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Table 1 Baseline characteristics of Child–Pugh B subgroup

From: Safety and efficacy of cabozantinib for patients with advanced hepatocellular carcinoma who advanced to Child–Pugh B liver function at study week 8: a retrospective analysis of the CELESTIAL randomised controlled trial

 

Child–Pugh B subgroup

Overall populationa

Cabozantinib

(N = 51)

Placebo

(N = 22)

Total

(N = 73)

Cabozantinib

(N = 470)

Placebo

(N = 237)

Total

(N = 707)

Median age (range), years

63.0 (22–82)

64.5 (50–85)

64.0 (22–85)

64 (22–86)

64 (24–86)

64 (22–86)

Male, n (%)

45 (88)

20 (91)

65 (89)

379 (81)

202 (85)

581 (82)

Geographic region, n (%)

      

  Asia

14 (27)

3 (14)

17 (23)

116 (25)

59 (25)

175 (25)

  Europe

21 (41)

12 (55)

33 (45)

231 (49)

108 (46)

339 (48)

  Australian/New Zealand

1 (2)

1 (5)

2 (3)

15 (3)

11 (5)

26 (4)

  Canada/USA

15 (29)

6 (27)

21 (29)

108 (23)

59 (25)

167 (24)

Race, n (%)

      

  Asian

17 (33)

5 (23)

22 (30)

159 (34)

82 (35)

241 (34)

  White

30 (59)

14 (64)

44 (60)

264 (56)

130 (55)

394 (56)

  Black

0

2 (9)

2 (3)

8 (2)

11 (5)

19 (3)

  Other

1 (2)

1 (5)

2 (3)

8 (2)

2 (1)

10 (1)

  Not reported

3 (6)

0

3 (4)

31 (7)

12 (5)

43 (6)

ECOG status, n (%)

      

  0

27 (53)

12 (55)

39 (53)

245 (52)

131 (55)

376 (53)

  1

24 (47)

10 (45)

34 (47)

224 (48)

106 (45)

330 (47)

  2

0

0

0

1 (< 1)

0

1 (< 1)

Aetiology of disease, n (%)

      

  HBV

18 (35)

6 (27)

24 (33)

178 (38)

89 (38)

267 (38)

  HCV

16 (31)

4 (18)

20 (27)

113 (24)

55 (23)

168 (24)

  Alcohol use

19 (37)

4 (18)

23 (32)

112 (24)

39 (16)

151 (21)

  Nonalcoholic steatohepatitis

3 (6)

2 (9)

5 (7)

43 (9)

23 (10)

66 (9)

AFP, n (%)

      

  < 400 ng/mL

31 (61)

16 (73)

47 (64)

278 (59)

136 (57)

414 (59)

  ≥ 400 ng/mL

20 (39)

6 (27)

26 (36)

192 (41)

101 (43)

293 (41)

Albumin, n (%)

      

  < 35 g/L

27 (53)

11 (50)

38 (52)

131 (28)

60 (25)

191 (27)

  ≥ 35 g/L

24 (47)

11 (50)

35 (48)

339 (72)

177 (75)

516 (73)

Bilirubin, n (%)

      

  < 22.23 µmol/L

40 (78)

20 (91)

60 (82)

421 (90)

221 (93)

642 (91)

  ≥ 22.23– < 29.07 µmol/L

6 (12)

2 (9)

8 (11)

37 (8)

13 (5)

50 (7)

  ≥ 29.07 µmol/L

5 (10)

0

5 (7)

12 (3)

3 (1)

15 (2)

Extrahepatic spread of disease and/or macrovascular invasion, n (%)

47 (92)

17 (77)

64 (88)

398 (85)

200 (84)

598 (85)

  Extrahepatic spread of disease

42 (82)

15 (68)

57 (78)

369 (79)

182 (77)

551 (78)

  Macrovascular invasion

22 (43)

7 (32)

29 (40)

129 (27)

81 (34)

210 (30)

ALBI grade, n (%)

      

  1

5 (10)

1 (5)

6 (8)

186 (40)

102 (43)

288 (41)

  2

45 (88)

21 (95)

66 (90)

282 (60)

133 (56)

415 (59)

  3

1 (2)

0

1 (1)

2 (< 1)

2 (1)

4 (1)

Child–Pugh score, n (%)b

      

  5

13 (25)

7 (32)

20 (27)

264 (56)

153 (65)

417 (59)

  6

33 (65)

14 (64)

47 (64)

183 (39)

78 (33)

261 (37)

  ≥ 7

4 (8)

1 (5)

5 (7)

17 (4)

5 (2)

22 (3)

  Missing

1 (2)

0

1 (1)

6 (1)

1 (< 1)

7 (1)

Sites of disease, n (%)

      

  Liver

45 (88)

21 (95)

66 (90)

395 (84)

216 (91)

611 (86)

  Bone

9 (18)

2 (9)

11 (15)

60 (13)

34 (14)

94 (13)

  Visceral (excluding liver)

24 (47)

9 (41)

33 (45)

215 (46)

105 (44)

320 (45)

  Lymph node

19 (37)

3 (14)

22 (30)

155 (33)

71 (30)

226 (32)

Number of prior systemic anticancer regimens for advanced HCC, n (%)

      

  0

1 (2)

0

1 (1)

3 (1)

0

3 (< 1)

  1

33 (65)

13 (59)

46 (63)

335 (71)

174 (73)

509 (72)

  2

16 (31)

9 (41)

25 (34)

130 (28)

62 (26)

192 (27)

  ≥ 3

1 (2)

0

1 (1)

2 (< 1)

1 (< 1)

3 (< 1)

TACE for HCC, N (%)

26 (51)

13 (59)

39 (53)

203 (43)

111 (47)

314 (44)

Median total duration of prior sorafenib (range), months

5.4 (1.1–40.0)

7.1 (1.0–29.2)

5.4 (1.0–40.0)

5.3 (0.3–70.0)

4.8 (0.2–76.8)

5.2 (0.2–76.8)

Median time from disease progression to randomisation (range), moc

1.5 (0.2–100.8)

1.9 (0.4–69.4)

1.5 (0.2–100.8)

1.6 (0–100.8)

1.7 (0.2–69.4)

1.6 (0–100.8)

  1. aData from Abou-Alfa et al. N. Engl. J. Med. 379, 54–63 (2018) [11]. bAs Child–Pugh grading was investigator assessed and Child–Pugh scoring was determined retrospectively by BCDM, some discrepancies between grading and scoring results existed. cn = 49 and 21 for cabozantinib and placebo cohorts, respectively. AFP alpha fetoprotein, ALBI albumin-bilirubin, BCDM Biostatistics and Clinical Data Management, ECOG Eastern Cooperative Oncology Group, HBV hepatitis B virus, HCV hepatitis C virus, TACE transarterial chemoembolisation