Table 1.
Patient and Tumor Characteristics for 393 Patients in the Study Cohort, 1,061 Eligible Patients Not in the Study Cohort, and Total 1,454 Eligible Patients From the Parent Trial
| Characteristic | Value | Eligible Included in Study (n = 393)* | Eligible Patients Not Included in Study (n = 1,061)* | Parent C9581 Trial Eligible Patients (N = 1,454)* |
|---|---|---|---|---|
| No. (%)†‡ | No. (%)†‡ | No. (%)† | ||
| Age | Years | 64 (23) | 64 (13) | 64 (11) |
| Sex | Male | 209 (53) | 554 (52) | 763 (52) |
| Race/ethnicity | White | 357 (91) | 971 (91) | 1,328 (92) |
| (n = 392) | (n = 1,057) | (n = 1,449) | ||
| Treatment arm | Edrecolomab | 192 (49) | 528 (50) | 720 (50) |
| T stage | T4 | 18 (5) | 35 (3) | 53 (4) |
| Nodes examined | No. | 14.5 (17) | 14.7 (12) | 14.6 (9) |
| Perineural invasion | Present | 10 (2) | 27 (3) | 37 (3) |
| (n = 391) | (n = 1,056) | (n = 1,447) | ||
| Lymphovascular invasion | Present | 47 (11) | 115 (11) | 162 (11) |
| Tumor grade | High | 67 (17) | 148 (14) | 215 (15) |
| (n = 1,054) | (n = 1,447) | |||
| Obstruction or perforation | Present | 6 (2) | 20 (2) | 26 (2) |
| (n = 1,060) | (n = 1,453) | |||
| Tumor location | Proximal | 244 (62) | 634 (59) | 878 (60) |
| (n = 1,060) | (n = 1,453) | |||
| MMR status§ | Deficient | 94 (26) | 84 (18) | 178 (21) |
| (n = 377) | (n = 456) | (n = 833) |
Abbreviation: MMR, mismatch repair.
*
Sample size unless otherwise specified.
†
Denotes mean and standard deviation for age and nodes examined.
‡
Percentages weighted to reflect those in the entire eligible cohort (N = 1,454).12
§
MMR as determined by immunohistochemistry on mut L homolog 1 (MLH1), mut S homolog 2 (MSH2).