Copyright
©The Author(s) 2016.
World J Gastroenterol. Jun 21, 2016; 22(23): 5384-5392
Published online Jun 21, 2016. doi: 10.3748/wjg.v22.i23.5384
Published online Jun 21, 2016. doi: 10.3748/wjg.v22.i23.5384
Table 1 Patient demographics and tumor characteristics
Clinical parameter | Sorafenib | Control | P value2 |
No. of patients | 34 | 68 | - |
Males | 25 | 50 | - |
Age, yr1 | 48 (21-78) | 57 (18-79) | 0.142 |
Platelet count, 109/L1 | 121 (31-368) | 156 (30-317) | 0.046 |
Serum albumin, g/L1 | 38 (26-52) | 36 (24-51) | 0.387 |
Serum total bilirubin, mmol/L1 | 14.6 (5.1-48.3) | 16.4 (7.6-51.5) | 0.283 |
AST, IU/L1 | 56 (11-526) | 59 (12-498) | 0.525 |
Hemoglobin, g/L1 | 12.5 (6.6-18.6) | 11.5 (5.9-17.3) | 0.275 |
AFP ≥ 400, mg/L | 23 | 45 | 0.882 |
Hepatitis B virus infection | 29 (93.3%) | 59 (92.0%) | 0.692 |
ICG retention at 15 min, %1 | 7.7 (1.5-14.2) | 7.3 (2.3-13.8) | 0.482 |
Child–Pugh grade, A/B | 27/7 | 54/14 | - |
HBV DNA, > 1/ ≤ 1 × 105 copy/mL | 26/8 | 49/19 | 0.634 |
Prothrombin time, s1 | 14 (10-17) | 14 (10-19) | 0.224 |
Tumor size, cm1 | 6.4 (2.8-20.2) | 5.9 (2.9-21.3) | 0.098 |
Tumor number1 | 2 (1-8) | 2 (1-10) | 0.187 |
Hilar lymph nodes metastasis, yes/no | 11/23 | 29/39 | 0.315 |
Liver cirrhosis, yes/no | 30/4 | 60/8 | - |
ECOG performance status score, PS = 0/1 | 31/3 | 61/7 | 0.814 |
Median follow-up time, mo | 26 | 25 | - |
Table 2 Surgical outcomes
Variable | Sorafenib | Control | P value2 |
Type of resection | - | ||
Minor | 8 | 16 | |
Major3 | 26 | 52 | |
Intraoperative blood loss, mL1 | 350 (50-1600) | 380 (50-1800) | 0.132 |
Intraoperative blood transfusion, mL1 | 650 (0-1500) | 600 (0-1600) | 0.126 |
No. of patients without transfusion, % | 31 (75.0%) | 58 (81.48%) | 0.139 |
Postoperative AST on day 3, IU/L1 | 226 (48-896) | 327 (68-1237) | 0.042 |
Postoperative total bilirubin on day 3, mmol/L1 | 42 (19-276) | 39 (18-212) | 0.138 |
Infectious morbidity | 8 | 12 | 0.566 |
Lung infection | 3 | 4 | |
Abdominal collection | 4 | 6 | |
Infection of incisional wound | 1 | 1 | |
Sepsis | 0 | 1 | |
Noninfectious morbidity | 4 | 9 | 0.853 |
Pleural effusion | 3 | 5 | |
Bile leak | 1 | 4 | |
Liver failure | 0 | 0 |
Table 3 Type of recurrence
Type of recurrence | Sorafenib | Control | P value1 |
Hepatic | 8 | 28 | 0.079 |
Extrahepatic | 5 | 12 | 0.707 |
Hepatic + extrahepatic | 2 | 11 | 0.142 |
Overall hepatic recurrence | 10 | 39 | 0.008 |
Overall extrahepatic | 7 | 23 | 0.167 |
Total recurrence | 15 (44.1%) | 51 (75.0%) | 0.002 |
Table 4 Univariate and multivariate analyses of potential risk factors of tumor recurrence
Risk factors1 | Univariate analysis | Multivariate analysis | ||||
Hazard ratio | 95%CI | P value(Cox’s regression) | Hazard ratio | 95%CI | P value(Cox’s regression) | |
Sex, male/female | 1.159 | 1.934-1.402 | 0.118 | |||
Age, > 50/ ≤ 50 yr | 1.003 | 0.961-1.012 | 0.751 | |||
Platelet count, > 100/ ≤ 100 × 109/L | 1.258 | 0.939-1.626 | 0.095 | |||
Hemoglobin, > 10/ ≤ 10 g/L | 1.119 | 0.867-1.411 | 0.089 | |||
