Table 1.
Baseline characteristics of patients who received sintilimab or placebo in combination with chemotherapy
| Sintilimab and chemotherapy (n=327) | Placebo and chemotherapy (n=332) | |
|---|---|---|
| Age (years): | ||
| Median (IQR) | 63 (57-67) | 63 (56-67) |
| <65 | 189 (58) | 202 (61) |
| ≥65 | 138 (42) | 130 (39) |
| Sex: | ||
| Men | 279 (85) | 288 (87) |
| Women | 48 (15) | 44 (13) |
| Race: | ||
| Asian | 320 (98) | 321 (97) |
| White | 4 (1) | 8 (2) |
| Not reported | 3 (1) | 3 (1) |
| Country: | ||
| China | 319 (98) | 321 (97) |
| Outside China | 8 (2) | 11 (3) |
| Weight (kg): | ||
| <60 | 191 (58) | 183 (55) |
| ≥60 | 136 (42) | 149 (45) |
| ECOG performance status: | ||
| 0 | 77 (24) | 81 (24) |
| 1 | 250 (76) | 251 (76) |
| Disease status at enrolment: | ||
| Metastatic | 285 (87) | 287 (86) |
| Local advanced | 42 (13) | 45 (14) |
| Site of metastases: | ||
| Liver | 78 (24) | 81 (24) |
| Lung | 110 (34) | 110 (33) |
| Bone | 39 (12) | 45 (14) |
| Lymph node | 309 (95) | 302 (91) |
| Chemotherapy regimen: | ||
| Cisplatin plus paclitaxel | 307 (94) | 309 (93) |
| Cisplatin plus 5-fluorouracil | 20 (6) | 23 (7) |
| PD-L1 expression (CPS): | ||
| CPS <1 | 32 (10) | 23 (7) |
| CPS ≥1 | 295 (90) | 309 (93) |
| CPS <5 | 89 (27) | 79 (24) |
| CPS ≥5 | 238 (73) | 253 (76) |
| CPS <10 | 139 (43) | 139 (42) |
| CPS ≥10 | 188 (57) | 193 (58) |
| PD-L1 expression (TPS): | ||
| TPS <1% | 153 (47) | 144 (43) |
| TPS ≥1% | 174 (53) | 188 (57) |
| TPS <5% | 189 (58) | 182 (55) |
| TPS ≥5% | 138 (42) | 150 (45) |
| TPS <10% | 208 (64) | 213 (64) |
| TPS ≥10% | 119 (36) | 119 (36) |
| Previous treatment: | ||
| Surgery | 96 (29) | 113 (34) |
| Radiotherapy | 56 (17) | 70 (21) |
Data are number (%) unless indicated otherwise. Percentages might not sum to 100 because of rounding. IQR=interquartile range; ECOG=Eastern Cooperative Oncology Group; PD-L1, programmed cell death ligand 1; TPS=tumour proportion score; CPS=combined positive score.