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