Serum AFP, > 400/ ≤ 400 ng/mL | 0.960 | 0.929-1.011 | 0.079 | |||
HBV infection, yes/no | 0.931 | 0.593-1.449 | 0.769 | |||
HBV DNA, > 1/ ≤ 1 × 105 copy/mL | 1.323 | 0.912-1.883 | 0.119 | |||
AST, > 42/ ≤ 42 IU/L | 1.171 | 0.933-1.425 | 0.127 | |||
Serum albumin, > 38/ ≤ 38 g/L | 1.264 | 0.961-1.665 | 0.095 | |||
Serum total bilirubin, > 21/ ≤ 21 mmol/L | 0.965 | 0.923-1.010 | 0.075 | |||
Prothrombin time, > 12.8/ ≤ 12.8 s | 1.162 | 0.931-1.324 | 0.126 | |||
ICG retention at 15 min, > 10%/ ≤ 10% | 1.349 | 0.903-1.989 | 0.115 | |||
Child-Pugh grade, A/B | 1.011 | 0.914-1.097 | 0.779 | |||
Tumor size, > 50/ ≤ 50 mm | 0.957 | 0.904-1.014 | 0.075 | |||
HBsAg, positive/negative | 1.241 | 0.948-1.649 | 0.094 | |||
HBeAg, positive/negative | 1.174 | 0.938-1.422 | 0.121 | |||
Type of resection, minor/major | 1.131 | 0.949-1.381 | 0.086 | |||
Tumor number, < 3/≥ 3 | 2.050 | 1.051-3.549 | 0.034 | 1.324 | 1.035-1.776 | 0.045 |
Macrovascular invasion, yes/no | 1.242 | 1.061-1.501 | 0.035 | |||
Hilar lymph nodes metastasis, yes/no | 1.058 | 1.006-1.111 | 0.043 | |||
Sorafenib, yes/no | 1.012 | 1.003-1.099 | 0.034a | 1.353 | 1.012-1.763 | 0.039 |
Table 5 Comparison of outcomes of patients with Barcelona Clinic Liver Cancer-stage C hepatocellular carcinoma treated by various interventions
Study | Year | Number of patients | Interventions | Median OS, mo | 1-, 3-, 5-yr | |
DFS, % | OS, % | |||||
Llovet et al[9] | 2008 | 299 | Sorafenib | 10.7 | - | 44/-/-1 |
303 | Placebo | 7.9 | - | 33/-/- | ||
Cheng et al[22] | 2009 | 150 | Sorafenib | 6.5 | - | 53.3/-/-1 |
76 | Placebo | 4.2 | - | 36.7/-/-1 | ||
Wörns et al[23] | 2009 | 22 | Sorafenib | 3.3 | - | - |
Yau et al[24] | 2009 | 51 | Sorafenib | 5.0 | - | - |
Ozenne et al[25] | 2010 | 50 | Sorafenib | 5.5 | - | - |
Baek et al[26] | 2011 | 201 | Sorafenib | 5.3 | - | - |
Iavarone et al[27] | 2011 | 296 | Sorafenib | 10.51 | ||
Santini et al[28] | 2012 | 93 | Sorafenib | 12.01 | ||
Zhao et al[29] | 2013 | 222 | Sorafenib and TACE | 12.01 | ||
Minagawa et al[30] | 2001 | 18 | Liver resection | 82/42/42 | ||
Chirica et al[31] | 2008 | 20 | Liver resection | 32.0 | 40/20/171 | 73/56/451 |
Ishizawa et al[32] | 2008 | 98 | Liver resection | -/37/25 | -/71/56 | |
Wang et al[33] | 2008 | 14 | Liver resection | 13.0 | 57/29/29 | |
Torzilli et al[34] | 2008 | 28 | Liver resection | 66/17/- | 80/74/- | |
Yang et al[35] | 2012 | 511 | Liver resection | 27.8 | 48/30/24 | 70/41/31 |
Torzilli et al[10] | 2013 | 297 | Liver resection | 46/28/18 | 76/49/38 | |
This study | 2014 | 68 | Liver resection | 18.0 | 42/26/- | 69/34/- |
34 | Liver resection and Sorafenib | 25.0 | 63/37/- | 88/53/- |
- Citation: Xia F, Wu LL, Lau WY, Huan HB, Wen XD, Ma KS, Li XW, Bie P. Adjuvant sorafenib after heptectomy for Barcelona Clinic Liver Cancer-stage C hepatocellular carcinoma patients. World J Gastroenterol 2016; 22(23): 5384-5392
- URL: https://www.wjgnet.com/1007-9327/full/v22/i23/5384.htm
- DOI: https://dx.doi.org/10.3748/wjg.v22.i23.5384