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Bending the Curve Trial by Trial
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RECORD-1

RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib

Phase 3NCT00410124

Population
Metastatic renal cell carcinoma that had progressed on sunitinib, sorafenib or both
Design
Double-blind, randomised (2:1), placebo-controlled phase 3 trial of everolimus 10 mg once daily or placebo, each with best supportive care, in patients whose disease had progressed on sunitinib, sorafenib or both. Stratified by MSKCC prognostic score and previous therapy. Primary end point progression-free survival by blinded independent central review; planned to end after 290 progression events, halted at the second interim analysis after 191 events.
Primary endpoint
PFS
Arms
  • Everolimus (experimental, n = 272): Everolimus 10 mg orally once daily plus best supportive care
  • Placebo (control, n = 138): Placebo plus best supportive care
People
Motzer RJ, RECORD-1 Study Group
PFSHR 0.30 (95% CI 0.22–0.40)Δ median PFS+2.1 months
Show the numbers
Results reported for RECORD-1
EndpointAnalysisEverolimusPlaceboEffect
PFSinterimMotzer 2008median 4 months (3.7–5.5)median 1.9 months (1.8–1.9)HR 0.30 (95% CI 0.22–0.40)P<0.0001Second interim analysis, after which the trial was halted early; 191 progression events (101 in the everolimus group, 90 in the placebo group).
Results reported for RECORD-1
EndpointAnalysisEverolimusPlaceboEffect
PFSinterimMotzer 2008median 4 months (3.7–5.5)median 1.9 months (1.8–1.9)HR 0.30 (95% CI 0.22–0.40)P<0.0001Second interim analysis, after which the trial was halted early; 191 progression events (101 in the everolimus group, 90 in the placebo group).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.30.22–0.4
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%0246810Months (modelled)
  • Everolimus (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsEverolimusPlacebo
0100.0%100.0%
359.5%33.5%
542.0%16.1%
825.0%5.4%
1017.7%2.6%
Primary publication: Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008;372(9637):449-56. PubMedDOI

Appears in

Sources

  1. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008;372(9637):449-56.

    PubMedDOI