Table 2.
Phase III clinical trials in advanced, unresectable GIST.
| Trial | Treatment (n) | Results | Conclusion | ||
|---|---|---|---|---|---|
| PR | SD | PD | |||
| EORTC 620057 | 400 mg qd (473) 400 mg bid (473) |
45% PR, 5% CR 48% PR, 6% CR |
32% 32% |
13% 9% |
2-yr PFS 56%, 32% Grade III–IV toxicity 2-yr PFS 50%, 50% Grade III–IV toxicity 400 mg daily achieves adequate response in advanced GIST |
| US-Canadian SWOG S003317 | 400 mg qd (345) 400 mg bid (349) |
40% PR, 5% CR 42% PR, 3% CR |
25% 22% |
12% 10% |
43% ≥ grade 3 toxicity 63% ≥ grade 3 toxicity 400mg initial dose, consider dose escalation with disease progression Median PFS 18m vs 20m, OS 55m vs. 51m (400 mg qd vs. 400 mg bid respectively; p=ns) 33% response after crossover to higher dose following progression |
PR – Partial response; SD – Stable disease; PD – Progressive disease, as defined by RECIST criteria.
PFS – Progression Free Survival (survival from date of randomization to date of progression or all cause death)
OS – Overall Survival (survival from date of randomization to date of all cause death)