Table 1 Baseline patient demographics and clinical characteristics in ITT population (n = 108)

From: Combined FOLFOX4 with all-trans retinoic acid versus FOLFOX4 with placebo in treatment of advanced hepatocellular carcinoma with extrahepatic metastasis: a randomized, double-blind comparative study

Variables

ATRA-FOLFOX (n = 53)

FOLFOX (n = 55)

P value

Age

51.8 ± 10.8

51.8 ± 12.3

0.930

Sex

  

0.449

 Male

47 (88.7%)

46 (83.6%)

 

 Female

6 (11.3%)

9 (16.4%)

 

HBV-DNA

  

0.447

 Negative

17 (32.1%)

14 (25.5%)

 

 Positive

36 (67.9%)

41 (74.5%)

 

α-fetoprotein

  

0.363

 ≥ 400 μg/l

22 (41.5%)

26 (47.3%)

 

 < 400 μg/l

31 (58.5%)

29 (52.7%)

 

Platelet

  

0.333

 ≥ 100 × 109/L

35 (66.0%)

41 (74.5%)

 

 < 100 × 109/L

18 (34.0%)

14 (25.5%)

 

White blood cell

  

0.241

 ≥ 4.0 × 109/L

34 (64.2%)

41 (74.5%)

 

 < 4.0 × 109/L

19 (35.8%)

14 (25.5%)

 

Alanine aminotransferase

  

0.221

 > 44 U/L

5 (9.4%)

2 (3.6%)

 

 ≤ 44 U/L

48 (90.6%)

53 (96.4%)

 

Total bilirubin

  

0.459

 > 17.1 μmol/L

13 (24.5%)

17 (30.9%)

 

 ≤ 17.1 μmol/L

40 (75.5%)

38 (69.1%)

 

Hepatic tumor stage

  

0.253

 T0/T1

27 (50.9%)

24 (43.6%)

 

 T2

7 (13.2%)

4 (7.3%)

 

 T3

3 (5.7%)

9 (16.4%)

 

 T4

16 (30.2%)

18 (32.7)

 

Regional lymph node stage

  

0.468

 N0

47 (88.7%)

51 (92.7%)

 

 N1

6 (11.3%)

4 (7.3%)

 

Metastatic organs

  

0.432

 Lung

41(77.4%)

43(78.2%)

 

 Bone

3 (5.7%)

4 (7.3%)

 

 Abdominal

4 (7.5%)

10 (18.2%)

 

 Other

6 (11.3%)

4 (7.3%)

 

Number of extrahepatic metastatic lesions

  

0.733

 ≥3

34 (64.1%)

37 (67.3%)

 

 <3

19 (35.9%)

18 (32.7%)

 

Portal vein tumor thrombus (PVTT)

  

0.776

 Yes

16 (25.9%)

18 (15.8%)

 

ABLI score

  

0.339

 1

28 (52.8%)

29 (52.7%)

 

 2

23 (43.4%)

26 (42.3%)

 

 3

2 (3.8%)

0 (0.0%)

 

 Chemotherapy cycles

4.0 ± 2.0

3.9 ± 2.1

0.887

Treatments of extrahepatic lesions before enrolled

  

0.222

 None

37 (69.8%)

44 (80.0%)

 

 Targeted therapy and /or immunotherapy

16 (30.2%)

11 (20.0%)