表 1.
入组患者的一般基线特征
Demographic and baseline characteristics
Items | Atezolizumab (n=100) | Atezolizumab+gemcitabine+cisplatin (n=20) |
CRC, colorectal cancer; UC, urothelial cancer; PK, pharmacokinetics; PD-L1, programmed death-ligand 1; EBV, Epstein-Barr virus; MSI-H, microsatellite instability-high; BTC, biliary tract carcinoma; NET, neuroendocrine tumor; ECOG, Eastern Cooperative Oncology Group; IC, immune cells; TC, tumor cells; NA, not applicable. Other abbreviations as in Figure 1. a, PD-L1+ status is defined as IC or TC≥1%; b, PD-L1 IC score at baseline: IC < 1% (IC0), 1% < IC < 5% (IC1), 5% < IC < 10% (IC2), IC≥10% (IC3); c, PD-L1 TC score at baseline: TC < 1% (TC0), 1% < TC < 5% (TC1), 5% < TC < 50% (TC2), TC≥50% (TC3). | ||
Age/years, median (range) | 55.0 (19.0-77.0) | 60.0 (38.0-77.0) |
Age < 65 years, n(%) | 81 (81.0) | 14 (70.0) |
Male, n(%) | 80 (80.0) | 18 (90.0) |
Weight/kg, Median (Range) | 60.0 (33.0-96.0) | 64.5 (47.0-94.0) |
Study cohort | ||
EC (PD-L1+/PD-L1-), n | 20 (10/10) | NA |
GC (PD-L1+/PD-L1-/EBV+/MSI-H), n | 20 (6/14/10/5) | NA |
HCC (PD-L1+/PD-L1-), n | 20 (8/12) | NA |
NPC (PD-L1+/PD-L1-), n | 20 (15/5) | NA |
NSCLC (PD-L1+/PD-L1-), n | NA | 20 (13/7) |
PK (NSCLC/CRC/GC/UC/EC/HCC/BTC/NET),n | 20 (7/4/4/1/1/1/1/1) | NA |
ECOG performance score, n(%) | ||
0 | 21 (21.0) | 0 |
1 | 79 (79.0) | 20 (100.0) |
PD-L1+a, n(%) | 42 (42.0) | 13 (65.0) |
PD-L1 IC scoreb, n(%) | ||
IC0 | 63 (63.0) | 10 (50.0) |
IC1 | 26 (26.0) | 6 (30.0) |
IC2 | 3 (3.0) | 2 (10.0) |
IC3 | 5 (5.0) | 1 (5.0) |
Unknown | 3 (3.0) | 1 (5.0) |
PD-L1 TC scorec, n(%) | ||
TC0 | 81 (81.0) | 13 (65.0) |
TC1 | 5 (5.0) | 1 (5.0) |
TC2 | 10 (10.0) | 1 (5.0) |
TC3 | 1 (1.0) | 4 (20.0) |
Unknown | 3 (3.0) | 1 (5.0) |
Tobacco use, n(%) | ||
Current | 6 (6.0) | 0 |
Previous | 40 (40.0) | 14 (70.0) |
Never | 54 (54.0) | 6 (30.0) |
Alcohol use, n(%) | ||
Current | 5 (5.0) | 0 |
Previous | 32 (32.0) | 11 (55.0) |
Never | 63 (63.0) | 9 (45.0) |
Prior radiotherapy, n(%) | 43 (43.0) | 4 (20.0) |
MSI-H (all cancer types), n(%) | 9 (9.0) | 0 |
Prior therapy for recurrent/metastatic disease, n(%) | 91 (91.0) | 1 (5.0) |