Table 1.
Patient and tumor characteristics
| Characteristics | Study arm | |||
|---|---|---|---|---|
| Nivolumab (n = 210) | Chemotherapy control | |||
| Chemotherapy pooled (n = 209) | Docetaxel (n = 65) | Paclitaxel (n = 144) | ||
| Sex | ||||
| Male | 179 (85) | 185 (89) | 56 (86) | 129 (90) |
| Age, years | ||||
| Mean (SD) | 62.8 (8.9) | 64.9 (9.3) | 65.5 (8.6) | 64.6 (9.7) |
| Median (min, max) | 64.0 (37, 82) | 67.0 (33, 87) | 67.0 (48, 81) | 67.0 (33, 87) |
| Age group, years | ||||
| ≥65 | 98 (47) | 124 (59) | 44 (68) | 80 (56) |
| ≥75 | 14 (7) | 28 (13) | 7 (11) | 21 (15) |
| Race | ||||
| White | 9 (4) | 9 (4) | 4 (6) | 5 (3.5) |
| Asian | 201 (96) | 200 (96) | 61 (94) | 139 (96.5) |
| Geographic region a | ||||
| Japan | 136 (65) | 138 (66) | 44 (68) | 94 (65) |
| Rest of World | 74 (35) | 71 (34) | 21 (32) | 50 (35) |
| ECOG status | ||||
| 0 | 101 (48) | 107 (51) | 38 (58.5) | 69 (48) |
| 1 | 109 (52) | 102 (49) | 27 (41.5) | 75 (52) |
| Lesion site | ||||
| Cervical esophagus | 5 (2) | 7 (3) | 3 (5) | 4 (3) |
| Thoracic esophagus | 84 (40) | 93 (45) | 30 (46) | 63 (44) |
| Cervical and thoracic esophagus | 3 (1) | 7 (3) | 1 (2) | 6 (4) |
| Unknown | 118 (56) | 102 (49) | 31 (48) | 71 (49) |
| Recurrent | ||||
| Yes | 103 (49) | 89 (43) | 31 (48) | 58 (40) |
| Disease stage (TNM) | ||||
| I–III | 11 (5) | 18 (9) | 7 (11) | 11 (7.6) |
| IV | 172 (82) | 168 (80) | 49 (75) | 119 (82.6) |
| Unknown | 27 (13) | 23 (11) | 9 (14) | 14 (9.7) |
| Number of organs with metastases a | ||||
| ≤1 | 89 (42) | 91 (43.5) | 30 (46) | 61 (42) |
| ≥2 | 121 (58) | 118 (56.5) | 35 (54) | 83 (58) |
| PD‐L1 expression a | ||||
| <1% | 109 (52) | 107 (51) | 30 (46) | 77 (54) |
| ≥1% | 101 (48) | 102 (49) | 35 (54) | 67 (47) |
| <5% | 136 (65) | 137 (66) | 41 (63) | 96 (67) |
| ≥5% | 74 (35) | 72 (34) | 24 (37) | 48 (33) |
| <10% | 146 (69.5) | 152 (73) | 47 (72) | 105 (73) |
| ≥10% | 64 (30.5) | 57 (27) | 18 (28) | 39 (27) |
Data are shown as n (%) unless otherwise noted.
a
Stratification factor for randomization.
Abbreviations: ECOG, Eastern Cooperative Oncology Group; PD‐L1, Programmed death‐ligand 1; TNM, tumor, node, metastasis staging system.