Effect and Safety of Sorafenib in Advanced Hepaotocellular Carcinoma: a Systematic Review_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

 YIPeng-sheng , ZHANGMing ,  XUMing-qing

Department of Liver Surgery, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China;

Corresponding author：

XUMing-qing, Email: xumingqing@163.com

Keywords：

Sorafenib; Advanced hepatocellular carcinoma; Effect; Safety; Meta analysis

DOI：

10.7507/1007-9424.20140303

Video：

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Objective To evaluate the effect and safety of sorafenib in patients with advanced hepatocellular carcinoma(HCC). Methods The computer-based search in Pubmed, Embase, Science Citation Index, and Cochrane for phaseⅡandⅢclinical trial related to sorafeinib in advanced HCC were conducted. Data abstraction and quality assessment were conducted according to enrolled criteria. Meta-analysis was performed by REVMAN 5.2 version, evidence recommendation was conducted by GRADE 3.6 version, which classify evidence level into:extremely low quality evidence, low quality evidence, moderate quality evidence, and high quality evidence. Results Five studies were included, 4 randomization control trial(RCT), 1 prospective no-randomization control clinical trial. Meta-analysis indicated that overall survival, time to progression, and disease control rate in sorafenib treatment group were higher than those in control group(P < 0.05). In addition, the incidence of hand-foot skin reaction, rash/desquamation, hypertention, and dirrahea in soafeinib treatment group were higher than those in control group(P < 0.05). Conclusion Sorafeinib can prolong the overall survival, time to progression, and disease control rate in patients with advanced HCC, but there is still no evidence that sorafenib can improve tumor response in these patients.

Citation： YIPeng-sheng, ZHANGMing, XUMing-qing. Effect and Safety of Sorafenib in Advanced Hepaotocellular Carcinoma: a Systematic Review. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2014, 21(10): 1268-1276. doi: 10.7507/1007-9424.20140303 Copy

