Table 2.
Baseline demographic and disease characteristics of 133 patients.
| Covariate | SHR-1210-101 | SHR-1210-102 | SHR-1210-103 | SHR-1210-II-204 | Total |
|---|---|---|---|---|---|
| Number of patients | 49 (36.8%) | 36 (27.1%) | 36 (27.1%) | 12 (9.0%) | 133 (100%) |
| Number of PK samples | 1140 (34.6%) | 986 (29.9%) | 1052 (31.9%) | 120 (3.6%) | 3298 (100%) |
| Sex | |||||
| Male | 37 (75.5%) | 17 (47.2%) | 28 (77.8%) | 6 (50%) | 88 (66.2%) |
| Female | 12 (24.5%) | 19 (52.8%) | 8 (22.2%) | 6 (50%) | 45 (33.8%) |
| Race | |||||
| Han | 49 (100%) | 34 (94.4%) | 34 (94.4%) | 11 (91.7%) | 128 (96.2%) |
| Others | 0 (100%) | 2 (5.6%) | 2 (5.6%) | 1 (8.3%) | 5 (3.8%) |
| Age (year) | 47 (23–69) | 52 (29–68) | 54.5 (35–65) | 28.5 (21–50) | 50 (21–69) |
| Weight (kg) | 56.5 (36.8–72.1) | 64 (41–90) | 65.5 (47–91) | 63 (42–86) | 61 (36.8–91) |
| Lean body weight (kg) | 46.1 (30.2–57.3) | 45.7 (33.5–63.7) | 49.32 (39.6–67.1) | 43.87 (33.8–65.1) | 46.62 (30.2–67.1) |
| Red blood cell (1012/L) | 4.2 (2.7–5.7) | 4.3 (3.3–5.4) | 4.1 (2.7–5.9) | 4.3 (3.4–5.6) | 4.2 (2.7–5.9) |
| White blood cells (109/L) | 6.9 (3.4–15.7) | 5.9 (2.8–12.4) | 6.3 (3.25–11.0) | 7.7 (1.7–14.4) | 6.3 (1.7–15.7) |
| Platelet (109/L) | 243 (100–548) | 217 (116–580) | 194 (130–447) | 232 (106–380) | 222 (100–580) |
| Albumin (g/L) | 43.2 (29.7–50.4) | 45.3 (32.7–52.5) | 44.1 (38.2–50.2) | 41.7 (35.3–48.1) | 44 (29.7–52.5) |
| Aspartate aminotransferase (U/L) | 15.4 (6.4–72.8) | 23.5 (13–82) | 21 (12–49) | 19 (13–38) | 21.7 (8–115.4) |
| Alanine aminotransferase (U/L) | 22.9 (8–115.4) | 16 (5–88) | 15 (7–55) | 13 (5–54) | 15 (5–88) |
| Total bilirubin (μmol/L) | 8.3 (5.1–20.6) | 11.45 (5.9–24.1) | 9.8 (4.9–22.3) | 11.25 (8.4–24.2) | 9.7 (4.9–24.2) |
| Creatinine clearance (mL/min) | 89.1 (51.5–159.0) | 108.33 (52.8–178.7) | 101.1 (61.3–160.9) | 136.9 (110.7–210.8) | 100.7 (51.5–210.8) |
| Activated partial thromboplastin time (s) | 27.7 (18.9–40.1) | 30.2 (24.7–60.5) | 27.8 (21.4–36.5) | 37.2 (30.2–50.4) | 29.1 (18.9–60.5) |
| Anti-drug antibody | |||||
| Positive | 7 (14.2%) | 6 (16.7%) | 5 (13.9%) | / | 18 (13.5%) |
| Negative | 42 (85.8%) | 30 (83.3%) | 31 (86.1%) | / | 103 (77.4%) |
| Unknown | / | / | / | 12 (100%) | 12 (9.1%) |
| Tumor | |||||
| Nasopharyngeal carcinoma | 31 (63.3%) | / | 3 (8.3%) | / | 34 (25.6%) |
| Lung cancer | 18 (36.7%) | / | 3 (8.3%) | / | 21 (15.8%) |
| Melanoma | / | 36 (100%) | / | / | 36 (27.1%) |
| Esophageal cancer | / | / | 14 (38.9%) | / | 14 (10.1%) |
| Gastric cancer | / | / | 5 (13.9%) | / | 5 (3.8%) |
| Classical Hodgkin lymphoma | / | / | / | 12 (100%) | 12 (9.0%) |
| Others | / | / | 11 (30.6%) | / | 11 (8.2%) |
| Co-administration | |||||
| Combination therapy | 48 (98.0%) | 33 (91.7%) | 36 (100%) | 12 (100%) | 129 (97.0%) |
| Monotherapy | 1 (2%) | 3 (8.3%) | / | / | 4 (3%) |