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PRODIGE 4 / ACCORD 11

FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer (PRODIGE 4 / ACCORD 11)

Phase 2/3N = 342NCT00112658

Population
Metastatic pancreatic cancer, ECOG performance status 0 or 1
Design
Randomised comparison of FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, fluorouracil; every 2 weeks) with gemcitabine in metastatic pancreatic cancer; six months of chemotherapy recommended in both groups in patients who had a response. Phase 2/3 per ClinicalTrials.gov NCT00112658 (the abstract does not state the phase).
Primary endpoint
OS
Arms
  • FOLFIRINOX (experimental): Oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, fluorouracil 400 mg/m2 bolus then 2400 mg/m2 over 46 hours, every 2 weeks
  • Gemcitabine (control): Gemcitabine 1000 mg/m2 weekly for 7 of 8 weeks, then weekly for 3 of 4 weeks
People
Conroy T
OSHR 0.57 (95% CI 0.45–0.73)Δ median OS+4.3 monthsPFSHR 0.47 (95% CI 0.37–0.59)Δ median PFS+3.1 monthsΔ ORR+22.2 points
Show the numbers
Results reported for PRODIGE 4 / ACCORD 11
EndpointAnalysisFOLFIRINOXGemcitabineEffect
OSRandomised patients (342)primaryConroy 2011median 11.1 monthsmedian 6.8 monthsHR 0.57 (95% CI 0.45–0.73)P<0.001
PFSRandomised patients (342)primaryConroy 2011median 6.4 monthsmedian 3.3 monthsHR 0.47 (95% CI 0.37–0.59)P<0.001
ORRRandomised patients (342)primaryConroy 201131.6%9.4%P<0.001
Results reported for PRODIGE 4 / ACCORD 11
EndpointAnalysisFOLFIRINOXGemcitabineEffect
OSRandomised patients (342)primaryConroy 2011median 11.1 monthsmedian 6.8 monthsHR 0.57 (95% CI 0.45–0.73)P<0.001
PFSRandomised patients (342)primaryConroy 2011median 6.4 monthsmedian 3.3 monthsHR 0.47 (95% CI 0.37–0.59)P<0.001
ORRRandomised patients (342)primaryConroy 201131.6%9.4%P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.570.45–0.73
PFS0.470.37–0.59
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • FOLFIRINOX (experimental)
  • Gemcitabine (control)

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

Data table (modelled values)
MonthsFOLFIRINOXGemcitabine
0100.0%100.0%
764.6%49.0%
1441.7%24.0%
2126.9%11.8%
2817.4%5.8%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • FOLFIRINOX (experimental)
  • Gemcitabine (control)

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

Data table (modelled values)
MonthsFOLFIRINOXGemcitabine
0100.0%100.0%
464.8%43.2%
842.0%18.6%
1227.3%8.0%
1617.7%3.5%
Primary publication: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-25. PubMedDOI

Appears in

Sources

  1. Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-25.

    PubMedDOI