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©The Author(s) 2024.
World J Gastrointest Oncol. Jun 15, 2024; 16(6): 2504-2519
Published online Jun 15, 2024. doi: 10.4251/wjgo.v16.i6.2504
Published online Jun 15, 2024. doi: 10.4251/wjgo.v16.i6.2504
Table 1 Baseline characteristics of the hepatitis B virus-DNA > 2000 and hepatitis B virus-DNA ≤ 2000 groups, n (%)
Variable | Group | P value | |
HBV-DNA > 2000, n = 54 | HBV-DNA ≤ 2000, n = 66 | ||
HBV | 0.614 | ||
Negative | 37 (69) | 48 (73) | |
Positive | 17 (31) | 18 (27) | |
Antiviral therapy | 0.068 | ||
No | 8 (15) | 19 (29) | |
Yes | 46 (85) | 47 (71) | |
Child Pugh score | 0.724 | ||
A | 22 (41) | 29 (44) | |
B | 32 (59) | 37 (56) | |
IVPTT | 0.595 | ||
No | 26 (48) | 35 (53) | |
Yes | 28 (52) | 31 (47) | |
BCLC stage | 0.776 | ||
B | 21 (39) | 24 (36) | |
C | 33 (61) | 42 (64) | |
Metastasis | 0.632 | ||
No | 31 (57) | 35 (53) | |
Yes | 23 (43) | 31 (47) | |
AFP | 0.271 | ||
> 1210 | 24 (44) | 36 (55) | |
≤ 1210 | 30 (56) | 30 (45) | |
Sex | 0.925 | ||
Female | 20 (37) | 25 (38) | |
Male | 34 (63) | 41 (62) | |
Age | 0.811 | ||
< 60 | 29 (54) | 34 (52) | |
≥ 60 | 25 (46) | 32 (48) | |
BMI | 0.413 | ||
Low | 36 (67) | 37 (56) | |
Normal | 2 (4) | 6 (9) | |
Obese | 1 (2) | 4 (6) | |
Overweight | 15 (28) | 19 (29) | |
ECOG | 0.271 | ||
0-1 | 29 (54) | 42 (64) | |
2 | 25 (46) | 24 (36) | |
Post operative | 0.549 | ||
No | 34 (63) | 38 (58) | |
Yes | 20 (37) | 28 (42) | |
ALT | 0.083 | ||
> 40 | 29 (54) | 25 (38) | |
≤ 40 | 25 (46) | 41 (62) | |
Total bilirubin | 0.969 | ||
> 34 | 37 (69) | 45 (68) | |
≤ 34 | 17 (31) | 21 (32) | |
Diabetes | 0.832 | ||
No | 41 (76) | 49 (74) | |
Yes | 13 (24) | 17 (26) | |
Hypertensive | 0.920 | ||
No | 16 (30) | 19 (29) | |
Yes | 38 (70) | 47 (71) | |
Cirrhosis | 0.753 | ||
No | 31 (57) | 36 (55) | |
Yes | 23 (43) | 30 (45) | |
Smoking | 0.889 | ||
No | 37 (69) | 46 (70) | |
Yes | 17 (31) | 20 (30) | |
Alcohol | 0.893 | ||
No | 35 (65) | 42 (64) | |
Yes | 19 (35) | 24 (36) | |
Virus reactivation | 1.000 | ||
No | 53 (98) | 65 (98) | |
Yes | 1 (1.9) | 1 (1.5) |
Table 2 Tumor response between the hepatitis B virus-DNA ≤ 2000 and hepatitis B virus-DNA > 2000 groups, n (%)
RECIST 1.1 | P value | mRECIST | P value | |||
HBV ≤ 2000, n = 66 | HBV > 2000, n = 54 | HBV ≤ 2000, n = 66 | HBV > 2000, n = 54 | |||
CR | 0 | 0 | - | 0 | 0 | - |
PR | 13 (19.70) | 17 (31.48) | 0.14 | 15 (22.73) | 18 (33.33) | 0.20 |
