Table 1.
Baseline characteristics of the 45 AMC patients
| Baseline characteristics | Total (n = 45), % | Nivolumab (n = 28), % | Placebo (n = 17), % |
|---|---|---|---|
| Age (median, range) | 60 (23–76) | 60 (23–76) | 59 (33–74) |
| Sex (Male) | 34 (75.6) | 21 (75.0) | 13 (76.5) |
| Metastatic organs | |||
| Liver | 13 (29.5) | 10 (35.7) | 3 (18.8) |
| Peritoneum | 14 (31.8) | 8 (28.6) | 6 (37.5) |
| Lymph node | 27 (60.0) | 17 (60.7) | 10 (58.8) |
| Others | 7 (15.9) | 5 (17.8) | 2 (12.5) |
| Number of metastatic organs ≥ 2 | 19 (42.2) | 13 (46.4) | 6 (35.3) |
| Prior gastrectomy | 26 (57.8) | 14 (50.0) | 12 (70.6) |
| HER2 positive | 10 (22.2) | 6 (21.4) | 4 (23.5) |
| Treatment line | |||
| 3rd line | 24 (53.3) | 13 (46.4) | 11 (64.7) |
| ≥ 4th line | 21 (46.7) | 15 (56.6) | 6 (35.3) |
| Baseline blood NLR ≤ 2.9 | 23 (51.1) | 13 (46.4) | 10 (58.8) |
| Baseline serum Na ≥ 135 mmol/L | 38 (84.4) | 24 (85.7) | 14 (82.4) |
| Tissue analysis | Total (n = 36), % | Nivolumab (n = 22), % | Placebo (n = 14), % |
| PD-L1 | |||
| CPS < 1% | 23 (63.9) | 14 (63.6) | 9 (64.3) |
| CPS ≥ 1% | 13 (36.1) | 8 (36.4) | 5 (35.7) |
| CPS ≥ 10% | 4 (11.2) | 2 (9.1) | 2 (14.3) |
| MSI-high | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| EBV-positive | 6 (16.7) | 5 (22.7) | 1 (7.1) |
| Next-generation sequencing analysis | Total (n = 29), % | Nivolumab (n = 15), % | Placebo (n = 14), % |
| TMB (/Mb) | 8.2 (0.0–21.3) | 9.8 (0.0–21.3) | 8.2 (1.6–16.4) |
AMC Asan Medical Center, NLR Neutrophil–lymphocyte ratio, MSI Microsatellite instability, EBV Epstein-Barr Virus, TMB Tumor mutation burden