Table 1.
Patient demographics, baseline characteristics, and therapeutic response
| Character (N = 87) | n (%) or median (IQR) |
|---|---|
| Age (years) | 63.4 (55.4-68.6) |
| Sex (male), n (%) | 79 (90.8) |
| Body mass index (kg/m2) | 23.26 (20.69-26.30) |
| NLR | 5.53 (3.26-10.23) |
| Platelet count (109/L) | 153 (95-231) |
| AST (U/L) | 70 (43-120) |
| ALT (U/L) | 51 (29-69) |
| Total bilirubin (mg/dL) | 1.3 (0.8-2.0) |
| Albumin (g/dL) | 3.5 (3.0-4.0) |
| INR | 1.12 (1.04-1.24) |
| Etiology | |
| Alcohol | 23 (26.4) |
| HBV | 51 (58.6) |
| HCV | 22 (25.3) |
| Diabetes mellitus | 25 (28.7) |
| Liver cirrhosis | 67 (77.0) |
| Child-Pugh score | 6 (5-8) |
| Class A/B/C | 45 (51.7)/30 (34.5)/10 (11.5) |
| ALBI grade 1/2/3 | 20 (23.8)/47 (56.0)/17 (20.2) |
| AFP (ng/mL) | 296.92 (15.36-7282.00) |
| AFP ≥400 ng/mL | 39 (44.8) |
| BCLC stage A/B/C/D | 7 (8.0)/9 (10.3)/60 (69.0)/11 (12.6) |
| CLIP score | 2 (1-4) |
| Max. tumor size (cm) | 5.2 (2.7-8.3) |
| Tumor number | |
| 1/2/3/≥4 | 20 (23.0)/8 (9.2)/9 (10.3)/50 (57.5) |
| Total tumor volume (cm3) | 1032 (245-3844) |
| MVIa | 51 (58.6) |
| VP3/VP4/hepatic vein | 18 (20.7)/31 (35.6)/2 (2.3) |
| EHMa | 52 (59.8) |
| Prior therapy | |
| Sorafenib | 43 (49.4) |
| Lenvatinib | 7 (8.0) |
| TACEc/TARE | 49 (56.3)/2 (2.3) |
| Radiotherapy | 44 (50.6) |
| Surgery | 16 (18.4) |
| RFA | 15 (17.2) |
| PEI | 4 (4.6) |
| Injection numbers of nivolumab/duration (months) | 6 (3-8)/2.53 (1.47-4.23) |
| Reduction >25% | 17 (19.5) |
| As 1st/2nd/3rd/4th-line systemic therapy | 14 (16.1)/55 (63.2)/12 (13.8)/6 (6.9) |
| Concurrent therapy | 56 (64.4) |
| Sorafenibb | 24 (27.6) |
| Regorafenibb | 5 (5.7) |
| Lenvatinibb | 19 (21.8) |
| Chemotherapy | 7 (8.0) |
| Radiotherapy | 13 (14.9) |
| TACE | 11 (12.6) |
| Therapeutic response | |
| Best Response | |
| Complete response | 9 (10.3) |
| Partial response | 8 (9.2) |
| Stable disease | 17 (19.5) |
| Progressive disease | 28 (32.2) |
| Not evaluable | |
| Death before evaluation | 20 (23.0) |
| Lost to follow-upd | 5 (5.7) |
| Objective response | 17 (19.5) |
| Disease control | 34 (39.1) |
| Progression-free survival (months) | 2.67 (1.87-6.90) |
| Overall survival (months) | 5.87 (2.43-15.93) |
Data presented as the median (first quartile-third quartile). AFP, α-fetoprotein; ALBI, albumin-bilirubin; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BCLC, Barcelona Clinic Liver Cancer; EHM, extrahepatic metastasis; CLIP, Cancer of the Liver Italian Program; HBV, hepatitis B virus; HCV, hepatitis C virus; IQR, interquartile range; MVI, macrovascular invasion; NLR, neutrophil-lymphocyte ratio; TACE, transarterial chemoembolization; TARE, transarterial radioembolization; TKI, tyrosine kinase inhibitor; PEI, percutaneous ethanol injection; INR, international normalized ratio; RFA, radiofrequency ablation.
In total, 32 HCC patients had both macrovascular invasion and extrahepatic metastasis.
A total of 7 patients received sequential TKI therapy because of progressive disease: sorafenib→regorafenib (3), sorafenib→lenvatinib (3), and sorafenib→lenvatinib→regorafenib (1).
The median number of TACE sessions was 4 (2-6).
In total, 5 patients were lost to follow-up because of immune-related adverse events (n = 3), for economic reasons (n = 1), and because of rapidly deteriorated bone pain (n = 1).