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Bending the Curve Trial by Trial
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RTOG 0525

Dose-dense versus standard temozolomide after chemoradiation in newly diagnosed glioblastoma (RTOG 0525)

Phase 3N = 833NCT00304031

Population
Patients older than 18 years with newly diagnosed glioblastoma, Karnofsky performance score of 60 or higher and adequate tissue; 1,173 registered, 833 randomly assigned
Design
Randomised phase 3 trial of standard temozolomide (arm 1) versus dose-dense temozolomide (arm 2) for 6 to 12 cycles; stratified by clinical factors and tumour MGMT methylation status; primary endpoint overall survival
Primary endpoint
OS
Arms
  • Standard temozolomide (control): Standard-schedule temozolomide for 6 to 12 cycles (arm 1)
  • Dose-dense temozolomide (experimental): Dose-dense temozolomide for 6 to 12 cycles (arm 2); the schedule is not given in the abstract
People
Gilbert MR, senior author Mehta MP, Radiation Therapy Oncology Group
OSHR 1.03Δ median OS−1.7 monthsPFSHR 0.87Δ median PFS+1.2 months
Show the numbers
Results reported for RTOG 0525
EndpointAnalysisDose-dense temozolomideStandard temozolomideEffect
OSRandomly assigned patients (n=833); analysis population not stated in the abstractprimaryGilbert 2013median 14.9 monthsmedian 16.6 monthsHR 1.03P=.63Hazard ratio as printed in the abstract without a confidence interval. Efficacy did not differ by MGMT methylation status.
PFSRandomly assigned patients (n=833); analysis population not stated in the abstractprimaryGilbert 2013median 6.7 monthsmedian 5.5 monthsHR 0.87P=.06The abstract names overall survival as the primary end point; progression-free survival is reported alongside it. The abstract reports no statistically significant difference between arms.
Results reported for RTOG 0525
EndpointAnalysisDose-dense temozolomideStandard temozolomideEffect
OSRandomly assigned patients (n=833); analysis population not stated in the abstractprimaryGilbert 2013median 14.9 monthsmedian 16.6 monthsHR 1.03P=.63Hazard ratio as printed in the abstract without a confidence interval. Efficacy did not differ by MGMT methylation status.
PFSRandomly assigned patients (n=833); analysis population not stated in the abstractprimaryGilbert 2013median 6.7 monthsmedian 5.5 monthsHR 0.87P=.06The abstract names overall survival as the primary end point; progression-free survival is reported alongside it. The abstract reports no statistically significant difference between arms.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Standard temozolomide (control)
  • Dose-dense temozolomide (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsStandard temozolomideDose-dense temozolomide
0100.0%100.0%
1065.9%62.8%
2141.6%37.6%
3127.4%23.6%
4217.3%14.2%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Standard temozolomide (control)
  • Dose-dense temozolomide (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsStandard temozolomideDose-dense temozolomide
0100.0%100.0%
460.4%66.1%
836.5%43.7%
1319.4%26.1%
1711.7%17.2%
Primary publication: Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, et al. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013;31(32):4085-91. PubMedDOI

Appears in

Sources

  1. Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, et al. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013;31(32):4085-91.

    PubMedDOI