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Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial
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Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial
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Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial
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Journal Article
Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial
2004
Overview
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.
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.
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).
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.
Publisher
Elsevier Ltd,Elsevier Limited
Subject
/ Antineoplastic Agents - administration & dosage
/ Antineoplastic Agents - adverse effects
/ Dose-Response Relationship, Drug
/ Drug Administration Schedule
/ Female
/ Gastrointestinal Neoplasms - drug therapy
/ Gastrointestinal Neoplasms - mortality
/ Gastrointestinal Neoplasms - pathology
/ Humans
/ Male
/ Neoplasm Recurrence, Local - drug therapy
/ Piperazines - administration & dosage
/ Piperazines - adverse effects
/ Protein-Tyrosine Kinases - antagonists & inhibitors
/ Pyrimidines - administration & dosage
/ Pyrimidines - adverse effects
/ Survival
/ Tumors
