Disease Information for Sunetinib (Sutent) Administration/Toxicity

Oral chemotherapy drug; Multikinase inhibitor like Nexavar; used for GIST or gastriointestinal stromal tumors and renal advanced cell carcinoma; Tyrosinase and multikinase receptor inhibitor on cancer cell; best on gleevec failures; protocol 4 weeks on then two weeks off; tumor growth angiogenesis and metastatic progression block by inhibitor of receptor for platelet-derived growth factor

receptor or PDGFR, vascular endothelial growth factor receptor VEGFR,stem cell factor receptor KIT, fms-like tyrosine kinase 3 or FLT3, colony stim factor rcptr type 1 or CSF-1R, and glial cell line neurotropic factor receptor or RET; preparation oral only 12-5 mgm, 25 mgm, and 50 mgm capsules; from PDR Released 2006.cardiomyopathy, severe hypertension, adrenal toxicity/insufficiency, gi bleed reported;-[company release 2005 FDA trials]--------------Pfizer Inc"s investigational new drug SUTENT/SU11248 (sunitinib malate) more than doubled survival and significantly reduced tumor growth and spread in a Phase III study in patients with Gleevec-resistant gastrointestinal stromal tumors (GIST); Encouraging Phase II results also were observed in other tumor types, including metastatic renal cell carcinoma (mRCC), metastatic breast cancer and neuroendocrine tumors,

"These data support SUTENT"s activity against hard-to-treat tumors, particularly GIST and mRCC, both potentially life-threatening and with few, if any, other options," SUTENT is a highly selective, multi-targeted tyrosine kinase inhibitor that starves tumors of blood and nutrients needed for growth and simultaneously kills cancer cells that make up tumors;

GIST Studies: Results from a double-blind Phase III study of more than 300 GIST patients resistant to or intolerant of the standard treatment Gleevec(R) (imatinib mesylate) showed SUTENT significantly prolonged the time to tumor progression (6-3 months on SUTENT vs 1-5 months for controls) and reduced the risk of death by approximately 50 percent compared to placebo; In addition, long-term follow-up data from the Phase I/II GIST study that served as the basis for the larger Phase III trial demonstrated that SUTENT extended overall survival to nearly 20 months in patients whose cancer had progressed despite treatment with other standard therapies; In addition, the median time to tumor progression in this study was 7-8 months for all patients, with some specific subtypes of patients benefiting even more dramatically than would be expected with Gleevec;

(Edit)