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Bending the Curve Trial by Trial
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AVADO

Bevacizumab plus docetaxel versus placebo plus docetaxel for first-line treatment of HER2-negative metastatic breast cancer

Phase 3N = 736NCT00333775

Population
HER2-negative locally recurrent or metastatic breast cancer, first-line
Design
Three-arm, placebo-controlled phase 3 trial: docetaxel 100 mg per square metre every 3 weeks plus placebo, bevacizumab 7.5 mg per kilogram or bevacizumab 15 mg per kilogram.
Primary endpoint
PFS
Arms
  • Docetaxel plus placebo (control): Docetaxel 100 mg/m2 plus placebo every 3 weeks
  • Docetaxel plus bevacizumab 7.5 mg/kg (experimental): Docetaxel 100 mg/m2 plus bevacizumab 7.5 mg/kg every 3 weeks
  • Docetaxel plus bevacizumab 15 mg/kg (experimental): Docetaxel 100 mg/m2 plus bevacizumab 15 mg/kg every 3 weeks
People
Miles DW, senior author Romieu G
PFSHR 0.77Δ median PFS+1.9 monthsPFSHR 0.67Δ median PFS+1.9 monthsPFSHR 0.86Δ median PFS+0.8 months
Show the numbers
Results reported for AVADO
EndpointAnalysisDocetaxel plus bevacizumab 7.5 mg/kg / Docetaxel plus bevacizumab 15 mg/kgDocetaxel plus placeboEffect
PFSBevacizumab 15 mg/kg versus placebo (unstratified analysis)primaryMiles 2010median 10.1 monthsmedian 8.2 monthsHR 0.77P=0.006
PFSBevacizumab 15 mg/kg versus placebo (stratified analysis)primaryMiles 2010median 10 monthsmedian 8.1 monthsHR 0.67P<0.001
PFSBevacizumab 7.5 mg/kg versus placebo (unstratified analysis)primaryMiles 2010median 9 monthsmedian 8.2 monthsHR 0.86P=0.12
PFSBevacizumab 7.5 mg/kg versus placebo (stratified analysis)primaryMiles 2010median 9 monthsmedian 8.1 monthsHR 0.8P=0.045
Results reported for AVADO
EndpointAnalysisDocetaxel plus bevacizumab 7.5 mg/kg / Docetaxel plus bevacizumab 15 mg/kgDocetaxel plus placeboEffect
PFSBevacizumab 15 mg/kg versus placebo (unstratified analysis)primaryMiles 2010median 10.1 monthsmedian 8.2 monthsHR 0.77P=0.006
PFSBevacizumab 15 mg/kg versus placebo (stratified analysis)primaryMiles 2010median 10 monthsmedian 8.1 monthsHR 0.67P<0.001
PFSBevacizumab 7.5 mg/kg versus placebo (unstratified analysis)primaryMiles 2010median 9 monthsmedian 8.2 monthsHR 0.86P=0.12
PFSBevacizumab 7.5 mg/kg versus placebo (stratified analysis)primaryMiles 2010median 9 monthsmedian 8.1 monthsHR 0.8P=0.045
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Docetaxel plus placebo (control)
  • Docetaxel plus bevacizumab 15 mg/kg (experimental)

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

Data table (modelled values)
MonthsDocetaxel plus placeboDocetaxel plus bevacizumab 15 mg/kg
0100.0%100.0%
660.2%66.2%
1333.3%41.0%
1920.1%27.1%
2512.1%18.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Docetaxel plus placebo (control)
  • Docetaxel plus bevacizumab 15 mg/kg (experimental)

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

Data table (modelled values)
MonthsDocetaxel plus placeboDocetaxel plus bevacizumab 15 mg/kg
0100.0%100.0%
659.8%66.0%
1332.9%40.6%
1919.7%26.8%
2511.8%17.7%
Primary publication: Miles DW, Chan A, Dirix LY, Cortés J, Pivot X, Tomczak P, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010;28(20):3239-47. PubMedDOI

Appears in

Sources

  1. Miles DW, Chan A, Dirix LY, Cortés J, Pivot X, Tomczak P, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010;28(20):3239-47.

    PubMedDOI