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Table 1 Baseline characteristics of the included patients (n = 114) and the primary outcome

From: Hepatitis B virus reactivation in cancer patients with positive Hepatitis B surface antigen undergoing PD-1 inhibition

 No. of patients (%)No. of HBV reactivation events (%)OR (95% CI)P valuea
Age
 <4026 (22.8)2 (7.7)1.75 (0.30–10.14)0.895
 ≥4088 (77.2)4 (4.5)1 
 Median age (range), years46 (16–76)
Gender
 Male90 (78.9)5 (5.6)1.35 (0.30–10.14)1.000
 Female24 (21.1)1 (4.2)1 
Cancer type
 Hepatocellular carcinoma28 (24.6)1 (3.6)0.54 (0.060–4.84)0.667
 Lymphoma8 (7.0)0 (0)0.87 (0.040–15.49) 
 Othersb78 (68.4)5 (6.4)1 
ECOG performance status
 ≤194 (82.5)6 (6.4)3.01 (0.16–55.63)0.542
 >120 (17.5)0 (0)1 
History of alcoholism
 Yes17 (14.9)0 (0)0.40 (0.022–7.47)0.589
 No97 (85.1)6 (6.2)1 
Liver involvementc
 Yes73 (64.0)3 (4.1)0.54 (0.10–2.82)0.765
 No41 (36.0)3 (7.3)1 
Liver cirrhosis
 Yes33 (28.9)1 (3.0)0.48 (0.053–4.23)0.827
 No81 (81.1)5 (6.2)1 
HBeAg status
 Seropositived12 (10.5)2 (16.7)6.25 (0.99–39.50)0.086
 Seronegative102 (89.5)4 (3.9)1 
Baseline HBV DNA level
 Detectablee35 (30.7)0 (0)0.16 (0.0087–2.91)0.222
 Undetectable79 (69.3)6 (7.6)1 
 Median baseline HBV DNA (range), IU/mL0 (0–2.48 × 105)
Previous lines of therapy
 <270 (61.4)3 (4.3)0.61 (0.12–3.18)0.874
 ≥244 (38.6)3 (6.8)1 
Treatment modality
 PD-1/PD-L1 inhibitorf monotherapy83 (72.8)6 (7.2)5.28 (0.29–96.62)0.286
 Combination therapyg31 (27.2)0 (0)1 
Concurrent steroidsh
 Yes14 (12.3)1 (7.1)1.46 (0.15–13.51)0.553
 No100 (87.7)5 (5.0)1 
Antiviral prophylaxis
 No29 (25.4)5 (17.2)17.50 (1.95–157.07)0.004
 Yesi85 (74.6)1 (1.2)1 
Antiviral prophylaxis agents
 Entecavir68 (59.6)1NCNC
 Lamivudine10 (8.8)0NC 
 Tenofovir5 (4.4)0NC 
 Telbivudine1 (0.9)0NC 
 Adefovir1 (0.9)0NC 
 Nil29 (25.4)5NC 
  1. aCalculated using the χ2 test except for history of alcoholism, HBeAg status and concurrent steroids which were calculated using the Fisher exact test
  2. 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)
  3. cIncluding primary liver cancer and liver metastasis
  4. dOne did not received antiviral prophylaxis; 10 received entecavir and 1 received tenofovir as antiviral prophylaxis
  5. eHBV DNA ≥ 10 IU/mL
  6. fIncluding pembrolizumab, nivolumab, toripalimab, camrelizumab, sintilimab, atezolizumab
  7. 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)
  8. hSystemic steroids for any reason during immunotherapy, including premedication, treatment for high intracranial pressure and treatment for immune-related adverse events
  9. iIncluding entecavir (n = 68), lamivudine (n = 10), tenofovir (n = 5), telbivudine (n = 1) and adefovir (n = 1)
  10. 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