This study was a double-blind, placebo-controlled, international, multicentre, 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 6-week cycle consisting of a 50 mg capsule once daily for 4 weeks, followed by a 2-week break.
Results from the first planned interim analysis of this trial, disclosed at ECCO 13, demonstrate a 4-fold increase in the average time to progression (TTP) with sunitinib treatment, as compared to placebo. The estimated median TTP was 6.3 months with sunitinib, versus 1.5 months for placebo. Overall survival (OS) has also been estimated to be significantly greater with sunitinib therapy, although the average OS survival point has not yet been reached in either the sunitinib or placebo treatment arm.
Overall, treatment with sunitinib was well tolerated with fatigue, diarrhoea, nausea, sore mouth and skin discolouration proving to be the most common non-haematological side effects. Adverse events were generally mild to moderate and no severe effects (grade 4) were noted during the course of the study.
Dr George Demetri from the Dana-Farber Cancer Institute and Harvard Medical School, USA summarised: "These results from our global collaborative team provide important confirmatory evidence that documents the significant efficacy and acceptable tolerability of sunitinib (SU11248) in patients with metastatic GIST whose disease was resistant to imatinib, or th
Contact: Kirsten Mason
Federation of European Cancer Societies