Survival of patients with hepatocellular carcinoma treated with immunotherapy experience of a third level center.

Introduction and Objectives

Hepatocellular carcinoma (HCC) ranks sixth among tumors, the third cause of death worldwide and accounts for 85-90% of primary liver tumors. Recently, the use of immunotherapy as first-line treatment offers a survival of 18 months. The objective of this study is to assess the survival and adverse effects of the different immune checkpoint inhibitor therapies in our population

Materials and Patients

Patients who received immunotherapy at the Central Military Hospital from January 2021 to April 2023 were included. The following were recorded: leukocytes, hemoglobin, platelets, PT, INR, BT, AST, ALT, ALP, albumin, MELD, MELD-Na, ALBI, MELD 3.0 before and after treatment, calculation of survival, progression-free time and adverse effects

Results

18 patients with stage A were included 2 patients, BCLC B 6 patients and BCLC C 10 patients, age 67.72 ± 14.40 years, 11 (61%) men, the following immunotherapy schemes were given: atezolizumab + bevacizumab 13 patients and 5 patients with Nivolumab. The following variables were compared before and after immunotherapy: leukocytes, hemoglobin, platelets, PT, INR, BT, AST, ALT, ALP, albumin, MELD, MELD-Na, ALBI, MELD 3.0. Without finding statistical differences (Table 1). Adverse effects were 1 patient presented with clostridiode and 2 with immune-mediated hepatitis without improvement after treatment, which required suspension of immunotherapy and initiation of second line treatment. Overall survival was 19 months and progression-free time 15 months.

Conclusions

The overall survival of the patients was 19 months, the adverse effects that the patients appeared were similar to those reported in the literature.

Ethical statement

The protocol was registered and approved by the Ethics Committee. The identity of the patients is protected. Consentment was obtained.

Declaration of interests

None

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Table 1.

Blood chemistry, complete blood count and liver function tests in patients with Ca undergoing treatment before and after immunotherapy (n=18).

	Patients before immunotherapy (n= 18)	Patient after immunotherapy (n=18)
Pattern (units)	Values (media ± DE)	Values (media ± DE)	^tt (gl)	P<0.05	IC 95%	Reference ranges
Age	67.72 ± 14.40	69.63 ± 14.05	-3.15 (17)	0.006	-3.1 – -0.6	(años)
Gender
• Man	11	11				n=11
• Woman	7	7				n=7
CHILD PUG	6-56± 1.33	6,72± 1.74	-0.54 (17)	0.59	-0.81 – 0.47
MELD	9.11± 2.11	10.39± 5.34	-1.11(17)	0.28	-3.69– 1.13
MELD NA	9.17± 2.22	10.89± 6.07	-1.36 (17)	0.18	-4.38 – 0.93
MELD 3.0	10.56± 2.79	12.06± 5.62	-1.11 (17)	0.28	-4.34– 1.34
ALBI	-1.95± 0.81	-1.91± 0.68	-0.14 (17)	0.88	-0.56– -0.49
Leukocytes x103/µL	6.15± 2.94	5.57± 2.45	0.87 (17)	0.39	-0.80– 1.95	5 - 10
Hemoglobin g/dL	13.02 ± 2.67	13.02 ±2.77	0.00 (17)	1.00	-1.36 – 1.36	13.5 – 18
Platelet x10^9/µL	265.59± 80.79***	169.00 ± 80.80***	1.54 (16)	0.14	-36.24– 229.41	150 – 450
PT (seconds)	12.95 ± 4.11	11.41 ± 3.63	1.13 (17)	0.27	-1.32– 4.40	11.0 – 13.5
INR	1.94± 3.34***	1.14 ± 0.22***	1.01 (17)	0.32	-0.87 – 2.48	≤1
Total Bilirrubin (mg/dL)	1.27± 0.63***	1.58± 1.26***	-1.24 (17)	0.22	-0.82 – 0.21	0.2 – 1.2
Direct Bilirrubin (mg/dL)	0.44 ± 0.43***	0.57 ± 0.69***	-0.83 (17)	0.41	-0.45– 0.19	0 - 0.2
No Direct Bilirrubin (mg/dL)	0.83± 0.52***	1.01± 0.77***	-1.36 (17)	0.19	-0.46 – 0.10	0 - 0.8
ALT (TGP) (UI/L)	82.11± 128.12***	48.56± 42.60***	1.07 (17)	0.30	-32.63–99.74	10 - 35
AST (TGO) (UI/L)	88.55 ± 86.06***	78.22± 55.96***	-0.42(17)	0.67	-41.15– 61.81	5 - 34
ALP (Alkaline phosphatose) UI/L	250.72 ± 205.12***	307.22 ± 179.99***	-1.56(17)	0.13	-132.50 – 19.50	<138
Albúmin g/dL	3.39± 0.66	3.28± 0.77	0.60 (17)	0.55	-0.27 – 0.49	3.5 - 4.8
Alpha-fetoprotein (nanograms)	6455.04± 21565.83***	2570.74± 5706.40***	0.63 (13)	0.53	-9346.56 – 17115.18	<300 nanograms

***Out of clinical reference value // t-test for related samples pre-post, *P<0.05 // AST- Aspartate aminotransferase, ALT- Alanine aminotransferase, ALP- alkaline phosphatase, GGT- Gamma glutamyl transferase. // + OS actual overall survival