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2.	Murata S, Mine T, Ueda T, et al. Transcatheter arterial chemoembolization based on hepatic hemodynamics for hepatocellular carcinoma[J]. Scientific World J, 2013, 2013:479805.
3.	Varga M, Valsamis A, Matia I, et al. Transarterial chemoembolization in hepatocellular carcinoma[J]. Rozhl Chir, 2009, 88(8):434-438.
4.	Biolato M, Marrone G, Racco S, et al. Transarterial chemoembolization (TACE) for unresectable HCC:a new life begins?[J]. Eur Rev Med Pharmacol Sci, 2010, 14(4):356-362.
5.	Duan F, Wang MQ, Liu FY, et al. Sorafenib in combination with transarterial chemoembolization and bronchial arterial chemoinfusion in the treatment of hepatocellular carcinoma with pulmonary metastasis[J]. Asia Pac J Clin Oncol, 2012, 8(2):156-163.
6.	Llovet JM, Bruix J. Molecular targeted therapies in hepatocellular carcinoma[J]. Hepatology, 2008, 48(4):1312-1327.
7.	Furuse J. Sorafenib for the treatment of unresectable hepatocellular carcinoma[J]. Biologics, 2008, 2(4):779-788.
8.	Personeni N, Rimassa L, Pressiani T, et al. Molecular determinants of outcome in sorafenib-treated patients with hepatocellular carcinoma[J]. J Cancer Res Clin Oncol, 2013, 139(7):1179-1187.
9.	Zhu AX. Molecularly targeted therapy for advanced hepatocellular carcinoma in 2012:current status and future perspectives[J]. Semin Oncol, 2012, 39(4):493-502.
10.	Tanaka S, Arii S. Molecular targeted therapies in hepatocellular carcinoma[J]. Semin Oncol, 2012, 39(4):486-492.
11.	Zhang X, Yang XR, Huang XW, et al. Sorafenib in treatment of patients with advanced hepatocellular carcinoma:a systematic review[J]. Hepatobiliary Pancreat Dis Int, 2012, 11(5):458-466.
12.	Zhang T, Ding X, Wei D, et al. Sorafenib improves the survival of patients with advanced hepatocellular carcinoma:a meta-analysis of randomized trials[J]. Anticancer Drugs, 2010, 21(3):326-332.
13.	Connock M, Round J, Bayliss S, et al. Sorafenib for the treatment of advanced hepatocellular carcinoma[J]. Health Technol Assess, 2010, 14 Suppl 1:17-21.
14.	Abdel-Rahman O, Elsayed ZA. Combination trans arterial chemoembolization (TACE) plus sorafenib for the management of unresectable hepatocellular carcinoma:a systematic review of the literature[J]. Dig Dis Sci, 2013, 58(12):3389-3396.
15.	Shen A, Tang C, Wang Y, et al. A systematic review of sorafenib in child-pugh a patients with unresectable hepatocellular carcinoma[J]. J Clin Gastroenterol, 2013, 47(10):871-880.
16.	Trojniak MP, Palozzo AC, Mazurek M, et al. Sorafenib in hepatocellular carcinoma-a post marketing evaluation[J]. Immunopharmacol Immunotoxicol, 2012, 34(3):419-422.
17.	Nakano M, Tanaka M, Kuromatsu R, et al. Efficacy, safety, and survival factors for sorafenib treatment in Japanese patients with advanced hepatocellular carcinoma[J]. Oncology, 2013, 84(2):108-114.
18.	胡安斌, 何晓顺, 邰强, 等.索拉非尼在预防和治疗肝癌肝移植术后肿瘤复发中的疗效评价[J].中华医学杂志, 2012, 92(18):1264-1267.
19.	Bruix J, Raoul JL, Sherman M, et al. Efficacy and safety of sora-fenib in patients with advanced hepatocellular carcinoma:subanal-yses of a phaseⅢtrial[J]. J Hepatol, 2012, 57(4):821-829.
20.	Jang RW, Caraiscos VB, Swami N, et al. Simple prognostic model for patients with advanced cancer based on performance status[J]. J Oncol Pract, 2014, 10(5):e335-e341.
21.	Brunetti M, Shemilt I, Pregno S, et al. GRADE guidelines:10.Considering resource use and rating the quality of economic evidence[J]. J Clin Epidemiol, 2013, 66(2):140-150.
22.	Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma[J]. N Engl J Med, 2008, 359(4):378-390.
23.	Cheng AL, Kang YK, Chen Z, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma:a phaseⅢrandomised, double-blind, placebo-controlled trial[J]. Lancet Oncol, 2009, 10(1):25-34.
24.	Abou-Alfa GK, Johnson P, Knox JJ, et al. Doxorubicin plus sorafenib vs doxorubicin alone in patients with advanced hepatocellular carcinoma:a randomized trial[J]. JAMA, 2010, 304(19):2154-2160.
25.	Kudo M, Imanaka K, Chida N, et al. PhaseⅢstudy of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma[J]. Eur J Cancer, 2011, 47(14):2117-2127.
26.	Bai W, Wang YJ, Zhao Y, et al. Sorafenib in combination with transarterial chemoembolization improves the survival of patients with unresectable hepatocellular carcinoma:a propensity score matching study[J]. J Dig Dis, 2013, 14(4):181-190.
27.	曾宪涛, 冷卫东, 李胜, 等.如何正确理解及使用GRADE系统[J].中国循证医学杂志, 2011, 11(9):985-990.
28.	皋文君, 刘砚燕, 袁长蓉.国际肿瘤化疗药物不良反应评价系统——通用不良反应术语标准4.0版[J].肿瘤, 2012, 32(2):142-144.
29.	张岚, 任正刚.索拉菲尼治疗肝癌常见不良反应及处理的研究进展[J].中国肿瘤临床, 2013, 40(20):1268-1271.

