Skip to content
Bending the Curve Trial by Trial
?

Gemcitabine versus fluorouracil as first-line therapy for advanced symptomatic pancreas cancer (randomised trial)

N = 126

Population
Newly diagnosed advanced symptomatic pancreas cancer
Design
Randomised comparison in newly diagnosed advanced symptomatic pancreas cancer after a lead-in period to characterise and stabilise pain. Gemcitabine 1,000 mg/m2 weekly for 7 weeks, then weekly for 3 of every 4 weeks, versus fluorouracil 600 mg/m2 once weekly. Primary efficacy measure: clinical benefit response (composite of pain, Karnofsky performance status and weight). Blinding, phase and registry identifiers are not stated in the abstract; the trial predates registration (no registry id found).
Primary endpoint
Clinical benefit response
Arms
  • Gemcitabine (experimental, n = 63): Gemcitabine 1,000 mg/m2 weekly x 7 then 1 week rest, then weekly x 3 every 4 weeks
  • Fluorouracil (control, n = 63): Fluorouracil 600 mg/m2 once weekly
People
Burris HA 3rd
Δ Clinical benefit response+19 pointsΔ median OS+1.24 monthsΔ 12-month OS+16 points
Show the numbers
Results reported for Gemcitabine versus fluorouracil as first-line therapy for advanced symptomatic pancreas cancer (randomised trial)
EndpointAnalysisGemcitabineFluorouracilEffect
Clinical benefit responseRandomised patients (126)Composite of pain (analgesic consumption, pain intensity), Karnofsky performance status and weight; required a sustained (4 weeks or longer) improvement in at least one parameter without worsening in any otherprimaryBurris 199723.8%4.8%P=.0022
OSRandomised patients (126)Median survival (a further efficacy measure; clinical benefit response was the primary measure)primaryBurris 1997median 5.65 months; 18% at 12 momedian 4.41 months; 2% at 12 moP=.0025P value is for the median survival comparison; no hazard ratio is given in the abstract. Survival at 12 months: 18% versus 2%.
Results reported for Gemcitabine versus fluorouracil as first-line therapy for advanced symptomatic pancreas cancer (randomised trial)
EndpointAnalysisGemcitabineFluorouracilEffect
Clinical benefit responseRandomised patients (126)Composite of pain (analgesic consumption, pain intensity), Karnofsky performance status and weight; required a sustained (4 weeks or longer) improvement in at least one parameter without worsening in any otherprimaryBurris 199723.8%4.8%P=.0022
OSRandomised patients (126)Median survival (a further efficacy measure; clinical benefit response was the primary measure)primaryBurris 1997median 5.65 months; 18% at 12 momedian 4.41 months; 2% at 12 moP=.0025P value is for the median survival comparison; no hazard ratio is given in the abstract. Survival at 12 months: 18% versus 2%.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Gemcitabine (experimental)
  • Fluorouracil (control)

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

Data table (modelled values)
MonthsGemcitabineFluorouracil
0100.0%100.0%
461.2%53.3%
742.4%33.3%
1125.9%17.7%
1418.0%11.1%
Primary publication: Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15(6):2403-13. PubMedDOI

Appears in

Sources

  1. Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15(6):2403-13.

    PubMedDOI