Table 2.
Clinical trials of imatinib in metastatic GIST
| Study | Study Type |
Dosages studied | Number of patients |
Results |
|---|---|---|---|---|
| van Oosterom, A.T., et al |
Phase I | 400mg q.d.,300mg b.i.d., 400mg b.i.d., 500mg b.i.d |
40 | 54% PR 37% SD |
| Demetri, G.D., et al. |
Phase II |
400mg q.d vs. 600mg q.d | 147 | No statistically significant differences in toxicity or response between the two doses. |
| Response rate in the 400mg q.d arm 49.3% PR, 31.5%SD, and 16.4 % PD. |
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| Response rate in the 600mg q.d arm 58.1%PR, 24.3%SD, and 10.8% PD. |
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| Verweij, J., et al. | Phase II | 400mg b.i.d | 27 | 4% CR,67% PR, 19% SD,11% PD 73% free from disease at 1 year |
| Verweij, J., et al. | Phase III | 400mg q.d vs. 400mg b.i.d | 946 | Response rate in the 400mg q.d arm 4% CR, 45% PR, 32% SD, 13% PD. |
| Response rate in the 400mg b.i.d arm 6% CR, 48% PR, 32% SD, 9% PD. |
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| After a median follow-up of 760 days, 263 (56%) of 473 patients in the once a day arm had progressed compared with 235 (50%) of 473 in the twice a day arm hazard ratio 0·82 [95% CI 0·69–0·98]; p=0·026. |
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| OS was 85% at 1 year and 69% at 2 years in patients treated once a day, and 86% at 1 year and 74% at 2 years in those treated twice a day. |
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| Increased dose reductions (77 [16%] vs 282 [60%]) and interruptions (189 [40%] vs 302 [64%]) in the twice a day arm. |
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| Blanke, C.D., et al | Phase III | 400mg q.d vs. 400mg b.i.d | 694 | Response rate in the 400mg q.d arm 5% CR, 40% PR, 25% SD, 12% PD. |
| Response rate in the 400mg b.i.d arm 3% CR, 42% PR, 22% SD, 10% PD |
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| Median PFS was 18 and 20 months in the once daily and twice daily arms respectively. |
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| Median OS was 55 and 51 months, in the once daily and twice daily arms respectively. |
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| No statistically significant differences in objective response rates, PFS or OS. |
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