Table 4.
Effect of Tumor Marker Status on Treatment Outcome for DFS and OS
| Treatment Group | No. of Patients | DFS |
OS |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5-Year DFS | 95% CI | Log-Rank P | HR | 95% CI | 5-Year OS | 95% CI | Log-Rank P | HR | 95% CI | ||
| Stage II predictive analysis | |||||||||||
| Patients with MSI deficient tumors | |||||||||||
| Treated with MoAb 17-1A | 103 | 0.86 | 0.77 to 0.91 | .52 | 0.87 | 0.79 to 0.93 | .52 | ||||
| Observation | 96 | 0.82 | 0.72 to 0.88 | 1.21 | 0.68 to 2.18 | 0.86 | 0.77 to 0.91 | 1.22 | 0.66 to 2.26 | ||
| Patients with MSI intact tumors | |||||||||||
| Treated with MoAb 17-1A | 372 | 0.74 | 0.70 to 0.79 | .75 | 0.85 | 0.81 to 0.88 | .84 | ||||
| Observation | 364 | 0.76 | 0.71 to 0.80 | 0.96 | 0.74 to 1.24 | 0.83 | 0.79 to 0.87 | 1.03 | 0.78 to 1.37 | ||
| Patients with 18qLOH tumors | |||||||||||
| Treated with MoAb 17-1A | 118 | 0.76 | 0.67 to 0.83 | .06 | 0.88 | 0.80 to 0.92 | .26 | ||||
| Observation | 104 | 0.83 | 0.74 to 0.89 | 0.61 | 0.36 to 1.03 | 0.86 | 0.78 to 0.92 | 0.72 | 0.40 to 1.28 | ||
| Patients with 18q intact tumors | |||||||||||
| Treated with MoAb 17-1A | 43 | 0.74 | 0.57 to 0.85 | .99 | 0.82 | 0.66 to 0.91 | .60 | ||||
| Observation | 28 | 0.82 | 0.61 to 0.89 | 1.00 | 0.40 to 2.50 | 0.81 | 0.61 to 0.92 | 1.29 | 0.50 to 3.34 | ||
| Patients with noninformative tumors | |||||||||||
| Treated with MoAb 17-1A | 32 | 0.80 | 0.61 to 0.91 | .91 | 0.83 | 0.64 to 0.95 | .81 | ||||
| Observation | 28 | 0.80 | 0.58 to 0.91 | 0.94 | 0.32 to 2.80 | 0.88 | 0.67 to 0.96 | 0.86 | 0.26 to 2.84 | ||
| Stage III predictive analysis | |||||||||||
| Patients with MMR-D tumors | |||||||||||
| Treated with FU/LV | 62 | 0.60 | 0.46 to 0.71 | .18 | 0.71 | 0.57 to 0.81 | .62 | ||||
| Treated with IFL | 69 | 0.69 | 0.57 to 0.79 | 0.68 | 0.38 to 1.20 | 0.74 | 0.61 to 0.82 | 0.85 | 0.46 to 1.59 | ||
| Patients with MMR-I tumors | |||||||||||
| Treated with FU/LV | 395 | 0.61 | 0.56 to 0.65 | .44 | 0.73 | 0.68 to 0.77 | .78 | ||||
| Treated with IFL | 384 | 0.58 | 0.52 to 0.62 | 1.09 | 0.88 to 1.34 | 0.70 | 0.65 to 0.74 | 1.03 | 0.82 to 1.31 | ||
| Patients with 18qLOH tumors | |||||||||||
| Treated with FU/LV | 228 | 0.58 | 0.51 to 0.64 | .49 | 0.72 | 0.66 to 0.78 | .39 | ||||
| Treated with IFL | 217 | 0.59 | 0.52 to 0.65 | 0.90 | 0.68 to 1.20 | 0.71 | 0.65 to 0.77 | 0.87 | 0.64 to 1.19 | ||
| Patients with 18q intact tumors | |||||||||||
| Treated with FU/LV | 39 | 0.72 | 0.55 to 0.83 | .63 | 0.79 | 0.62 to 0.89 | .54 | ||||
| Treated with IFL | 40 | 0.69 | 0.52 to 0.81 | 1.20 | 0.58 to 2.45 | 0.81 | 0.64 to 0.90 | 0.76 | 0.32 to 1.81 | ||
| Patients with noninformative tumors | |||||||||||
| Treated with MoAb 17-1A | 35 | 0.60 | 0.42 to 0.74 | .51 | 0.69 | 0.50 to 0.81 | .57 | ||||
| Observation | 43 | 0.51 | 0.35 to 0.65 | 1.24 | 0.65 to 2.37 | 0.57 | 0.40 to 0.70 | 1.22 | 0.61 to 2.44 | ||
Abbreviations: 18qLOH, loss of heterozygosity at chromosomal location 18q; DFS, disease-free survival; FU/LV, fluorouracil plus leucovorin; HR, hazard ratio; IFL, fluorouracil, leucovorin, and irinotecan; MMR-D, mismatch repair deficiency; MMR-I, mismatch repair intact; MoAb 17-1A, monoclonal antibody 17-1A; MSI, microsatellite instability; OS, overall survival.