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Z9001

Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial

Phase 3NCT00041197

Population
Adults with complete gross resection of a primary GIST of at least 3 cm that was KIT-positive by immunohistochemistry
Design
Randomised, double-blind, placebo-controlled, multicentre phase III trial (stratified biased coin design). Placebo patients could cross over to imatinib on tumour recurrence. Accrual stopped early because the interim analysis crossed the efficacy boundary for recurrence-free survival. Sixty patients mis-randomised to placebo through a programming error were removed from the study (full text).
Primary endpoint
RFS
Arms
  • Imatinib 1 year (experimental, n = 359): Imatinib 400 mg daily for 1 year after resection
  • Placebo (control, n = 354): Placebo daily for 1 year after resection
People
Dematteo RP, American College of Surgeons Oncology Group (ACOSOG)
RFSHR 0.35 (95% CI 0.22–0.53)Δ 12-month RFS+15 pointsOSHR 0.66 (95% CI 0.22–2.03)
Show the numbers
Results reported for Z9001
EndpointAnalysisImatinib 1 yearPlaceboEffect
RFSRecurrence-free survival as named in the paperprimarymedian follow-up 19.7 monthsDematteo 200998% at 12 mo (96–100%)83% at 12 mo (78–88%)HR 0.35 (95% CI 0.22–0.53)P<0.0001One-sided p-value as published. Recurrence or death: 30 patients (8%) imatinib vs 70 (20%) placebo. Median follow-up range 0 to 56.4 months. Accrual stopped after a planned interim analysis crossed the efficacy boundary (interim HR 0.33, 95% CI 0.20 to 0.53 in the full text); these figures are from the paper's analysis of all data to 12 April 2007.
OSprimarymedian follow-up 19.7 monthsDematteo 2009——HR 0.66 (95% CI 0.22–2.03)P=0.4714Secondary endpoint; 13 deaths in 713 patients (5 imatinib, 8 placebo); the paper states there is no difference in overall survival at this time. The placebo arm is the hazard-ratio denominator. Read in the author manuscript (PMC2915459), not in the printed abstract.
Results reported for Z9001
EndpointAnalysisImatinib 1 yearPlaceboEffect
RFSRecurrence-free survival as named in the paperprimarymedian follow-up 19.7 monthsDematteo 200998% at 12 mo (96–100%)83% at 12 mo (78–88%)HR 0.35 (95% CI 0.22–0.53)P<0.0001One-sided p-value as published. Recurrence or death: 30 patients (8%) imatinib vs 70 (20%) placebo. Median follow-up range 0 to 56.4 months. Accrual stopped after a planned interim analysis crossed the efficacy boundary (interim HR 0.33, 95% CI 0.20 to 0.53 in the full text); these figures are from the paper's analysis of all data to 12 April 2007.
OSprimarymedian follow-up 19.7 monthsDematteo 2009——HR 0.66 (95% CI 0.22–2.03)P=0.4714Secondary endpoint; 13 deaths in 713 patients (5 imatinib, 8 placebo); the paper states there is no difference in overall survival at this time. The placebo arm is the hazard-ratio denominator. Read in the author manuscript (PMC2915459), not in the printed abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
RFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
RFS0.350.22–0.53
OS0.660.22–2.03
Primary publication: Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097-104. PubMedDOI

Appears in

Sources

  1. Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097-104.

    PubMedDOI