Updated results from a Phase III trial show that sunitinib (SU11248) prolongs both progression-free and overall survival in patients with progressive metastatic and/or unresectable GIST (gastrointestinal stromal tumors) whose disease has failed to respond to the standard therapy -- imatinib mesylate.
This study was a double-blind, placebo-controlled, international, multicenter, Phase III trial involving 312 patients with GIST whose cancer had progressed despite previous treatment with imatinib mesylate. Failure of imatinib mesylate therapy was either the result of resistance or intolerance. Sunitinib treatment was in a repeated six-week cycle consisting of a 50 mg capsule once daily for four weeks, followed by a two-week break.
Overall, treatment with sunitinib was well tolerated with fatigue, diarrhea, nausea, sore mouth and skin discoloration proving to be the most common non-hematological side effects. Adverse events were generally mild-to-moderate and no severe effects were noted during the course of the study