Background
Methods
Study population
Treatment protocol, evaluation of vascularity and adverse events
Statistical analysis
Results
Patient characteristics
Characteristics | Number (%) / mean ± S.D. / median [IQR] |
---|---|
Age at start (year) | 53 ± 12.1/53 [43–61] |
Gender | |
men | 112 (84.8%) |
women | 20 (15.2%) |
Etiology | |
Hepatitis B | 109 (82.6%) |
Hepatitis C | 6 (4.5%) |
Others | 17 (12.9%) |
Child-Pugh class | |
A | 124 (93.9%) |
B | 8 (6.1%) |
Performance status | |
ECOG 0 | 85 (64.4%) |
ECOG 1 | 47 (35.6%) |
BCLC stage | |
A | 10 (7.6%) |
B | 75 (56.8%) |
C | 47 (35.6%) |
Tumor burden | |
Tumor size (cm) | 8.0 ± 3.7/7.1 [5.2–9.8] |
No. of HCC nodules | 2.1 ± 1.9/1 [1–2.25] |
AFP (ng/dl) | 1188.4 ± 2774.7/230.8 [8.7–7713.5] |
Leukocyte (×10E9/L) | 5.9 ± 2.7/5.3 [4.2–6.9] |
Hemoglobin (g/L) | 136.5 ± 20.6/138.0 [126.0–192.5] |
Platelets (×10E9/L) | 150.1 ± 89.3/134.0 [91.0–192.3] |
International normalized ratio | 1.16 ± 0.13/1.10 [1.02–1.17] |
Alanine aminotransferase (U/L) | 45.6 ± 32.3/37 [24.5–57.0] |
Aspartate aminotransferase (U/L) | 53.1 ± 32.7/40.5 [30–69.5] |
Albumin (g/L) | 39.7 ± 5.3/39.8 [36.6–42.5] |
Total bilirubin (μmol/L) | 16.6 ± 6.8/15.3 [11.6–19.6] |
Urea nitrogen (mmol/L) | 5.2 ± 1.7/4.8 [4.2–6] |
Serum creatinine (umol/L) | 84.2 ± 15.9/82.5 [73.8–95.0] |
Hypervascularity as a favorable predictor for response, TTP and OS
HFSR-response as a surrogate marker for combination treatment
Combing vascularity and HFSR for the prediction of outcomes
Validation and adjustment in multivariate analysis
Characteristics | NO. (N1 = 131) | mTTP (month) | Uni-variate HR (95%CI) | p value | Multi-variate HR1a (95%CI) | p value | Multi-variate HR2b (95%CI) | p value |
---|---|---|---|---|---|---|---|---|
Gender (male/female) | 112/19 | 7.3/7.2 | 0.923 (0.549–1.552) | 0.763 | ||||
Age (< 60/≥60 years) | 88/43 | 7.3/7.7 | 1.173 (0.774–1.776) | 0.451 | ||||
Etiology (HBV/other than HBV) | 108/23 | 7.3/7.2 | 1.065 (0.653–1.736) | 0.802 | ||||
PLT (< 150/≥150 × 10E9/L) | 74/57 | 7.8/5.6 | 0.925 (0.630–1.358) | 0.691 | ||||
Albumin (< 35/≥35 g/L) | 20/111 | 12.5/6.7 | 0.850 (0.483–1.494) | 0.571 | ||||
Bilirubin (≥17/< 17 μmol/L) | 50/81 | 6.9/8.3 | 1.159 (0.782–1.720) | 0.462 | ||||
AST (≥40/< 40 U/L) | 68/63 | 5.6/7.8 | 1.246 (0.851–1.823) | 0.258 | ||||
ALT (≥40/< 40 U/L) | 55/76 | 5.8/7.4 | 1.044 (0.708–1.540) | 0.827 | ||||
AFP (≥200/< 200 ng/ml) | 66/65 | 4.9/9.3 | 1.174 (0.800–1.723) | 0.412 | ||||
Ascites (with/without) | 15/116 | 5.7/7.3 | 1.291 (0.688–2.424) | 0.426 | ||||
Child-Pugh score (5/6/≥7) | 103/20/8 | 7.0/6/7/21.7 | 0.919 (0.641–1.316) | 0.644 | ||||
Tumor size (≥7/< 7 cm) | 70/61 | 5.4/10.8 | 1.646 (1.119–2.422) | 0.011 | 1.900 (1.282–2.815) | 0.001 | 1.834(1.239–2.741) | 0.002 |
