Table 1.
Baseline characteristics of the included patients (n = 114) and the primary outcome
| No. of patients (%) | No. of HBV reactivation events (%) | OR (95% CI) | P valuea | |
|---|---|---|---|---|
| Age | ||||
| <40 | 26 (22.8) | 2 (7.7) | 1.75 (0.30–10.14) | 0.895 |
| ≥40 | 88 (77.2) | 4 (4.5) | 1 | |
| Median age (range), years | 46 (16–76) | |||
| Gender | ||||
| Male | 90 (78.9) | 5 (5.6) | 1.35 (0.30–10.14) | 1.000 |
| Female | 24 (21.1) | 1 (4.2) | 1 | |
| Cancer type | ||||
| Hepatocellular carcinoma | 28 (24.6) | 1 (3.6) | 0.54 (0.060–4.84) | 0.667 |
| Lymphoma | 8 (7.0) | 0 (0) | 0.87 (0.040–15.49) | |
| Othersb | 78 (68.4) | 5 (6.4) | 1 | |
| ECOG performance status | ||||
| ≤1 | 94 (82.5) | 6 (6.4) | 3.01 (0.16–55.63) | 0.542 |
| >1 | 20 (17.5) | 0 (0) | 1 | |
| History of alcoholism | ||||
| Yes | 17 (14.9) | 0 (0) | 0.40 (0.022–7.47) | 0.589 |
| No | 97 (85.1) | 6 (6.2) | 1 | |
| Liver involvementc | ||||
| Yes | 73 (64.0) | 3 (4.1) | 0.54 (0.10–2.82) | 0.765 |
| No | 41 (36.0) | 3 (7.3) | 1 | |
| Liver cirrhosis | ||||
| Yes | 33 (28.9) | 1 (3.0) | 0.48 (0.053–4.23) | 0.827 |
| No | 81 (81.1) | 5 (6.2) | 1 | |
| HBeAg status | ||||
| Seropositived | 12 (10.5) | 2 (16.7) | 6.25 (0.99–39.50) | 0.086 |
| Seronegative | 102 (89.5) | 4 (3.9) | 1 | |
| Baseline HBV DNA level | ||||
| Detectablee | 35 (30.7) | 0 (0) | 0.16 (0.0087–2.91) | 0.222 |
| Undetectable | 79 (69.3) | 6 (7.6) | 1 | |
| Median baseline HBV DNA (range), IU/mL | 0 (0–2.48 × 105) | |||
| Previous lines of therapy | ||||
| <2 | 70 (61.4) | 3 (4.3) | 0.61 (0.12–3.18) | 0.874 |
| ≥2 | 44 (38.6) | 3 (6.8) | 1 | |
| Treatment modality | ||||
| PD-1/PD-L1 inhibitorf monotherapy | 83 (72.8) | 6 (7.2) | 5.28 (0.29–96.62) | 0.286 |
| Combination therapyg | 31 (27.2) | 0 (0) | 1 | |
| Concurrent steroidsh | ||||
| Yes | 14 (12.3) | 1 (7.1) | 1.46 (0.15–13.51) | 0.553 |
| No | 100 (87.7) | 5 (5.0) | 1 | |
| Antiviral prophylaxis | ||||
| No | 29 (25.4) | 5 (17.2) | 17.50 (1.95–157.07) | 0.004 |
| Yesi | 85 (74.6) | 1 (1.2) | 1 | |
| Antiviral prophylaxis agents | ||||
| Entecavir | 68 (59.6) | 1 | NC | NC |
| Lamivudine | 10 (8.8) | 0 | NC | |
| Tenofovir | 5 (4.4) | 0 | NC | |
| Telbivudine | 1 (0.9) | 0 | NC | |
| Adefovir | 1 (0.9) | 0 | NC | |
| Nil | 29 (25.4) | 5 | NC | |
aCalculated using the χ2 test except for history of alcoholism, HBeAg status and concurrent steroids which were calculated using the Fisher exact test
bIncluding nasopharyngeal carcinoma (n = 35), melanoma (n = 14), non-small cell lung cancer (n = 13), colorectal cancer (n = 4), gastric cancer (n = 2), esophageal cancer (n = 2), head and neck squamous cancer (n = 1), urothelial carcinoma (n = 1), breast cancer (n = 1), soft tissue sarcoma (n = 1), ovarian cancer (n = 1), neuroendocrine carcinoma of the skin (Merkle cell carcinoma, n = 1) and carcinoma of unknown primary origin (n = 2)
cIncluding primary liver cancer and liver metastasis
dOne did not received antiviral prophylaxis; 10 received entecavir and 1 received tenofovir as antiviral prophylaxis
eHBV DNA ≥ 10 IU/mL
fIncluding pembrolizumab, nivolumab, toripalimab, camrelizumab, sintilimab, atezolizumab
gIncluding PD-1/PD-L1 inhibitor plus chemotherapy (n = 22), targeted agent (osimertinib [n = 1], bevacizumab [n = 1], regorafenib [n = 1], apatinib [n = 1], sunitinib [n = 1], nimotuzumab [n = 2], cetuximab [n = 1]) and ipilimumab (n = 2)
hSystemic steroids for any reason during immunotherapy, including premedication, treatment for high intracranial pressure and treatment for immune-related adverse events
iIncluding entecavir (n = 68), lamivudine (n = 10), tenofovir (n = 5), telbivudine (n = 1) and adefovir (n = 1)
Abbreviations: HBV hepatitis B virus, OR odds ratio, CI confidence interval, ECOG Eastern Cooperative Oncology Group, HBeAg Hepatitis B e antigen, HBV hepatitis B virus, PD-1, programmed cell death protein-1, PD-L1 programmed cell death-ligand 1, NC not computable