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EORTC 26101

Lomustine and bevacizumab in progressive glioblastoma (EORTC 26101)

Phase 3N = 437NCT01290939

Population
Patients with glioblastoma at first progression after chemoradiation; 437 randomised (288 lomustine plus bevacizumab, 149 lomustine alone)
Design
Randomised (2:1) open-label phase 3 trial of lomustine plus bevacizumab versus lomustine alone in patients with progression after chemoradiation; primary endpoint overall survival; MGMT promoter methylation, health-related quality of life and neurocognitive function also assessed
Primary endpoint
OS
Arms
  • Lomustine plus bevacizumab (experimental, n = 288): Lomustine plus bevacizumab; doses not given in the abstract
  • Lomustine alone (control, n = 149): Lomustine alone; dose not given in the abstract
People
Wick W, European Organisation for Research and Treatment of Cancer (EORTC)
OSHR 0.95 (95% CI 0.74–1.21)Δ median OS+0.5 monthsPFSHR 0.49 (95% CI 0.39–0.61)Δ median PFS+2.7 months
Show the numbers
Results reported for EORTC 26101
EndpointAnalysisLomustine plus bevacizumabLomustine aloneEffect
OSRandomised patients (n=437); analysis population not stated in the abstractOverall survival (primary endpoint)primaryWick 2017median 9.1 months (8.1–10.1)median 8.6 months (7.6–10.4)HR 0.95 (95% CI 0.74–1.21)P=0.65
PFSRandomised patients (n=437); analysis population not stated in the abstractLocally assessed progression-free survivalprimaryWick 2017median 4.2 monthsmedian 1.5 monthsHR 0.49 (95% CI 0.39–0.61)P<0.001Locally assessed, not centrally reviewed; reported alongside the primary endpoint.
Results reported for EORTC 26101
EndpointAnalysisLomustine plus bevacizumabLomustine aloneEffect
OSRandomised patients (n=437); analysis population not stated in the abstractOverall survival (primary endpoint)primaryWick 2017median 9.1 months (8.1–10.1)median 8.6 months (7.6–10.4)HR 0.95 (95% CI 0.74–1.21)P=0.65
PFSRandomised patients (n=437); analysis population not stated in the abstractLocally assessed progression-free survivalprimaryWick 2017median 4.2 monthsmedian 1.5 monthsHR 0.49 (95% CI 0.39–0.61)P<0.001Locally assessed, not centrally reviewed; reported alongside the primary endpoint.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.950.74–1.21
PFS0.490.39–0.61
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Lomustine plus bevacizumab (experimental)
  • Lomustine alone (control)

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

Data table (modelled values)
MonthsLomustine plus bevacizumabLomustine alone
0100.0%100.0%
663.3%61.7%
1143.3%41.2%
1727.4%25.4%
2317.3%15.7%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0246810Months (modelled)
  • Lomustine plus bevacizumab (experimental)
  • Lomustine alone (control)

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

Data table (modelled values)
MonthsLomustine plus bevacizumabLomustine alone
0100.0%100.0%
361.0%25.0%
543.8%9.9%
826.7%2.5%
1116.3%0.6%
Primary publication: Wick W, Gorlia T, Bendszus M, Taphoorn M, Sahm F, Harting I, et al. Lomustine and Bevacizumab in Progressive Glioblastoma. N Engl J Med. 2017;377(20):1954-1963. PubMedDOI

Appears in

Sources

  1. Wick W, Gorlia T, Bendszus M, Taphoorn M, Sahm F, Harting I, et al. Lomustine and Bevacizumab in Progressive Glioblastoma. N Engl J Med. 2017;377(20):1954-1963.

    PubMedDOI