SD | 35 (53.03) | 21 (38.89) | 0.12 | 37 (56.06) | 23 (42.59) | 0.14 |
PD | 18 (27.27) | 16 (29.63) | 0.78 | 14 (21.21) | 13 (24.07) | 0.71 |
ORR | 13 (19.70) | 18 (33.33) | 0.09 | 15 (22.73) | 22 (40.74) | 0.03 |
DCR | 48 (72.73) | 40 (74.07) | 0.87 | 52 (78.79) | 41 (75.93) | 0.71 |
Table 3 Subgroup analysis of tumour response according to whether or not they received antiviral therapy, n (%)
Antiviral therapy (no), n = 25 | Antiviral therapy (yes), n = 95 | |||||
HBV-DNA (HBV > 2000), n = 8 | HBV-DNA (HBV ≤ 2000), n = 18 | P value | HBV-DNA (HBV > 2000), n = 46 | HBV-DNA (HBV ≤ 2000), n = 48 | P value | |
PR | 2 (29) | 3 (17) | 0.597 | 15 (32) | 10 (21) | 0.220 |
SD | 3 (43) | 11 (61) | 0.656 | 18 (38) | 24 (50) | 0.251 |
PD | 2 (29) | 4 (22) | > 0.999 | 14 (30) | 14 (29) | 0.947 |
ORR | 2 (29) | 3 (17) | 0.597 | 16 (34) | 10 (21) | 0.149 |
DCR | 5 (71) | 14 (78) | > 0.999 | 35 (74) | 34 (71) | 0.691 |
ORR (whole) | 5 (20) | - | 26 (27) | 0.454 | ||
DCR (whole) | 6 (24) | - | 26 (27) | 0.735 |
Table 4 Univariate and multivariate analyses of the prognostic factors for progression-free survival
Factors | Univariate | Multivariate | ||
HR (95%CI) | P value | HR (95%CI) | P value | |
AFP (≤ 1210 vs > 1210) | 0.71 (0.46- 1.09) | 0.121 | - | - |
Age (≥ 60 yr vs < 60 yr) | 1.00 (0.65- 1.53) | 0.984 | - | - |
Alcohol (Yes vs No) | 0.93 (0.60- 1.45) | 0.753 | - | - |
ALT (≤ 40 vs No) | 0.81 (0.53- 1.24) | 0.337 | - | - |
Antiviral therapy (Yes vs No) | 0.61 (0.32- 1.16) | 0.132 | - | - |
BCLC stage (C vs B) | 0.55 (0.35 - 0.87) | 0.011 | 0.57 (0.36-0.91) | 0.017 |
BMI (Normal vs Low) | 1.35 (0.61- 3.00) | 0.457 | - | - |
BMI (Over obese vs Low) | 0.46 (0.16- 1.31) | 0.146 | - | - |
BMI (Weight vs Low) | 0.87 (0.53- 1.44) | 0.584 | - | - |
Child Pugh score (B vs C) | 1.34 (0.86- 2.06) | 0.192 | - | - |
Diabetes (Yes vs No) | 1.02 (0.62 - 1.69) | 0.929 | - | - |
Cirrhosis (Yes vs No) | 0.99 (0.64- 1.52) | 0.955 | - | - |
ECOG (2 vs 0-1) | 1.92 (1.25- 2.96) | 0.003 | 1.86 (1.21-2.86) | 0.005 |
HBV (Positive vs Negative) | 1.21 (0.76- 1.94) | 0.417 | - | - |
HBV-DNA (HBV ≤ 2000 vs HBV > 2000) | 1.04 (0.67- 1.60) | 0.877 | - | - |
Hypertensive (Yes vs No) | 0.97 (0.60- 1.56) | 0.904 | - | - |
PVTT (Yes vs No) | 1.36 (0.86- 2.13) | 0.186 | - | - |
Post operative (Yes vs No) | 0.78 (0.50- 1.22) | 0.284 | - | - |
Metastasis (Yes vs No) | 0.73 (0.47- 1.14) | 0.164 | - | - |
Sex (male vs No) | 0.83 (0.54- 1.28) | 0.395 | - | - |
