Sunitinib in advanced gastrointestinal stromal tumour after failure of imatinib
Sunitinib more than quadrupled the time to progression compared with placebo in gastrointestinal stromal tumours that had become resistant to or intolerant of imatinib, establishing the standard second-line treatment.
Overview
Phase 3 placebo-controlled trial of 312 patients with advanced gastrointestinal stromal tumour after imatinib failure randomised 2:1 to sunitinib 50 mg daily (four weeks on, two off) or placebo, unblinded early after an interim analysis.
Median time to progression was 27.3 versus 6.4 weeks (hazard ratio 0.33) with a survival benefit at interim analysis (hazard ratio 0.49); fatigue, diarrhoea, skin discolouration and hand-foot syndrome were common.
- Median time to progression 27.3 vs 6.4 weeks; hazard ratio 0.33.
- Interim overall survival hazard ratio 0.49.
Sunitinib is the standard second-line kinase inhibitor for GIST, with particular activity against KIT exon 9 and exon 13/14 secondary mutations.
- Trial unblinded early; final survival analysis confounded by crossover.
- Less active against exon 17/18 secondary mutations.
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