Table 1 Phase-II patient baseline demographics and clinical characteristicsa

From: A multicentre, open-label, phase-I/randomised phase-II study to evaluate safety, pharmacokinetics, and efficacy of nintedanib vs. sorafenib in European patients with advanced hepatocellular carcinoma

Characteristic

Nintedanib, 200 mg bid (n = 62)

Sorafenib, 400 mg bid (n = 31)

Total (N = 93)

Median age, years (range)

66 (34–86)

64 (28–83)

66 (28–86)

Male sex, n (%)

48 (77.4)

26 (83.9)

74 (79.6)

Race, n (%)

 Indian

0 (0.0)

3 (9.7)

3 (3.2)

 Taiwanese or Chinese

0 (0.0)

1 (3.2)

1 (1.1)

 Black

0 (0.0)

1 (3.2)

1 (1.1)

 Caucasian

57 (91.9)

24 (77.4)

81 (87.1)

 Missing

5 (8.1)

2 (6.5)

7 (7.5)

Median time since diagnosis, months (range)

2.53 (0–101.4)

2.76 (0.2–77.5)

2.53 (0–101.4)

ECOG PS, n (%)

 0

32 (51.6)

18 (58.1)

50 (53.8)

 1

28 (45.2)

10 (32.3)

38 (40.9)

 2

2 (3.2)

3 (9.7)

5 (5.4)

Child–Pugh score, n (%)

 5

42 (67.7)

23 (74.2)

65 (69.9)

 6

19 (30.6)

8 (25.8)

27 (29.0)

 7b

1 (1.6)

0 (0.0)

1 (1.1)

BCLC stage, n (%)

 0

0 (0.0)

1 (3.2)

1 (1.1)

 A

1 (1.6)

0 (0.0)

1 (1.1)

 B

15 (24.2)

7 (22.6)

22 (23.7)

 C

45 (72.6)

23 (74.2)

68 (73.1)

 D

1 (1.6)

0 (0.0)

1 (1.1)

MVI, n (%)

22 (35.5)

9 (29.0)

31 (33.3)

EHS, n (%)

40 (64.5)

21 (67.7)

61 (65.6)

Location of EHS, n (%)

 Bone

6 (9.7)

5 (16.1)

11 (11.8)

 Lung

16 (25.8)

6 (19.4)

22 (23.7)

 Lymph

26 (41.9)

9 (29.0)

35 (37.6)

 Other

11 (17.7)

7 (22.6)

18 (19.4)

Aetiology of parenchymal liver disease, n (%)

 Alcohol related

10 (16.1)

3 (9.7)

13 (14.0)

 HBV related

4 (6.5)

7 (22.6)

11 (11.8)

 HCV related

13 (21.0)

8 (25.8)

21 (22.6)

 HBV + HCV related

0 (0.0)

0 (0.0)

0 (0.0)

 Unknown

23 (37.1)

8 (25.8)

31 (33.3)

 Other

12 (19.4)

5 (16.1)

17 (18.3)

Parenchymal liver disease, n (%)

 Chronic hepatitis

8 (12.9)

5 (16.1)

13 (14.0)

 Steatofibrosis

3 (4.8)

2 (6.5)

5 (5.4)

 Cirrhosis

29 (46.8)

20 (64.5)

49 (52.7)

 No evidence

15 (24.2)

1 (3.2)

16 (17.2)

 Unknown

6 (9.7)

3 (9.7)

9 (9.7)

 Other

1 (1.6)

0 (0.0)

1 (1.1)

Type of local therapy, n (%)

 Complete surgical resection

9 (14.5)

3 (9.7)

12 (12.9)

 RFA

2 (3.2)

0 (0.0)

2 (2.2)

 PEI

0 (0.0)

0 (0.0)

0 (0.0)

 TACE

19 (30.6)

10 (32.3)

29 (31.2)

 RT

1 (1.6)

0 (0.0)

1 (1.1)

 Other

2 (3.2)

4 (12.9)

6 (6.5)

Stratification group, n (%)

 I: EHS and/or MVI present

49 (79.0)

23 (74.2)

72 (77.4)

 II: EHS and MVI both absent

13 (21.0)

8 (25.8)

21 (22.6)

  1. BCLC Barcelona Clinic Liver Cancer, ECOG PS Eastern Cooperative Oncology Group performance status, EHS extrahepatic spread, HBV hepatitis B, HCV hepatitis C, MVI macrovascular invasion, PEI percutaneous ethanol injection, RFA radiofrequency ablation, RT radiotherapy, TACE transarterial chemoembolisation.
  2. aα-fetoprotein (AFP) groups are not shown because there were too many missing values because a lot of investigative sites measured activated AFP instead of AFP and there is no transformation of the values available.
  3. bThis patient with a Child–Pugh score of 7 in the nintedanib group was a protocol deviation
Back to article page