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Bending the Curve Trial by Trial
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Radiotherapy plus supportive care versus supportive care alone in patients aged 70 years or older with glioblastoma (Keime-Guibert 2007)

Phase 3N = 85NCT00430911

Population
Patients aged 70 years or older with newly diagnosed anaplastic astrocytoma or glioblastoma and a Karnofsky performance score of 70 or higher; 85 randomised, 81 with glioblastoma analysed (median age 73 years)
Design
Randomised multicentre trial (10 centres): supportive care only versus supportive care plus focal radiotherapy (1.8 Gy daily fractions, 5 days a week, 50 Gy in total); primary endpoint overall survival; discontinued at the first interim analysis after a preset efficacy boundary was crossed; final analysis in the 81 patients with glioblastoma
Primary endpoint
OS
Arms
  • Supportive care alone (control, n = 42): Supportive care only (glioblastoma analysis: 42 patients)
  • Radiotherapy plus supportive care (experimental, n = 39): Focal radiotherapy 1.8 Gy daily fractions, 5 days a week, total 50 Gy, plus supportive care (glioblastoma analysis: 39 patients)
People
Keime-Guibert F, senior author Delattre JY, Association of French-Speaking Neuro-Oncologists
OSHR 0.47 (95% CI 0.29–0.76)
Show the numbers
Results reported for Radiotherapy plus supportive care versus supportive care alone in patients aged 70 years or older with glioblastoma (Keime-Guibert 2007)
EndpointAnalysisRadiotherapy plus supportive careSupportive care aloneEffect
OSPatients with glioblastoma in the final analysis (n=81: 39 radiotherapy, 42 supportive care alone)finalKeime-Guibert 2007——HR 0.47 (95% CI 0.29–0.76)P=0.002The abstract gives median survival in weeks, not months: 29.1 weeks with radiotherapy plus supportive care and 16.9 weeks with supportive care alone; median follow-up 21 weeks. Quality-of-life and cognitive evaluations over time did not differ significantly between groups.
Results reported for Radiotherapy plus supportive care versus supportive care alone in patients aged 70 years or older with glioblastoma (Keime-Guibert 2007)
EndpointAnalysisRadiotherapy plus supportive careSupportive care aloneEffect
OSPatients with glioblastoma in the final analysis (n=81: 39 radiotherapy, 42 supportive care alone)finalKeime-Guibert 2007——HR 0.47 (95% CI 0.29–0.76)P=0.002The abstract gives median survival in weeks, not months: 29.1 weeks with radiotherapy plus supportive care and 16.9 weeks with supportive care alone; median follow-up 21 weeks. Quality-of-life and cognitive evaluations over time did not differ significantly between groups.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.470.29–0.76
Primary publication: Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, et al. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007;356(15):1527-35. PubMedDOI

Appears in

Sources

  1. Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, et al. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007;356(15):1527-35.

    PubMedDOI