Table 1.
Baseline characteristics of the included patients (n = 301)
| No. of patients (%) | No. of any-grade hepatotoxicity (%) | Pa | No. of grade 3–4 hepatotoxicity (%) | Pa | |
|---|---|---|---|---|---|
| Total | 301 (100%) | 51 (16.9%) | 14 (4.7%) | ||
| Age (years, range 44–84) | 0.813 | 0.365 | |||
| > 52 | 143 (47.5) | 25 (17.4) | 5 (3.5) | ||
| ≤ 52 | 158 (52.5) | 26 (16.5) | 9 (5.7) | ||
| Gender | 0.409 | 0.226 | |||
| Male | 215 (71.4) | 34 (15.8) | 8 (3.7) | ||
| Female | 86 (28.6) | 17 (19.8) | 6 (7.0) | ||
| Body weight(kg) | 0.813 | 0.848 | |||
| > 60 | 143 (47.5) | 25 (17.5) | 7 (4.9) | ||
| ≤ 60 | 158 (52.5) | 26 (16.5) | 7 (4.4) | ||
| History of alcoholism | 0.900 | 0.091 | |||
| Yes | 49 (16.3) | 8 (16.3) | 0 (0.0) | ||
| No | 252 (83.7) | 43 (17.1) | 14 (5.6) | ||
| bHTN/DM/CVD | 0.858 | 0.334 | |||
| Yes | 39 (13.0) | 7 (17.9) | 3 (7.7) | ||
| No | 262 (87.0) | 44 (16.8) | 11 (4.2) | ||
| Liver cirrhosis | 0.790 | 0.030 | |||
| Yes | 21 (7.0) | 4 (19.0) | 3 (13.6) | ||
| No | 280 (93.0) | 47 (16.8) | 11 (3.9) | ||
| Hepatocellular carcinoma | 0.320 | 0.023 | |||
| Yes | 20 (6.6) | 5 (25.0) | 3 (15.0) | ||
| Noc | 281 (93.4) | 46 (16.4) | 11 (3.9) | ||
| HBsAg status | 0.757 | 0.004 | |||
| Seropositive | 89 (29.6) | 16 (18.0) | 9 (10.0) | ||
| Seronegative | 212 (70.4) | 35 (16.5) | 5 (23.6) | ||
| HBeAg status | 0.116 | 0.006 | |||
| Seropositive | 8 (2.7) | 3 (37.5) | 2 (25%) | ||
| Seronegative | 293 (97.3) | 48 (16.4) | 12 (4.1) | ||
| ECOG performance status | 0.227 | 0.665 | |||
| > 1 | 32 (10.6) | 3 (9.4) | 1 (3.1) | ||
| ≤ 1 | 269 (89.4) | 48 (17.8) | 13 (4.8) | ||
| Lines of treatment | 0.464 | 0.694 | |||
| > 2 | 114 (37.8) | 17 (14.9) | 6 (5.2) | ||
| ≤ 2 | 187 (62.1) | 34 (18.2) | 8 (4.3) | ||
| Liver involvementd | 0.022 | 0.016 | |||
| Yes | 122 (40.5) | 28 (23.0) | 10 (8.1) | ||
| No | 179 (59.5) | 23 (12.8) | 4 (2.2) | ||
| Antiviral therapye | 0.527 | 0.472 | |||
| Yes | 63 (20.9) | 9 (14.3) | 4 (6.3) | ||
| No | 238 (79.1) | 42 (17.6) | 10 (4.2) | ||
| Baseline HBV DNA level | 0.026 | 0.000 | |||
| Undetectablef | 101 (33.6) | 9 (8.9) | 4 (4.0) | ||
| Detectable | 24 (8.0) | 6 (25.0) | 5 (20.8) | ||
| Unknown | 176 (58.4) | 36 (20.5) | 5 (2.8) | ||
| Treatment modality | 0.141 | 0.307 | |||
| Combined therapyg | 92 (30.6) | 20 (21.7) | 6 (6.5) | ||
| Monotherapyh | 209 (69.4) | 31 (14.8) | 8 (3.8) |
aDetermined using a χ2 test
bAbbreviations: HTN hypertension; DM diabetes mellitus; CVD cardiovascular disease
cIncluding nasopharyngeal carcinoma (n = 84), non-small-cell lung cancer (n = 66), melanoma (n = 38), gastric cancer (n = 24), colorectal cancer (n = 8), lymphoma (n = 21), urothelial carcinoma (n = 5), esophageal cancer (n = 5), gallbladder carcinoma (n = 1), spongiocytoma (n = 1), germinoma (n = 1), small-cell carcinoma of the vagina (n = 1), Breast cancer (n = 4), soft tissue sarcoma (n = 4), small-cell lung cancer (n = 4), tumor of unknown original lesion (n = 3), neuroendocrine tumor (n = 3), pancreatic cancer (n = 2), kidney cancer (n = 2), cervical cancer (n = 2), head and neck tumor (n = 2)
dMalignant lesions in the liver, including HCC and liver metastases of non-HCC tumors
eIncluding entecavir (n = 49), lamivudine (n = 9), tenofovir (n = 3), telbivudine (n = 1), adefovir (n = 1)
fHBV DNA < 10 IU/mL
gincluding PD-1 inhibitor plus chemotherapy (n = 50), targeted agent (osimertinib [n = 1], bevacizumab [n = 3], ramucirumab [n = 3], rituximab [n = 1], nimotuzumab [n = 1], sunitinib [n = 1], axitinib [n = 1], Ibrutinib [n = 1], apatinib [n = 1], cabozantinib [n = 1], lenvatinib [n = 4], vemurafenib [n = 1], pazopanib [n = 1], SHR7390 [n = 2]), chemotherapy plus targeted agent (n = 10), and ipilimumab (n = 7)
hIncluding pembrolizumab, nivolumab, toripalimab, camrelizumab, sintilimab
Abbreviations: ECOG Eastern Cooperative Oncology Group; HBV hepatitis B virus; HBeAg hepatitis B e antigen; HBsAg hepatitis B surface antigen