Table 1.
Characteristics of the Patients at Baseline.*
| Characteristic | dMMR Cohort | pMMR Cohort | ||||||
|---|---|---|---|---|---|---|---|---|
| Pembrolizumab (N = 112) |
Placebo (N = 113) |
All Patients (N = 225) |
Pembrolizumab (N = 293) |
Placebo (N = 295) |
All Patients (N = 588) |
|||
| Demographic | ||||||||
| Median age (range) — yr | 67 (38–81) | 66 (37–85) | 66 (37–85) | 66 (31–93) | 65 (29–90) | 65.5 (29–93) | ||
| Race or ethnic group — no. (%)† | ||||||||
| White | 92 (82.1) | 86 (76.1) | 178 (79.1) | 212 (72.4) | 212 (71.9) | 424 (72.1) | ||
| Black | 11 (9.8) | 9 (8.0) | 20 (8.9) | 45 (15.4) | 51 (17.3) | 96 (16.3) | ||
| Asian | 3 (2.7) | 4 (3.5) | 7 (3.1) | 17 (5.8) | 14 (4.7) | 31 (5.3) | ||
| American Indian or Alaska Native | 0 | 2 (1.8) | 2 (0.9) | 2 (0.7) | 2 (0.7) | 4 (0.7) | ||
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 1 (0.3) | 3 (1.0) | 4 (0.7) | ||
| Unknown | 3 (2.7) | 9 (8.0) | 12 (5.3) | 8 (2.7) | 7 (2.4) | 15 (2.6) | ||
| Not reported | 3 (2.7) | 3 (2.7) | 6 (2.7) | 7 (2.4) | 5 (1.7) | 12 (2.0) | ||
| Multiracial | 0 | 0 | 0 | 1 (0.3) | 1 (0.3) | 2 (0.3) | ||
| Hispanic ethnic group — no. (%)† | ||||||||
| No | 106 (94.6) | 99 (87.6) | 205 (91.1) | 263 (89.8) | 273 (92.5) | 536 (91.2) | ||
| Yes | 5 (4.5) | 6 (5.3) | 11 (4.9) | 21 (7.2) | 16 (5.4) | 37 (6.3) | ||
| Unknown | 1 (0.9) | 4 (3.5) | 5 (2.2) | 4 (1.4) | 3 (1.0) | 7 (1.2) | ||
| Not reported | 0 | 4 (3.5) | 4 (1.8) | 5 (1.7) | 3 (1.0) | 8 (1.4) | ||
| Medical history | ||||||||
| ECOG performance-status score — no. (%)‡ | ||||||||
| 0 | 72 (64.3) | 73 (64.6) | 145 (64.4) | 196 (66.9) | 198 (67.1) | 394 (67.0) | ||
| 1 | 39 (34.8) | 35 (31.0) | 74 (32.9) | 88 (30.0) | 88 (29.8) | 176 (29.9) | ||
| 2 | 1 (0.9) | 5 (4.4) | 6 (2.7) | 9 (3.1) | 9 (3.1) | 18 (3.1) | ||
| Histologic analysis - no. (%) | ||||||||
| Adenocarcinoma, NOS§ | 12 (10.7) | 14 (12.4) | 26 (11.6) | 24 (8.2) | 33 (11.2) | 57 (9.7) | ||
| Clear cell | 1 (0.9) | 0 | 1 (0.4) | 17 (5.8) | 20 (6.8) | 37 (6.3) | ||
| Dedifferentiated or undifferentiated | 4 (3.6) | 4 (3.5) | 8 (3.6) | 7 (2.4) | 6 (2.0) | 13 (2.2) | ||
| Endometrioid | ||||||||
| G1 | 21 (18.8) | 35 (31.0) | 56 (24.9) | 54 (18.4) | 46 (15.6) | 100 (17.0) | ||
| G2 | 52 (46.4) | 41 (36.3) | 93 (41.3) | 51 (17.4) | 58 (19.7) | 109 (18.5) | ||
| G3 | 15 (13.4) | 16 (14.2) | 31 (13.8) | 53 (18.1) | 42 (14.2) | 95 (16.2) | ||
| Mixed epithelial | 3 (2.7) | 2 (1.8) | 5 (2.2) | 6 (2.0) | 11 (3.7) | 17 (2.9) | ||
| Serous | 4 (3.6) | 1 (0.9) | 5 (2.2) | 78 (26.6) | 72 (24.4) | 150 (25.5) | ||
| Pending | 0 | 0 | 0 | 3 (1.0) | 7 (2.4) | 10 (1.7) | ||
| Previous therapy | ||||||||
| Chemotherapy - no. (%) | ||||||||
| Yes | 5 (4.5) | 8 (7.1) | 13 (5.8) | 72 (24.6) | 77 (26.1) | 149 (25.3) | ||
| No | 107 (95.5) | 105 (92.9) | 212 (94.2) | 221 (75.4) | 218 (73.9) | 439 (74.7) | ||
| Radiotherapy - no. (%) | ||||||||
| Yes | 41 (36.6) | 55 (48.7) | 96 (42.7) | 114 (38.9) | 119 (40.3) | 233 (39.6) | ||
| No | 71 (63.4) | 58 (51.3) | 129 (57.3) | 179 (61.1) | 176 (59.7) | 355 (60.4) | ||
| Surgery - no. (%) | ||||||||
| Yes | 98 (87.5) | 105 (92.9) | 203 (90.2) | 261 (89.1) | 245 (83.1) | 506 (86.1) | ||
| No | 14 (12.5) | 8 (7.1) | 22 (9.8) | 29 (9.9) | 46 (15.6) | 75 (12.8) | ||
| Missing data | 0 | 0 | 0 | 3 (1.0) | 4 (1.4) | 7 (1.2) | ||
*
Patients who were assigned to receive pembrolizumab or placebo also received combination therapy with paclitaxel plus carboplatin. Percentages may not total 100 because of rounding. The abbreviation dMMR denotes mismatch repair–deficient, and pMMR mismatch repair–proficient.
†
Race and ethnic group were reported by the patients.
‡
Eastern Cooperative Oncology Group (ECOG) performance-status scores are assessed on a scale of 0 to 5, with higher scores indicating greater disability.
§
The “not otherwise specified” (NOS) category included endometrioid adenocarcinoma, grade not specified.