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Bending the Curve Trial by Trial
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E2100

Paclitaxel plus bevacizumab versus paclitaxel alone as initial treatment for metastatic breast cancer

Phase 3N = 722NCT00028990

Population
Metastatic breast cancer, initial treatment
Design
Open-label randomised phase 3 trial: paclitaxel 90 mg per square metre on days 1, 8 and 15 every 4 weeks, alone or with bevacizumab 10 mg per kilogram on days 1 and 15. Enrolled December 2001 to May 2004.
Primary endpoint
PFS
Arms
  • Paclitaxel plus bevacizumab (experimental): Paclitaxel 90 mg/m2 days 1, 8, 15 plus bevacizumab 10 mg/kg days 1 and 15, every 4 weeks
  • Paclitaxel alone (control): Paclitaxel 90 mg/m2 days 1, 8, 15 every 4 weeks
People
Miller K, senior author Davidson NE
PFSHR 0.6Δ median PFS+5.9 monthsΔ ORR+15.7 pointsOSHR 0.88Δ median OS+1.5 months
Show the numbers
Results reported for E2100
EndpointAnalysisPaclitaxel plus bevacizumabPaclitaxel aloneEffect
PFSprimaryMiller 2007median 11.8 monthsmedian 5.9 monthsHR 0.6P<0.001Grade 3 or 4 hypertension 14.8% vs 0.0%, proteinuria 3.6% vs 0.0%, cerebrovascular ischemia 1.9% vs 0.0%; infection 9.3% vs 2.9%.
ORRprimaryMiller 200736.9%21.2%P<0.001
OSprimaryMiller 2007median 26.7 monthsmedian 25.2 monthsHR 0.88P=0.16Overall survival was a secondary endpoint.
Results reported for E2100
EndpointAnalysisPaclitaxel plus bevacizumabPaclitaxel aloneEffect
PFSprimaryMiller 2007median 11.8 monthsmedian 5.9 monthsHR 0.6P<0.001Grade 3 or 4 hypertension 14.8% vs 0.0%, proteinuria 3.6% vs 0.0%, cerebrovascular ischemia 1.9% vs 0.0%; infection 9.3% vs 2.9%.
ORRprimaryMiller 200736.9%21.2%P<0.001
OSprimaryMiller 2007median 26.7 monthsmedian 25.2 monthsHR 0.88P=0.16Overall survival was a secondary endpoint.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Paclitaxel plus bevacizumab (experimental)
  • Paclitaxel alone (control)

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

Data table (modelled values)
MonthsPaclitaxel plus bevacizumabPaclitaxel alone
0100.0%100.0%
766.3%43.9%
1541.4%17.2%
2227.5%7.5%
3017.2%2.9%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Paclitaxel plus bevacizumab (experimental)
  • Paclitaxel alone (control)

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

Data table (modelled values)
MonthsPaclitaxel plus bevacizumabPaclitaxel alone
0100.0%100.0%
1764.3%62.7%
3342.5%40.3%
5027.3%25.3%
6717.6%15.8%
Primary publication: Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357(26):2666-76. PubMedDOI

Appears in

Sources

  1. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357(26):2666-76.

    PubMedDOI