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CENTRIC

Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072)

Phase 3N = 545NCT00689221

Population
Adults with newly diagnosed, histologically proven supratentorial glioblastoma with methylated MGMT promoter; 3471 screened, 926 with methylated MGMT promoter, 545 randomised (272 cilengitide, 273 control)
Design
Multicentre, open-label phase 3 trial (146 sites in 25 countries); centrally randomised 1:1 to temozolomide chemoradiotherapy with cilengitide 2000 mg intravenously twice weekly (up to 18 months or until progression or unacceptable toxicity) or temozolomide chemoradiotherapy alone; maintenance temozolomide for up to six cycles; primary endpoint overall survival, analysed by intention to treat
Primary endpoint
OS
Arms
  • Cilengitide plus temozolomide chemoradiotherapy (experimental, n = 272): Temozolomide chemoradiotherapy plus cilengitide 2000 mg intravenously twice weekly
  • Temozolomide chemoradiotherapy alone (control, n = 273): Temozolomide chemoradiotherapy alone
People
Stupp R
OSHR 1.02 (95% CI 0.81–1.29)Δ median OS0 months
Show the numbers
Results reported for CENTRIC
EndpointAnalysisCilengitide plus temozolomide chemoradiotherapyTemozolomide chemoradiotherapy aloneEffect
OSOverall survival (primary endpoint)primaryStupp 2014median 26.3 months (23.8–28.8)median 26.3 months (23.9–34.7)HR 1.02 (95% CI 0.81–1.29)P=0.86
Results reported for CENTRIC
EndpointAnalysisCilengitide plus temozolomide chemoradiotherapyTemozolomide chemoradiotherapy aloneEffect
OSOverall survival (primary endpoint)primaryStupp 2014median 26.3 months (23.8–28.8)median 26.3 months (23.9–34.7)HR 1.02 (95% CI 0.81–1.29)P=0.86
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.020.81–1.29
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Cilengitide plus temozolomide chemoradiotherapy (experimental)
  • Temozolomide chemoradiotherapy alone (control)

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

Data table (modelled values)
MonthsCilengitide plus temozolomide chemoradiotherapyTemozolomide chemoradiotherapy alone
0100.0%100.0%
1665.6%65.6%
3341.9%41.9%
4927.5%27.5%
6617.6%17.6%
Primary publication: Stupp R, Hegi ME, Gorlia T, Erridge SC, Perry J, Hong YK, et al. Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(10):1100-8. PubMedDOI

Appears in

Sources

  1. Stupp R, Hegi ME, Gorlia T, Erridge SC, Perry J, Hong YK, et al. Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(10):1100-8.

    PubMedDOI