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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

 <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

 
  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