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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.
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.
Sunitinib is the standard second-line kinase inhibitor for GIST, with particular activity against KIT exon 9 and exon 13/14 secondary mutations.
Shares Imatinib-resistant GIST, Sunitinib, Imatinib, The Lancet.
Shares Imatinib-resistant GIST, Sunitinib, Imatinib.
Shares Imatinib-resistant GIST, Sunitinib.
Shares Sunitinib, The Lancet.
Shares Sunitinib, The Lancet.
Shares Imatinib-resistant GIST, Sunitinib, Imatinib.
Shares Imatinib-resistant GIST, Imatinib.