Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial
George D Demetri, Allan T van Oosterom, Christopher R Garrett, Martin E Blackstein, Manisha H Shah, Jaap Verweij, Grant McArthur, Ian R Judson, Michael C Heinrich, Jeffrey A Morgan, Jayesh Desai, Christopher D Fletcherhttp://academic.research.microsoft.com/io.ashx?type=5&id=29217923&selfId1=0&selfId2=0&maxNumber=12&query=
Methods Blinded sunitinib or placebo was given orally once daily at a 50-mg starting dose in 6-week cycles with 4 weeks on and 2 weeks o! treatment. The primary endpoint was time to tumour progression. Intention-to-treat, modifi ed intention-to-treat, and per-protocol analyses were done. This study is registered at ClinicalTrials.gov, number NCT00075218. Findings 312 patients were randomised in a 2:1 ratio to receive sunitinib (n=207) or placebo (n=105); the trial was unblinded early when a planned interim analysis showed signifi cantly longer time to tumour progression with sunitinib. Median time to tumour progression was 27·3 weeks (95% CI 16·0-32·1) in patients receiving sunitinib and 6·4 weeks (4·4-10·0) in those on placebo (hazard ratio 0·33; p<0·0001). Therapy was reasonably well tolerated; the most common treatment-related adverse events were fatigue, diarrhoea, skin discolouration, and nausea.
, vol. 368, no. 9544, pp. 1329-1338, 2006