TY - JOUR
T1 - Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib
T2 - a randomised controlled trial
AU - Demetri, George D.
AU - van Oosterom, Allan T.
AU - Garrett, Christopher R.
AU - Blackstein, Martin E.
AU - Shah, Manisha H.
AU - Verweij, Jaap
AU - McArthur, Grant
AU - Judson, Ian R.
AU - Heinrich, Michael C.
AU - Morgan, Jeffrey A.
AU - Desai, Jayesh
AU - Fletcher, Christopher D.
AU - George, Suzanne
AU - Bello, Carlo L.
AU - Huang, Xin
AU - Baum, Charles M.
AU - Casali, Paolo G.
PY - 2006/10/14
Y1 - 2006/10/14
N2 - Background: No effective therapeutic options for patients with unresectable imatinib-resistant gastrointestinal stromal tumour are available. We did a randomised, double-blind, placebo-controlled, multicentre, international trial to assess tolerability and anticancer efficacy of sunitinib, a multitargeted tyrosine kinase inhibitor, in patients with advanced gastrointestinal stromal tumour who were resistant to or intolerant of previous treatment with imatinib. 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 off treatment. The primary endpoint was time to tumour progression. Intention-to-treat, modified 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 significantly 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
AB - Background: No effective therapeutic options for patients with unresectable imatinib-resistant gastrointestinal stromal tumour are available. We did a randomised, double-blind, placebo-controlled, multicentre, international trial to assess tolerability and anticancer efficacy of sunitinib, a multitargeted tyrosine kinase inhibitor, in patients with advanced gastrointestinal stromal tumour who were resistant to or intolerant of previous treatment with imatinib. 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 off treatment. The primary endpoint was time to tumour progression. Intention-to-treat, modified 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 significantly 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
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U2 - 10.1016/S0140-6736(06)69446-4
DO - 10.1016/S0140-6736(06)69446-4
M3 - Article
C2 - 17046465
AN - SCOPUS:33749505836
VL - 368
SP - 1329
EP - 1338
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9544
ER -