Table 1.
Demographics and Clinical Characteristics of the Study Cohort
| Characteristic | Stage II Patients: CALGB 9581 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MMR-D |
18qLOH |
|||||||||
| Analyzed |
Not Analyzed |
P | Analyzed |
Not Analyzed |
P | |||||
| No. | % | No. | % | No. | % | No. | % | |||
| No. of patients | 939 | 799 | 353 | 1,385 | ||||||
| Treatment | .35 | .039 | ||||||||
| MoAb 17-1A | 477 | 50.8 | 388 | 48.6 | 193 | 54.7 | 672 | 48.5 | ||
| Observation | 462 | 49.2 | 411 | 51.4 | 160 | 45.3 | 713 | 51.5 | ||
| Age, years | .09 | .74 | ||||||||
| Mean | 65 | 64 | 64 | 64 | ||||||
| Range | 30–90 | 24–88 | 33–89 | 24–90 | ||||||
| Sex | .62 | .23 | ||||||||
| Female | 447 | 47.6 | 390 | 48.8 | 160 | 45.3 | 677 | 48.9 | ||
| Male | 492 | 52.4 | 409 | 51.2 | 193 | 54.7 | 708 | 51.1 | ||
| Tumor location | .87 | < .001 | ||||||||
| Distal | 367 | 39.2 | 304 | 38.8 | 169 | 48.0 | 502 | 36.7 | ||
| Proximal | 569 | 60.1 | 479 | 61.2 | 183 | 52.0 | 865 | 63.3 | ||
| Tumor differentiation | .98 | .049 | ||||||||
| Well | 80 | 8.6 | 66 | 8.4 | 33 | 9.4 | 113 | 8.3 | ||
| Moderate | 709 | 70.0 | 596 | 75.8 | 278 | 79.2 | 1,027 | 75.0 | ||
| Poor/undifferentiated | 144 | 15.4 | 124 | 15.8 | 40 | 11.4 | 228 | 16.7 | ||
| Mean No. of nodes sampled | 14.0 | 14.8 | .12 | 13.6 | 14.6 | .07 | ||||
| Stage III Patients: CALGB 89803 |
||||||||||
| MMR-D |
18qLOH |
|||||||||
| Analyzed |
Not Analyzed |
Analyzed |
Not Analyzed |
|||||||
| No. |
% |
No. |
% |
P |
No. |
% |
No. |
% |
P |
|
| No. of patients | 913 | 351 | 602 | 662 | ||||||
| Treatment | .65 | .78 | ||||||||
| FU/LV | 458 | 50.2 | 171 | 48.7 | 302 | 50.2 | 327 | 49.4 | ||
| IFL | 455 | 49.8 | 180 | 51.3 | 300 | 49.8 | 335 | 50.6 | ||
| Age, years | .97 | .91 | ||||||||
| Mean | 60 | 60 | 60 | 60 | ||||||
| Range | 21–85 | 26–82 | 24–85 | 21–85 | ||||||
| Sex | .25 | .33 | ||||||||
| Female | 415 | 45.5 | 147 | 41.9 | 2,590 | 43.0 | 303 | 45.8 | ||
| Male | 498 | 54.5 | 204 | 58.1 | 343 | 57.0 | 359 | 54.2 | ||
| Tumor location | .84 | < .001 | ||||||||
| Distal | 382 | 42.4 | 139 | 41.7 | 286 | 48.0 | 235 | 36.8 | ||
| Proximal | 519 | 57.6 | 194 | 58.3 | 310 | 52.0 | 403 | 63.2 | ||
| Tumor differentiation | .93 | < .001 | ||||||||
| Well | 50 | 5.5 | 20 | 6.0 | 32 | 5.4 | 38 | 6.0 | ||
| Moderate | 629 | 69.7 | 232 | 69.9 | 451 | 75.5 | 410 | 64.3 | ||
| Poor/undifferentiated | 224 | 24.8 | 80 | 24.1 | 114 | 19.1 | 190 | 29.8 | ||
| Positive nodes | .66 | .48 | ||||||||
| Mean | 3.6 | 3.5 | 3.6 | 3.6 | ||||||
| Range | 1–29 | 0–22 | 1–24 | 0–29 | ||||||
| Nodal ratio | .44 | .43 | ||||||||
| Mean | 0.30 | 0.31 | 0.31 | 0.30 | ||||||
| Range | 0–1 | 0–1 | 0–1 | 0–1 | ||||||
| Nodes sampled | .14 | .019 | ||||||||
| Mean | 14.6 | 13.8 | 13.8 | 15 | ||||||
| Range | 1–99 | 1–68 | 1–99 | 1–68 | ||||||
Abbreviations: 18qLOH, loss of heterozygosity at chromosomal location 18q; CALGB, Cancer and Leukemia Group B; FU/LV, fluorouracil plus leucovorin; IFL, fluorouracil, leucovorin, and irinotecan; MMR-D, mismatch repair deficiency; MoAb 17-1A, monoclonal antibody 17-1A.