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Bending the Curve Trial by Trial
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CALGB 80303

Gemcitabine plus bevacizumab versus gemcitabine plus placebo in advanced pancreatic cancer (CALGB 80303)

Phase 3N = 602NCT00088894

Population
Untreated advanced pancreatic cancer, ECOG 0 to 2
Design
Double-blind, placebo-controlled, randomised phase 3 trial: gemcitabine 1,000 mg/m2 on days 1, 8, 15 every 28 days with bevacizumab 10 mg/kg or placebo on days 1 and 15; no prior therapy for advanced disease, ECOG performance status 0 to 2. Primary end point overall survival. Registry id matched by CALGB-80303 secondary id and title.
Primary endpoint
OS
Arms
  • Gemcitabine plus bevacizumab (experimental): Gemcitabine 1,000 mg/m2 days 1, 8, 15 plus bevacizumab 10 mg/kg days 1 and 15 every 28 days
  • Gemcitabine plus placebo (control): Gemcitabine 1,000 mg/m2 days 1, 8, 15 plus placebo days 1 and 15 every 28 days
People
Kindler HL
Δ median OS−0.1 monthsΔ median PFS+0.9 monthsΔ ORR+3 points
Show the numbers
Results reported for CALGB 80303
EndpointAnalysisGemcitabine plus bevacizumabGemcitabine plus placeboEffect
OSAnalysis population not stated in the abstract (602 enrolled, 535 treated)primaryKindler 2010median 5.8 monthsmedian 5.9 monthsP=.95
PFSAnalysis population not stated in the abstract (602 enrolled, 535 treated)primaryKindler 2010median 3.8 monthsmedian 2.9 monthsP=.07
ORRAnalysis population not stated in the abstract (602 enrolled, 535 treated)primaryKindler 201013%10%—
Results reported for CALGB 80303
EndpointAnalysisGemcitabine plus bevacizumabGemcitabine plus placeboEffect
OSAnalysis population not stated in the abstract (602 enrolled, 535 treated)primaryKindler 2010median 5.8 monthsmedian 5.9 monthsP=.95
PFSAnalysis population not stated in the abstract (602 enrolled, 535 treated)primaryKindler 2010median 3.8 monthsmedian 2.9 monthsP=.07
ORRAnalysis population not stated in the abstract (602 enrolled, 535 treated)primaryKindler 201013%10%—
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Gemcitabine plus bevacizumab (experimental)
  • Gemcitabine plus placebo (control)

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

Data table (modelled values)
MonthsGemcitabine plus bevacizumabGemcitabine plus placebo
0100.0%100.0%
462.0%62.5%
743.3%43.9%
1126.9%27.5%
1516.7%17.2%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468Months (modelled)
  • Gemcitabine plus bevacizumab (experimental)
  • Gemcitabine plus placebo (control)

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

Data table (modelled values)
MonthsGemcitabine plus bevacizumabGemcitabine plus placebo
0100.0%100.0%
269.4%62.0%
540.2%30.3%
727.9%18.8%
1016.1%9.2%
Primary publication: Kindler HL, Niedzwiecki D, Hollis D, Sutherland S, Schrag D, Hurwitz H, et al. Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303). J Clin Oncol. 2010;28(22):3617-22. PubMedDOI

Appears in

Sources

  1. Kindler HL, Niedzwiecki D, Hollis D, Sutherland S, Schrag D, Hurwitz H, et al. Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303). J Clin Oncol. 2010;28(22):3617-22.

    PubMedDOI