No. of HCC nodules (≥2/1) | 62/69 | 5.4/9.6 | 1.338 (0.911–1.966) | 0.137 | ||||
Sorafenib usage (after/before TACE) | 43/88 | 7.9/7.2 | 0.998 (0.670–1.488) | 0.993 | ||||
Vascularity (hypovascular/hypervascular) | 43/88 | 3.7/10.2 | 2.643 (1.756–3.978) | < 0.001 | 2.807 (1.848–4.265) | < 0.001 | ||
HFSR (non-responder/responder) | 60/71 | 5.4/9.1 | 1.594 (1.084–2.343) | 0.018 | 1.500 (1.031–2.221) | 0.043 | ||
Stratificationc | ||||||||
Group A | 52 | 12.2 | 1 | 1 | ||||
Group BC | 55 | 6.0 | 1.742 (1.127–2.693) | 0.012 | 1.868 (1.205–2.896) | 0.005 | ||
Group D | 24 | 2.9 | 3.741 (2.166–6.460) | < 0.001 | 4.108 (2.362–7.145) | < 0.001 |
Characteristics | NO. (N2 = 132) | mOS (month) | Uni-variate HR (95%CI) | p value | Multi-variate HR1a (95%CI) | p value | Multi-variate HR2b (95%CI) | p value |
---|---|---|---|---|---|---|---|---|
Gender (male/female) | 112/20 | 21.7/15.8 | 1.095 (0.625–1.917) | 0.752 | ||||
Age (< 60/≥60 years) | 89/43 | 21.0/21.7 | 1.109 (0.720–1.708) | 0.640 | ||||
Etiology (HBV/other than HBV) | 109/23 | 21.0/26.3 | 1.154 (0.688–1.934) | 0.587 | ||||
PLT (< 150/≥150 × 10E9/L) | 74/58 | 21.7/21.4 | 0.970 (0.647–1.457) | 0.885 | ||||
Albumin (< 35/≥35 g/L) | 20/112 | 14.3/23.4 | 1.627 (0.959–2.763) | 0.071 | ||||
Bilirubin (≥17/< 17 μmol/L) | 51/81 | 15.9/27.1 | 1.573 (1.045–2.368) | 0.030 | 1.397 (0.915–2.132) | 0.121 | 1.371 (0.878–2.139) | 0.165 |
AST (≥40/< 40 U/L) | 69/63 | 14.8/32.7 | 2.008 (1.329–3.034) | 0.001 | 1.859 (1.194–2.894) | 0.006 | 1.854 (1.193–2.883) | 0.006 |
ALT (≥40/< 40 U/L) | 56/76 | 17.1/21.7 | 0.943 (0.624–1.427) | 0.783 | ||||
AFP (≥200/< 200 ng/ml) | 67/65 | 15.7/28.7 | 1.533 (1.017–2.310) | 0.041 | 1.364 (0.869–2.142) | 0.178 | 1.379 (0.884–2.152) | 0.157 |
Ascites (with/without) | 15/117 | 12.6/21.9 | 1.975 (1.093–3.569) | 0.024 | 1.136 (0.470–2.764) | 0.777 | 1.149 (0.477–2.769) | 0.757 |
Child-Pugh score (5/6/≥7) | 104/20/8 | 25.1/17.1/12.5 | 1.606 (1.149–2.244) | 0.006 | 1.895 (1.150–3.123) | 0.012 | 1.907 (1.160–3.137) | 0.011 |
Tumor size (≥7/< 7 cm) | 71/61 | 16.5/26.3 | 1.457 (0.966–2.199) | 0.073 | ||||
No. of HCC nodules (≥2/1) | 63/69 | 14.8/27.1 | 1.806 (1.200–2.718) | 0.005 | 1.753 (1.134–2.709) | 0.012 | 1.764 (1.138–2.733) | 0.011 |
Sorafenib usage (after/before TACE) | 43/89 | 22.9/21.0 | 0.932 (0.608–1.430) | 0.747 | ||||
Vascularity (hypovascular/hypervascular) | 44/88 | 15.0/25.1 | 2.003 (1.300–3.085) | 0.002 | 2.103 (1.355–3.266) | 0.001 | ||
HFSR (non-responder/responder) | 60/72 | 15.0/25.1 | 1.801 (1.201–2.700) | 0.004 | 1.957 (1.281–2.991) | 0.002 | ||
Stratification | ||||||||
Group A | 52 | 29.1 | 1 | 1 | ||||
Group BC | 56 | 16.5 | 1.729 (1.085–2.758) | 0.021 | 1.910 (1.167–3.127) | 0.010 | ||
Group D | 24 | 11.9 | 3.166 (1.802–5.563) | < 0.001 | 4.154 (2.311–7.465) | < 0.001 |