Nivolumab and TACE (n=31) | Nivolumab only (n=93) OS-matched | P value | Nivolumab only (n=62) PFS-matched | P value | |
Age (SD) | 65.0 (13.8) | 64.8 (10.4) | 0.08 | 66.4 (10.6) | 0.56 |
Female (%) | 4 (13) | 19 (20) | 0.35 | 14 (16) | 0.68 |
Liver disease* | |||||
HBV (%) | 9 (29) | 36 (39) | 0.39 | 26 (27) | >0.99 |
HCV (%) | 9 (29) | 31 (33) | 0.83 | 21 (34) | 0.81 |
EtOH (%) | 6 (19) | 16 (17) | 0.79 | 17 (27) | 0.45 |
NASH (%) | 5 (16) | 11 (12) | 0.54 | 9 (15) | >0.99 |
Other (%) | 3 (9.7) | 1 (1.1) | 0.048* | 0 (0) | 0.003* |
Child-Pugh | 0.92 | 0.10 | |||
A | 25 (81) | 76 (82) | 39 (61) | ||
B | 5 (16) | 15 (16) | 20 (34) | ||
C | 1 (3.2) | 2 (2.0) | 3 (4.8) | ||
PS ECOG | 0.19 | 0.18 | |||
0–1 | 31 (100) | 85 (91) | 62 (93) | ||
>1 | 0 | 8 (8.6) | 5 (7.5) | ||
BCLC | 0.05 | 0.006* | |||
A | 2 (6.4) | 12 (13) | 11 (18) | ||
B | 10 (32) | 43 (46) | 32 (52) | ||
C | 18 (58) | 36 (39) | 17 (27) | ||
D | 1 (3.2) | 2 (2) | 2 (3) | ||
AFP >400 (%) | 5 (16) | 16 (17) | >0.99 | 10 (16) | >0.99 |
ALBI grade† | 1.7 (0.6) | 2.6 (0.9) | <0.001 | 2.2 (0.9) | 0.008 |
PVT | 3 (9.7) | 8 (8.6) | >0.99 | 6 (9.7) | >0.99 |
Metastases | 8 (26) | 24 (26) | >0.99 | 16 (26) | >0.99 |
Max tumor diameter, median (IQR) | 2.8 (1.7–6.2) | 4.2 (2.2–7.8) | 0.25 | 4.2 (2.4–7.5) | 0.24 |
Median number of Nodules (IQR) | 3 (2–3) | 2 (1–4) | 0.26 | 1 (1–4) | 0.04* |
Milan criteria | 8 (26) | 25 (27) | >0.99 | 21 (34) | 0.48 |
Prior treatments | |||||
Surgery | 13 (42) | 31 (33) | 0.40 | 19 (31) | 0.36 |
Ablation | 4 (13) | 29 (31) | 0.06 | 23 (37) | 0.017* |
TACE | 12 (39) | 52 (56) | 0.10 | 38 (62) | 0.04 |
TARE | 1 (3.2) | 18 (19) | 0.04* | 12 (19) | 0.05 |
Sorafenib | 3 (9.7) | 57 (61) | <0.0001* | 32 (52) | <0.0001* |
RT | 1 (3.2) | 12 (13) | 0.18 | 7 (11) | 0.26 |
*Patients in combined treatment and matched groups could have multiple liver disease etiologies.
†ALBI scores were missing in 20% of the monotherapy cohort.
AFP, alpha fetoprotein; ALBI, albumin–bilirubin; BCLC, Barcelona Clinic Liver Classification; ECOG-PS, Eastern Cooperative Oncology Group Performance Status; EtOH, alcoholic cirrhosis; HBC, hepatitis C virus; HBV, hepatitis B virus; NASH, non-alcoholic steatohepatitis; OS, overall survival; PFS, progression-free survival; PVT, portal vein thrombosis; RT, radiation therapy; TACE, transarterial chemoembolization; TARE, transarterial radioembolization.