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OPTIMOX1

OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study

N = 620

Population
Previously untreated advanced colorectal cancer
Design
Randomised study in previously untreated advanced colorectal cancer: FOLFOX4 every 2 weeks until progression (arm A) versus FOLFOX7 for six cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 (arm B). 620 patients were enrolled, including an exploratory cohort of 95 elderly or poor-prognosis patients.
Arms
  • Arm A: FOLFOX4 until progression (control): FOLFOX4 every 2 weeks until progression
  • Arm B: FOLFOX7 stop-and-go (experimental): FOLFOX7 for six cycles, maintenance without oxaliplatin for 12 cycles, then reintroduction of FOLFOX7
People
Tournigand C
Δ median PFS−0.3 monthsΔ median OS+1.9 monthsΔ ORR+0.7 points
Show the numbers
Results reported for OPTIMOX1
EndpointAnalysisArm B: FOLFOX7 stop-and-goArm A: FOLFOX4 until progressionEffect
PFSEnrolled patients as reported (620, including an exploratory cohort of 95; analysis population not stated in the abstract)primaryTournigand 2006median 8.7 monthsmedian 9 monthsThe abstract reports P = not significant for progression-free survival and overall survival; no hazard ratio or interval is given.
OSEnrolled patients as reported (620, including an exploratory cohort of 95; analysis population not stated in the abstract)primaryTournigand 2006median 21.2 monthsmedian 19.3 monthsThe abstract reports P = not significant for progression-free survival and overall survival; no hazard ratio or interval is given.
ORREnrolled patients as reported (analysis population not stated in the abstract)primaryTournigand 200659.2%58.5%—
Results reported for OPTIMOX1
EndpointAnalysisArm B: FOLFOX7 stop-and-goArm A: FOLFOX4 until progressionEffect
PFSEnrolled patients as reported (620, including an exploratory cohort of 95; analysis population not stated in the abstract)primaryTournigand 2006median 8.7 monthsmedian 9 monthsThe abstract reports P = not significant for progression-free survival and overall survival; no hazard ratio or interval is given.
OSEnrolled patients as reported (620, including an exploratory cohort of 95; analysis population not stated in the abstract)primaryTournigand 2006median 21.2 monthsmedian 19.3 monthsThe abstract reports P = not significant for progression-free survival and overall survival; no hazard ratio or interval is given.
ORREnrolled patients as reported (analysis population not stated in the abstract)primaryTournigand 200659.2%58.5%—
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Arm A: FOLFOX4 until progression (control)
  • Arm B: FOLFOX7 stop-and-go (experimental)

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

Data table (modelled values)
MonthsArm A: FOLFOX4 until progressionArm B: FOLFOX7 stop-and-go
0100.0%100.0%
663.0%62.0%
1142.9%41.6%
1727.0%25.8%
2317.0%16.0%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Arm A: FOLFOX4 until progression (control)
  • Arm B: FOLFOX7 stop-and-go (experimental)

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

Data table (modelled values)
MonthsArm A: FOLFOX4 until progressionArm B: FOLFOX7 stop-and-go
0100.0%100.0%
1362.7%65.4%
2737.9%41.4%
4023.8%27.0%
5314.9%17.7%
Primary publication: Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, et al. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006;24(3):394-400. PubMedDOI

Appears in

Sources

  1. Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, et al. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006;24(3):394-400.

    PubMedDOI