Background Imatinib is approved worldwide for use in gastrointestinal stromal tumours (GIST). We aimed to assess dose dependency of response and progression-free survival with imatinib for metastatic GIST. Methods 946 patients were randomly allocated imatinib 400 mg either once or twice a day. Those assigned the once a day regimen who had progression were offered the option of crossover. The primary endpoint was progression-free survival. Analysis was by intention to treat. Findings At median follow-up of 760 days (IQR 644-859), 263 (56%) of 473 patients allocated imatinib once a day had progressed compared with 235 (50%) of 473 who were assigned treatment twice a day (estimated hazard ratio 0·82 [95% CI 0·69-0·98]; p=0·026). Side-effects arose in 465/470 (99%) patients allocated the once daily regimen compared with 468/472 (99%) assigned treatment twice a day. By comparison with the group treated once a day, more dose reductions (77 [16%] vs 282 [60%]) and treatment interruptions (189 [40%] vs 302 [64%]) were recorded in patients allocated the twice daily regimen, but treatment in both arms was fairly well tolerated. 52 (5%) patients achieved a complete response, 442 (47%) a partial response, and 300 (32%) stable disease, with no difference between groups. Median time to best response was 107 days (IQR 58-172). Interpretation If response induction is the only aim of treatment, a daily dose of 400 mg of imatinib is sufficient; however, a dose of 400 mg twice a day achieves significantly longer progression-free survival.
Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: Randomised trial / J. Verweij, P.G. Casali, J. Zalcberg, A. Lecesne, P. Reichardt, J. Blay, R. Issels, A. Van Oosterom, P.C.W. Hogendoorn, M. Van Glabbeke, R. Bertulli, I. Judson. - In: THE LANCET. - ISSN 0140-6736. - 364:9440(2004), pp. 1127-1134.
|Titolo:||Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: Randomised trial|
CASALI, PAOLO GIOVANNI (Secondo)
|Parole Chiave:||diagnosis; mesylate; efficay; safety|
|Settore Scientifico Disciplinare:||Settore MED/06 - Oncologia Medica|
|Data di pubblicazione:||2004|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/S0140-6736(04)17098-0|
|Appare nelle tipologie:||01 - Articolo su periodico|