Table 3.

Univariate predictive effects of TOP1 status in relation to OS

OS
Patients, nEvents, n5-Year rate95% CIHR (95% CI)PWaldPlog rank
TOP1 FISH stage II + III534
TOP1 signals per cell ≥ 4142
  5FU/FA70150.860.78–0.94
  5FU/FA + irinotecan72120.840.76–0.930.78 (0.63–1.66)0.510.51
TOP1 signals per cell < 4392
  5FU/FA188440.770.72–0.84
  5FU/FA + irinotecan204490.770.71–0.831.06 (0.70–1.59)0.790.79
TOP1/CEN20 ≥ 1.5167
  5FU/FA83150.850.78–0.93
  5FU/FA + irinotecan84140.830.75–0.910.95 (0.46–1.96)0.880.88
TOP1/CEN20 < 1.5367
  5FU/FA175440.770.71–0.83
  5FU/FA + irinotecan192470.770.71–0.830.99 (0.66–1.49)0.960.96
TOP1 FISH stage III368
TOP1 signals per cell ≥ 495
  5FU/FA47120.830.73–0.94
  5FU/FA + irinotecan4890.830.73–0.940.72 (0.30–1.70)0.450.45
TOP1 signals per cell < 4273
  5FU/FA132360.730.66–0.81
  5FU/FA + irinotecan141440.700.63–0.781.20 (0.77–1.86)0.420.42
TOP1/CEN20 ≥ 1.5120
  5FU/FA61150.800.70–0.91
  5FU/FA + irinotecan59120.790.70–0.910.83 (0.39–1.78)0.630.63
TOP1/CEN20 < 1.5248
  5FU/FA118330.730.66–0.82
  5FU/FA + irinotecan130410.700.63–0.791.17 (0.74–1.84)0.510.51
TOP1 mRNA expression stage III580
TOP1 high140
  5FU/FA73240.720.62–0.83
  5FU/FA + irinotecan67120.830.75–0.930.51 (0.25–1.02)0.0560.049
TOP1 normal440
  5FU/FA206610.740.68–0.80
  5FU/FA + irinotecan234690.710.66–0.771.04 (0.74–1.46)0.830.83

NOTE: The relative treatment effects (hazard ratios) are for 5FU/FA + irinotecan vs. 5FU/FA. The P values from the Wald test relate to the hazard ratios, whereas the P values from the log rank test relate to the estimated Kaplan–Meier functions for the two treatment groups within each TOP1 subgroup. Cutoff value for high TOP1 mRNA expression: ≥ third quartile of the observed TOP1 expression values.