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Bending the Curve Trial by Trial
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CE.6

Short-course radiotherapy with or without temozolomide in elderly patients with newly diagnosed glioblastoma (CCTG CE.6 / EORTC 26062-22061)

Phase 3N = 562NCT00482677

Population
Patients aged 65 years or older with newly diagnosed glioblastoma; median age 73 years (range 65 to 90); 165 patients with methylated MGMT and 189 with unmethylated MGMT in the subgroup analyses
Design
Randomised phase 3 trial of radiotherapy alone (40 Gy in 15 fractions) versus the same radiotherapy with concomitant and adjuvant temozolomide; MGMT methylation status analysed in a subset
Arms
  • Short-course radiotherapy alone (control, n = 281): Radiotherapy 40 Gy in 15 fractions
  • Short-course radiotherapy plus temozolomide (experimental, n = 281): Radiotherapy 40 Gy in 15 fractions with concomitant and adjuvant temozolomide
People
Perry JR
OSHR 0.67 (95% CI 0.56–0.80)Δ median OS+1.7 monthsPFSHR 0.50 (95% CI 0.41–0.60)Δ median PFS+1.4 monthsOSHR 0.53 (95% CI 0.38–0.73)Δ median OS+5.8 months
Show the numbers
Results reported for CE.6
EndpointAnalysisShort-course radiotherapy plus temozolomideShort-course radiotherapy aloneEffect
OSAll randomised patients (n=562); analysis population not otherwise specified in the abstractprimaryPerry 2017median 9.3 monthsmedian 7.6 monthsHR 0.67 (95% CI 0.56–0.80)P<0.001
PFSAll randomised patients (n=562); analysis population not otherwise specified in the abstractprimaryPerry 2017median 5.3 monthsmedian 3.9 monthsHR 0.50 (95% CI 0.41–0.60)P<0.001
OSPatients with methylated MGMT (n=165)exploratoryPerry 2017median 13.5 monthsmedian 7.7 monthsHR 0.53 (95% CI 0.38–0.73)P<0.001MGMT subgroup; the abstract does not describe it as prespecified, so it is labelled exploratory here.
OSPatients with unmethylated MGMT (n=189)exploratoryPerry 2017median 10 monthsmedian 7.9 monthsHR 0.75 (95% CI 0.56–1.01)P=0.055P=0.08 for interaction between MGMT status and treatment effect, as printed in the abstract. MGMT subgroup; labelled exploratory here because the abstract does not say it was prespecified.
Results reported for CE.6
EndpointAnalysisShort-course radiotherapy plus temozolomideShort-course radiotherapy aloneEffect
OSAll randomised patients (n=562); analysis population not otherwise specified in the abstractprimaryPerry 2017median 9.3 monthsmedian 7.6 monthsHR 0.67 (95% CI 0.56–0.80)P<0.001
PFSAll randomised patients (n=562); analysis population not otherwise specified in the abstractprimaryPerry 2017median 5.3 monthsmedian 3.9 monthsHR 0.50 (95% CI 0.41–0.60)P<0.001
OSPatients with methylated MGMT (n=165)exploratoryPerry 2017median 13.5 monthsmedian 7.7 monthsHR 0.53 (95% CI 0.38–0.73)P<0.001MGMT subgroup; the abstract does not describe it as prespecified, so it is labelled exploratory here.
OSPatients with unmethylated MGMT (n=189)exploratoryPerry 2017median 10 monthsmedian 7.9 monthsHR 0.75 (95% CI 0.56–1.01)P=0.055P=0.08 for interaction between MGMT status and treatment effect, as printed in the abstract. MGMT subgroup; labelled exploratory here because the abstract does not say it was prespecified.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.670.56–0.8
PFS0.50.41–0.6
OS0.530.38–0.73
OS0.750.56–1.01
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Short-course radiotherapy plus temozolomide (experimental)
  • Short-course radiotherapy alone (control)

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

Data table (modelled values)
MonthsShort-course radiotherapy plus temozolomideShort-course radiotherapy alone
0100.0%100.0%
663.9%57.9%
1240.9%33.5%
1728.2%21.2%
2318.0%12.3%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Short-course radiotherapy plus temozolomide (experimental)
  • Short-course radiotherapy alone (control)

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

Data table (modelled values)
MonthsShort-course radiotherapy plus temozolomideShort-course radiotherapy alone
0100.0%100.0%
367.5%58.7%
740.0%28.8%
1027.0%16.9%
1318.3%9.9%
Primary publication: Perry JR, Laperriere N, O'Callaghan CJ, Brandes AA, Menten J, Phillips C, et al. Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. N Engl J Med. 2017;376(11):1027-1037. PubMedDOI

Appears in

Sources

  1. Perry JR, Laperriere N, O'Callaghan CJ, Brandes AA, Menten J, Phillips C, et al. Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. N Engl J Med. 2017;376(11):1027-1037.

    PubMedDOI