1. Qu XD, Chen CS, Wang JH, et al. The efficacy of TACE combined sorafenib in advanced stages hepatocellullar carcinoma[J]. BMC Cancer, 2012, 12:263.
2. Murata S, Mine T, Ueda T, et al. Transcatheter arterial chemoembolization based on hepatic hemodynamics for hepatocellular carcinoma[J]. Scientific World J, 2013, 2013:479805.
3. Varga M, Valsamis A, Matia I, et al. Transarterial chemoembolization in hepatocellular carcinoma[J]. Rozhl Chir, 2009, 88(8):434-438.
4. Biolato M, Marrone G, Racco S, et al. Transarterial chemoembolization (TACE) for unresectable HCC:a new life begins?[J]. Eur Rev Med Pharmacol Sci, 2010, 14(4):356-362.
5. Duan F, Wang MQ, Liu FY, et al. Sorafenib in combination with transarterial chemoembolization and bronchial arterial chemoinfusion in the treatment of hepatocellular carcinoma with pulmonary metastasis[J]. Asia Pac J Clin Oncol, 2012, 8(2):156-163.
6. Llovet JM, Bruix J. Molecular targeted therapies in hepatocellular carcinoma[J]. Hepatology, 2008, 48(4):1312-1327.
7. Furuse J. Sorafenib for the treatment of unresectable hepatocellular carcinoma[J]. Biologics, 2008, 2(4):779-788.
8. Personeni N, Rimassa L, Pressiani T, et al. Molecular determinants of outcome in sorafenib-treated patients with hepatocellular carcinoma[J]. J Cancer Res Clin Oncol, 2013, 139(7):1179-1187.
9. Zhu AX. Molecularly targeted therapy for advanced hepatocellular carcinoma in 2012:current status and future perspectives[J]. Semin Oncol, 2012, 39(4):493-502.
10. Tanaka S, Arii S. Molecular targeted therapies in hepatocellular carcinoma[J]. Semin Oncol, 2012, 39(4):486-492.
11. Zhang X, Yang XR, Huang XW, et al. Sorafenib in treatment of patients with advanced hepatocellular carcinoma:a systematic review[J]. Hepatobiliary Pancreat Dis Int, 2012, 11(5):458-466.
12. Zhang T, Ding X, Wei D, et al. Sorafenib improves the survival of patients with advanced hepatocellular carcinoma:a meta-analysis of randomized trials[J]. Anticancer Drugs, 2010, 21(3):326-332.
13. Connock M, Round J, Bayliss S, et al. Sorafenib for the treatment of advanced hepatocellular carcinoma[J]. Health Technol Assess, 2010, 14 Suppl 1:17-21.
14. Abdel-Rahman O, Elsayed ZA. Combination trans arterial chemoembolization (TACE) plus sorafenib for the management of unresectable hepatocellular carcinoma:a systematic review of the literature[J]. Dig Dis Sci, 2013, 58(12):3389-3396.
15. Shen A, Tang C, Wang Y, et al. A systematic review of sorafenib in child-pugh a patients with unresectable hepatocellular carcinoma[J]. J Clin Gastroenterol, 2013, 47(10):871-880.
16. Trojniak MP, Palozzo AC, Mazurek M, et al. Sorafenib in hepatocellular carcinoma-a post marketing evaluation[J]. Immunopharmacol Immunotoxicol, 2012, 34(3):419-422.
17. Nakano M, Tanaka M, Kuromatsu R, et al. Efficacy, safety, and survival factors for sorafenib treatment in Japanese patients with advanced hepatocellular carcinoma[J]. Oncology, 2013, 84(2):108-114.
18. 胡安斌, 何晓顺, 邰强, 等.索拉非尼在预防和治疗肝癌肝移植术后肿瘤复发中的疗效评价[J].中华医学杂志, 2012, 92(18):1264-1267.
19. Bruix J, Raoul JL, Sherman M, et al. Efficacy and safety of sora-fenib in patients with advanced hepatocellular carcinoma:subanal-yses of a phaseⅢtrial[J]. J Hepatol, 2012, 57(4):821-829.
20. Jang RW, Caraiscos VB, Swami N, et al. Simple prognostic model for patients with advanced cancer based on performance status[J]. J Oncol Pract, 2014, 10(5):e335-e341.
21. Brunetti M, Shemilt I, Pregno S, et al. GRADE guidelines:10.Considering resource use and rating the quality of economic evidence[J]. J Clin Epidemiol, 2013, 66(2):140-150.
22. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma[J]. N Engl J Med, 2008, 359(4):378-390.
23. Cheng AL, Kang YK, Chen Z, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma:a phaseⅢrandomised, double-blind, placebo-controlled trial[J]. Lancet Oncol, 2009, 10(1):25-34.
24. Abou-Alfa GK, Johnson P, Knox JJ, et al. Doxorubicin plus sorafenib vs doxorubicin alone in patients with advanced hepatocellular carcinoma:a randomized trial[J]. JAMA, 2010, 304(19):2154-2160.
25. Kudo M, Imanaka K, Chida N, et al. PhaseⅢstudy of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma[J]. Eur J Cancer, 2011, 47(14):2117-2127.
26. Bai W, Wang YJ, Zhao Y, et al. Sorafenib in combination with transarterial chemoembolization improves the survival of patients with unresectable hepatocellular carcinoma:a propensity score matching study[J]. J Dig Dis, 2013, 14(4):181-190.
27. 曾宪涛, 冷卫东, 李胜, 等.如何正确理解及使用GRADE系统[J].中国循证医学杂志, 2011, 11(9):985-990.
28. 皋文君, 刘砚燕, 袁长蓉.国际肿瘤化疗药物不良反应评价系统——通用不良反应术语标准4.0版[J].肿瘤, 2012, 32(2):142-144.
29. 张岚, 任正刚.索拉菲尼治疗肝癌常见不良反应及处理的研究进展[J].中国肿瘤临床, 2013, 40(20):1268-1271.

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Effect and Safety of Sorafenib in Advanced Hepaotocellular Carcinoma: a Systematic Review

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