Table. Patient and Tumor Characteristics at Baseline: NRG-GI002 Study.
| Patient or tumor characteristic | No. (%) of patients | P value | ||
|---|---|---|---|---|
| CA (n = 95) | PA (n = 90) | Total (n = 185) | ||
| Sex | ||||
| Female | 29 (30.5) | 30 (33.3) | 59 (31.9) | .75 |
| Male | 66 (69.5) | 60 (66.7) | 126 (68.1) | |
| Age, y | ||||
| <50 | 30 (31.6) | 25 (27.8) | 55 (29.7) | .76 |
| 50-59 | 28 (29.5) | 33 (36.7) | 61 (33.0) | |
| 60-69 | 30 (31.6) | 27 (30.0) | 57 (30.8) | |
| ≥70 | 7 (7.4) | 5 (5.6) | 12 (6.5) | |
| Race | ||||
| White | 77 (81.1) | 77 (85.6) | 154 (83.2) | .22 |
| American Indian or Alaska Native | 2 (2.1) | 1 (1.1) | 3 (1.6) | |
| Asian | 4 (4.2) | 3 (3.3) | 7 (3.8) | |
| Black or African American | 6 (6.3) | 2 (2.2) | 8 (4.3) | |
| Not reported | 3 (3.2) | 4 (4.4) | 7 (3.8) | |
| Unknown | 3 (3.2) | 3 (3.3) | 6 (3.2) | |
| Ethnicity | ||||
| Hispanic or Latino | 5 (5.3) | 9 (10.0) | 14 (7.6) | .28 |
| Not Hispanic or Latino | 83 (87.4) | 78 (86.7) | 161 (87.0) | |
| Not reported | 4 (4.2) | 2 (2.2) | 6 (3.2) | |
| Unknown | 3 (3.2) | 1 (1.1) | 4 (2.2) | |
| Distal location | ||||
| No | 27 (28.4) | 25 (27.8) | 52 (28.1) | >.99 |
| Yes | 68 (71.6) | 65 (72.2) | 133 (71.9) | |
| Bulky disease | ||||
| No | 40 (42.1) | 30 (33.3) | 70 (37.8) | .23 |
| Yes | 55 (57.9) | 60 (66.7) | 115 (62.2) | |
| High risk of metastatic disease | ||||
| No | 58 (61.1) | 55 (61.1) | 113 (61.1) | >.99 |
| Yes | 37 (38.9) | 35 (38.9) | 72 (38.9) | |
| Not a candidate for SSS | ||||
| No | 44 (46.3) | 41 (45.6) | 85 (45.9) | >.99 |
| Yes | 51 (53.7) | 49 (54.4) | 100 (54.1) | |
| N stage | ||||
| N0 | 22 (23.2) | 20 (22.2) | 42 (22.7) | >.99 |
| N1 | 36 (37.9) | 35 (38.9) | 71 (38.4) | |
| N2 | 37 (38.9) | 35 (38.9) | 72 (38.9) | |
| T stage | ||||
| T1/T2 | 5 (5.3) | 4 (4.4) | 9 (4.9) | .90 |
| T3 | 68 (71.6) | 67 (74.4) | 135 (73.0) | |
| T4 | 22 (23.2) | 19 (21.1) | 41 (22.2) | |
Abbreviations: CA, control arm; PA, pembrolizumab arm; SSS, sphincter-sparing surgery.