Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors
Phase 2N = 147
- Population
- Patients with advanced unresectable or metastatic GIST (KIT expression is not stated in the abstracts)
- Design
- Open-label, randomised, multicentre trial of imatinib 400 mg or 600 mg daily in advanced (unresectable or metastatic) GIST. The abstract of the primary report does not name a control arm; the 400 mg arm is labelled control only as a schema convention. The long-term report (median follow-up 63 months) gives 73 and 74 patients in the two arms and calls the study a randomised phase II trial.
- Arms
- Imatinib 400 mg (control, n = 73): Imatinib 400 mg daily
- Imatinib 600 mg (experimental, n = 74): Imatinib 600 mg daily
- Both dose levels pooled (reporting group, not a randomised arm) (experimental, n = 147): Imatinib 400 mg or 600 mg daily (pooled)
- People
- Demetri GD
Show the numbers
| Endpoint | Analysis | Imatinib 600 mg / Both dose levels pooled (reporting group, not a randomised arm) | Imatinib 400 mg | Effect |
|---|---|---|---|---|
| ORRRandomly assigned patients (n=147); the abstract does not name the analysis populationPartial responses; no patient had a complete response. Response could not be evaluated in 7 patients (4.8 percent). | primaryDemetri 2002 | 53.7% | — | Pooled across the two dose groups; the abstract reports no significant differences in toxic effects or response between 400 mg and 600 mg. Stable disease: 41 patients (27.9 percent). Median duration of response not reached after a median follow-up of 24 weeks after the onset of response. |
| OSAll 147 enrolled patients | long term-updatemedian follow-up 63 monthsBlanke 2008 | median 57 months | — | Median survival for all patients. The abstract states that response rates, median progression-free survival and median overall survival were essentially identical on both arms, without giving arm-level values. |
| Endpoint | Analysis | Imatinib 600 mg / Both dose levels pooled (reporting group, not a randomised arm) | Imatinib 400 mg | Effect |
|---|---|---|---|---|
| ORRRandomly assigned patients (n=147); the abstract does not name the analysis populationPartial responses; no patient had a complete response. Response could not be evaluated in 7 patients (4.8 percent). | primaryDemetri 2002 | 53.7% | — | Pooled across the two dose groups; the abstract reports no significant differences in toxic effects or response between 400 mg and 600 mg. Stable disease: 41 patients (27.9 percent). Median duration of response not reached after a median follow-up of 24 weeks after the onset of response. |
| OSAll 147 enrolled patients | long term-updatemedian follow-up 63 monthsBlanke 2008 | median 57 months | — | Median survival for all patients. The abstract states that response rates, median progression-free survival and median overall survival were essentially identical on both arms, without giving arm-level values. |
- Both dose levels pooled (reporting group, not a randomised arm) (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Both dose levels pooled (reporting group, not a randomised arm) |
|---|---|
| 0 | 100.0% |
| 36 | 64.5% |
| 71 | 42.2% |
| 107 | 27.2% |
| 143 | 17.6% |
Appears in
Sources
Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002;347(7):472-80.
Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, et al. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008;26(4):620-5.