patients for BRAF mutation status are near completion. Conclusions: Sorafenib has significant anti-tumor activity in patients with advanced thyroid cancer with an overall clinical benefit rate (PR + SD) of 80%. No significant financial relationships to disclose." @default.
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- W2258464546 date "2008-05-20" @default.
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- W2258464546 title "A phase II study of sorafenib in metastatic thyroid carcinoma" @default.
- W2258464546 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.6026" @default.
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