Smoking (Yes vs No) | 0.95 (0.59- 1.53) | 0.834 | - | - |
Total bilirubin (≤ 34 vs > 34) | 0.92 (0.57- 1.48) | 0.726 | - | - |
Virus reactivation (Yes vs No) | 1.30 (0.18- 9.43) | 0.798 | - | - |
Table 5 Univariate and multivariate analyses of the prognostic factors for overall survival
Factors | Univariate | Multivariate | ||
HR (95%CI) | P value | HR (95%CI) | P value | |
AFP (≤ 1210 vs > 1210) | 0.57 (0.36-0.92) | 0.020 | 0.95 (0.56-1.60) | 0.849 |
Age (≥ 60 yr vs < 60 yr) | 0.89 (0.57-1.39) | 0.618 | - | - |
Alcohol (Yes vs No) | 0.93 (0.59-1.46) | 0.750 | - | - |
ALT (≤ 40 vs No) | 1.29 (0.83-2.02) | 0.256 | - | - |
Antiviral therapy (Yes vs No) | 0.23 (0.12-0.44) | <0.001 | 0.43 (0.20-0.89) | 0.024 |
BCLC stage (C vs B) | 2.44 (1.48-4.05) | 0.001 | 2.22 (1.27-3.86) | 0.005 |
BMI (Normal vs Low) | 0.61 (0.26-1.45) | 0.265 | - | - |
BMI (Over obese vs Low) | 2.86 (1.00-8.21) | 0.051 | - | - |
BMI over (Weight vs Low) | 0.83 (0.51-1.37) | 0.469 | - | - |
Child Pugh score (B vs C) | 1.01 (0.65-1.59) | 0.952 | - | - |
Diabetes (Yes vs No) | 0.97 (0.57-1.66) | 0.922 | - | - |
Cirrhosis (Yes vs No) | 1.16 (0.74-1.83) | 0.515 | - | - |
ECOG (2 vs 0-1) | 0.98 (0.63-1.53) | 0.937 | - | - |
HBV (Positive vs Negative) | 1.03 (0.63-1.66) | 0.914 | - | - |
HBV-DNA (HBV ≤ 2000 vs HBV > 2000) | 0.71 (0.45-1.12) | 0.142 | - | - |
Hypertensive (Yes vs No) | 1.07 (0.65-1.76) | 0.781 | - | - |
PVTT (Yes vs No) | 2.64 (1.61-4.31) | < 0.001 | 2.28 (1.29-4.05) | 0.005 |
Post operative (Yes vs No) | 1.18 (0.75-1.88) | 0.472 | - | - |
Metastasis (Yes vs No) | 0.65 (0.41-1.04) | 0.071 | - | - |
Sex (male vs No) | 1.00 (0.64-1.56) | 0.994 | - | - |
Smoking (Yes vs No) | 1.25 (0.77-2.04) | 0.374 | - | - |
Total bilirubin (≤ 34 vs > 34) | 0.86 (0.53-1.39) | 0.533 | - | - |
Virus reactivation (Yes vs No) | 1.29 (0.18-9.35) | 0.803 | - | - |
Table 6 Comparison of training set and validation set features, n (%)
Characteristic | Training cohort, n = 84 | Internal test cohort, n = 36 | P value |
HBV-DNA | 0.749 | ||
> 2000 | 37 (44) | 17 (47) | |
≤ 2000 | 47 (56) | 19 (53) | |
HBV | 0.001 | ||
Negative | 67 (80) | 18 (50) | |
Positive | 17 (20) | 18 (50) | |
Antiviral therapy | 0.806 | ||
No | 18 (21) | 7 (19) | |
Yes | 66 (79) | 29 (81) | |
Child Pugh score | 0.022 | ||
A | 30 (36) | 21 (58) | |
B | 54 (64) | 15 (42) | |
PVTT | 0.780 | ||
No | 42 (50) | 19 (53) | |
Yes | 42 (50) | 17 (47) | |
