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Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients

Phase meta-analysisN = 1,640

Population
Patients with unresectable or metastatic GIST (1,640 across the two studies)
Design
Meta-analysis of the two large randomised cooperative-group studies comparing imatinib 400 mg daily with 400 mg twice daily: EORTC 62005 (946 patients) and S0033 (694 eligible patients; ineligible patients were excluded for S0033 only), 1,640 in total. KIT/PDGFRA mutation status was available for a subset of 772 patients. Univariate and multivariate models; endpoints PFS and OS.
Primary endpoint
PFS, OS
Arms
  • Imatinib 400 mg daily (control, n = 818): Imatinib 400 mg once daily
  • Imatinib 400 mg twice daily (experimental, n = 822): Imatinib 400 mg twice daily
People
Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST), MetaGIST
PFSHR 0.89 (95% CI 0.79–1.00)OSHR 1
Show the numbers
Results reported for Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients
EndpointAnalysisImatinib 400 mg twice dailyImatinib 400 mg dailyEffect
PFSPooled patients from the two trials (n=1,640)primarymedian follow-up 45 monthsGastrointestinal 2010——HR 0.89 (95% CI 0.79–1.00)P=0.04Estimated hazard ratio for the high-dose (800 mg/day) arm; P from the Wald test. The abstract describes a 'small but significant' PFS advantage without giving the hazard ratio. In patients with KIT exon 9 mutations PFS was longer on high dose (P=.017, Wald).
OSPooled patients from the two trials (n=1,640)primarymedian follow-up 45 monthsGastrointestinal 2010——HR 1P=0.97No difference between the arms; the abstract reports OS as identical.
Results reported for Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients
EndpointAnalysisImatinib 400 mg twice dailyImatinib 400 mg dailyEffect
PFSPooled patients from the two trials (n=1,640)primarymedian follow-up 45 monthsGastrointestinal 2010——HR 0.89 (95% CI 0.79–1.00)P=0.04Estimated hazard ratio for the high-dose (800 mg/day) arm; P from the Wald test. The abstract describes a 'small but significant' PFS advantage without giving the hazard ratio. In patients with KIT exon 9 mutations PFS was longer on high dose (P=.017, Wald).
OSPooled patients from the two trials (n=1,640)primarymedian follow-up 45 monthsGastrointestinal 2010——HR 1P=0.97No difference between the arms; the abstract reports OS as identical.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.890.79–1
Primary publication: Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28(7):1247-53. PubMedDOI

Appears in

Sources

  1. Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28(7):1247-53.

    PubMedDOI