Real-life multi-center retrospective analysis on nivolumab in difficult-to-treat patients with advanced hepatocellular carcinoma

Table 1 patient characteristics

Characteristic	Case subjects (n = 29)
Sex
Male (n)	21
Female (n)	8
Age at diagnosis, yr (mean ± SEM)	69.1 ± 2.1
BMI, kg/m² (mean ± SEM)	26.6 ± 1.0
BCLC stage (n)
BCLB-B	1
BCLB-C	28
HCC characteristics (n)
Bilobar	18/28
Multifocal	15/26
Vascular invasion	8/29
UP-TO-7-Criteria	16/29
Metastasis (n)
No metastases	16
1 meta location	8
2 meta locations	3
4 meta locations	2
AFP at baseline, ng/mL (mean ± SEM)	4375.6 ± 2566.6
Cirrhosis (n)
No Cirrhosis	10
CP A	10
CP B	8
Unknown	1
Origin cirrhosis (n)
HBV	4
HCV	2
Ethyl	7
NAFLD	3
Other	2
Missing	1
WHO performance status (n)
0	5
1	21
2	3
Previous treatment (n) (Resection, radiofrequency ablation, transarterial radioembolization, transarterial chemoembolization, selective internal radiation therapy, sorafenib, capecitabine, GEMOX, doxorubicine, FOLFOX, regorafenib, cabozantinib)
Yes	27
No	2

WHO: World Health Organization; CP: Child-Pugh; BMI: Body mass index; BCLC: Barcelona clinic liver cancer; HCC: Hepatocellular cancer; AFP: Alpha-fetoprotein; HBV: Hepatitis B virus; HCV: Hepatitis C virus; NAFLD: Nonalcoholic fatty liver disease.

Table 2 Survival per radiologic response category

Radiological response	Total n	Overall survival, mo (mean ± SEM)	n of deaths (%)	n alive at study closure (%)
Progressive disease	16	8.8 ± 2.0	15 (93.7)	1 (6.3)
Stable disease	6	10.4 ± 2.1	5 (83.3)	1 (16.7)
Partial response	3	Not assessable	2 (66.7)	1 (33.3)
Complete response	4	Not assessable	0 (0)	4 (100)
Overall	29	14.5 ± 2.1	22 (75.9)	7 (24.1)

Not assessable: Patients were alive at study closure.

Table 3 Survival per biological response category

Biological (AFP) response	Total n	Overall survival, mo (mean ± SEM)	n of deaths (%)	n alive at study closure (%)
Increase ≥ 25%	16	9.6 ± 1.8	15 (93.7)	1 (6.3)
Stable	2	2	2 (100)	0 (0)
Decrease ≥ 25% without normalization	1	26	1 (100)	0 (0)
Normalization of AFP (< 7 μg/L)	5	Not assessable	0 (0)	5 (100)
AFP remains negative	5	13.8 ± 3.9	4 (80)	1 (20)
Overall	29	14.5 ± 2.1	22 (75.9)	7 (24.1)

Not assessable: Patients were alive at study closure. AFP: Alpha-fetoprotein.

Table 4 Evolution of World Health Organization performance status

WHO PS	2 mo	4 mo
Worse PS	8 (29.6%)	5 (21.7%)
Stable PS	14 (51.9%)	13 (56.5%)
Better PS	5 (18.5%)	5 (21.7%)
Total	27 (100%)	23 (100%)
Death	2	6

WHO PS: World Health Organization performance status.

Table 5 Evolution of Child-Pugh score

CP score	2 mo	4 mo
Worse CP	9 (36%)	7 (33.3%)
Stable CP	15 (60%)	12 (57.1%)
Better CP	1 (4%)	2 (9.5%)
Total	25 (100%)	21 (100%)
Death	2	6
Missing	2	2

CP: Child-Pugh score.

Table 6 Viral vs non-viral liver disease and response to nivolumab

Radiological response	Non-viral liver disease	Viral disease	Total
Progressive disease	10	5	15
Stable disease	5	1	6
Partial response	3	0	3
Complete response	4	0	4
Total	22	6	28

The numbers represent the patient count.