BCLC stage | 0.690 | ||
B | 41 (49) | 19 (53) | |
C | 43 (51) | 17 (47) | |
Metastasis | 0.936 | ||
No | 46 (55) | 20 (56) | |
Yes | 38 (45) | 16 (44) | |
AFP | 0.035 | ||
> 1210 | 48 (57) | 13 (36) | |
≤ 1210 | 36 (43) | 23 (64) | |
Sex | 0.837 | ||
Female | 31 (37) | 14 (39) | |
Male | 53 (63) | 22 (61) | |
Age | 0.968 | ||
< 60 | 44 (52) | 19 (53) | |
≥ 60 | 40 (48) | 17 (47) | |
BMI | 0.333 | ||
Low | 48 (57) | 25 (69) | |
Normal | 5 (6.0) | 3 (8.3) | |
Obese | 5 (6.0) | 0 (0) | |
Overweight | 26 (31) | 8 (22) | |
ECOG | 0.491 | ||
0-1 | 48 (57) | 23 (64) | |
2 | 36 (43) | 13 (36) | |
Post operative | 0.569 | ||
No | 49 (58) | 23 (64) | |
Yes | 35 (42) | 13 (36) | |
ALT | 0.262 | ||
> 40 | 35 (42) | 19 (53) | |
≤ 40 | 49 (58) | 17 (47) | |
Total bilirubin | 0.049 | ||
> 34 | 62 (74) | 20 (56) | |
≤ 34 | 22 (26) | 16 (44) | |
Diabetes | 0.066 | ||
No | 59 (70) | 31 (86) | |
Yes | 25 (30) | 5 (14) | |
Hypertensive | 0.827 | ||
No | 24 (29) | 11 (31) | |
Yes | 60 (71) | 25 (69) | |
Cirrhosis | 0.245 | ||
No | 44 (52) | 23 (64) | |
Yes | 40 (48) | 13 (36) | |
Smoking | 0.365 | ||
No | 56 (67) | 27 (75) | |
Yes | 28 (33) | 9 (25) | |
Alcohol | 0.228 | ||
No | 51 (61) | 26 (72) | |
Yes | 33 (39) | 10 (28) | |
Virus reactivation | 0.512 | ||
No | 83 (99) | 35 (97) | |
Yes | 1 (1) | 1 (3) |
Table 7 Treatment-related adverse events in patients with hepatocellular carcinoma, n (%)
Variable | Group | P value | |
HBV-DNA > 2000, n = 54 | HBV-DNA ≤ 2000, n = 66 | ||
Rash | 4 (7) | 6 (9) | > 0.999 |
Nausea | 7 (13) | 13 (20) | 0.325 |
Diarrhea | 5 (9) | 5 (8) | 0.752 |
Fatigue | 4 (7) | 6 (9) | > 0.999 |
Myocarditis | 6 (11) | 6 (9) | 0.714 |
Hyperbilirubinemia | 5 (9) | 8 (12) | 0.616 |
Hypertension | 5 (9) | 7 (11) | 0.807 |
Leukopenia | 6 (11) | 8 (12) | 0.864 |
Thrombocytopenia | 7 (13) | 10 (15) | 0.732 |
RCCEP | 23 (43) | 31 (47) | 0.632 |
Neutropenia | 4 (7) | 7 (11) | 0.752 |
Proteinuria | 14 (26) | 18 (27) | 0.868 |
Hypothyroidism | 5 (9) | 5 (8) | 0.752 |
Elevated ALT | 4 (7) | 7 (11) | 0.752 |
Elevated AST | 7 (13) | 6 (9) | 0.497 |
- Citation: Pan D, Liu HN, Yao ZY, Chen XX, Li YQ, Zhu JJ, Han ZX, Qin XB. Impact of baseline hepatitis B virus viral load on the long-term prognosis of advanced hepatocellular carcinoma treated with immunotherapy. World J Gastrointest Oncol 2024; 16(6): 2504-2519
- URL: https://www.wjgnet.com/1948-5204/full/v16/i6/2504.htm
- DOI: https://dx.doi.org/10.4251/wjgo.v16.i6.2504