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Bending the Curve Trial by Trial
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Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial

Phase 3N = 946NCT00685828

Population
Patients with metastatic (advanced) GIST
Design
Randomised trial of imatinib 400 mg once or twice daily in metastatic GIST. Patients on the once-daily regimen who progressed were offered crossover. Analysis by intention to treat.
Primary endpoint
PFS
Arms
  • Imatinib 400 mg once daily (control, n = 473): Imatinib 400 mg once daily
  • Imatinib 400 mg twice daily (experimental, n = 473): Imatinib 400 mg twice daily (800 mg/day)
People
Verweij J, EORTC
PFSHR 0.82 (95% CI 0.69–0.98)
Show the numbers
Results reported for Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial
EndpointAnalysisImatinib 400 mg twice dailyImatinib 400 mg once dailyEffect
PFSprimaryVerweij 2004——HR 0.82 (95% CI 0.69–0.98)P=0.026The abstract gives no median PFS. At a median follow-up of 760 days (IQR 644-859), 263 of 473 patients (56%) on once-daily imatinib had progressed vs 235 of 473 (50%) on twice-daily dosing; the hazard ratio is described as estimated.
Results reported for Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial
EndpointAnalysisImatinib 400 mg twice dailyImatinib 400 mg once dailyEffect
PFSprimaryVerweij 2004——HR 0.82 (95% CI 0.69–0.98)P=0.026The abstract gives no median PFS. At a median follow-up of 760 days (IQR 644-859), 263 of 473 patients (56%) on once-daily imatinib had progressed vs 235 of 473 (50%) on twice-daily dosing; the hazard ratio is described as estimated.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.820.69–0.98
Primary publication: Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, et al. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004;364(9440):1127-34. PubMedDOI

Appears in

Sources

  1. Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, et al. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004;364(9440):1127-34.

    PubMedDOI