A systematic review of sorafenib in child-pugh A patients with unresectable hepatocellular carcinoma

Journal of Clinical Gastroenterology

Volumn 47, Issue 10, 2013, Pages 871-880

  Shen, Ai ^a   Tang, Chengyong ^a   Wang, Yefei ^a   Chen, Yong ^a   Yan, Xiong ^a   Zhang, Chao ^a   Liu, Rui ^a   Wei, Xufu ^a   Zhu, Yiyun ^a   Zhang, Hua ^b   Wu, Zhongjun ^a  

^a THE FIRST AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY   (China)

^b People's Hospital of Changshou District   (China)

Author keywords

hepatocellular carcinoma; meta analysis; randomized controlled trial; sorafenib; systematic review

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA FETOPROTEIN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CHLOROTRIANISENE; DOXORUBICIN; PLACEBO; SORAFENIB;

ABDOMINAL PAIN; ALOPECIA; ANOREXIA; BLEEDING; CANCER MORTALITY; CANCER STAGING; CHILD PUGH SCORE; DESQUAMATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRY SKIN; FATIGUE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; LIVER CELL CARCINOMA; LIVER DYSFUNCTION; NAUSEA; OVERALL SURVIVAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; REVIEW; SIDE EFFECT; SYSTEMATIC REVIEW; TUMOR GROWTH; VOICE CHANGE; VOMITING; WEIGHT REDUCTION;

ADMINISTRATION, ORAL; ANTINEOPLASTIC AGENTS; CARCINOMA, HEPATOCELLULAR; DISEASE PROGRESSION; HUMANS; LIVER NEOPLASMS; NEOPLASM STAGING; NIACINAMIDE; PHENYLUREA COMPOUNDS; PROPORTIONAL HAZARDS MODELS; PROTEIN KINASE INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84886583796     PISSN: 01920790     EISSN: 15392031     Source Type: Journal    
DOI: 10.1097/MCG.0b013e3182a87cfd     Document Type: Review

References (57)

1. Parkin DM, Bray F, Ferlay J, et al. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55:74-108
2. Clavien PA, Petrowsky H, DeOliveira ML, et al. Strategies for safer liver surgery and partial liver transplantation. N Engl J Med. 2007;356:1545-1559
3. Cho YK, Kim JK, Kim MY, et al. Systematic review of randomized trials for hepatocellular carcinoma treated with percutaneous ablation therapies. Hepatology. 2009;49:453-459
4. Bruix J, Sherman M. Management of hepatocellular carcinoma: An update. Hepatology. 2011;53:1020-1022
5. Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003;37:429-442
6. Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/ MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64: 7099-7109
7. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356: 125-134
8. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378-390
9. 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 phase III randomised, doubleblind, placebo-controlled trial. Lancet Oncol. 2009;10:25-34
10. Kudo M, Imanaka K, Chida N, et al. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011;47:2117-2127
11. Choueiri TK, Schutz FA, Je Y, et al. Risk of arterial thromboembolic events with sunitinib and sorafenib: A systematic review and meta-analysis of clinical trials. J Clin Oncol. 2010;28:2280-2285
12. Je Y, Schutz FA, Choueiri TK. Risk of bleeding with vascular endothelial growth factor receptor tyrosine-kinase inhibitors sunitinib and sorafenib: A systematic review and meta-analysis of clinical trials. Lancet Oncol. 2009;10:967-974
13. Wu S, Chen JJ, Kudelka A, et al. Incidence and risk of hypertension with sorafenib in patients with cancer: A systematic review and meta-analysis. Lancet Oncol. 2008;9:117-123
14. Chu D, Lacouture ME, Fillos T, et al. Risk of hand-foot skin reaction with sorafenib: A systematic review and meta-analysis. Acta Oncol. 2008;47:176-186
15. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0 (updated March 2011). Available at: Http://www.cochrane-handbook.org, Accessed March 23, 2012
16. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med. 1998;17:2815-2834
17. Tierney JF, Stewart LA, Ghersi D, et al. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials. 2007;8:16
18. DerSimonian R, Kacker R. Random-effects model for metaanalysis of clinical trials: An update. Contemp Clin Trials. 2007;28:105-114
19. Spruance SL, Reid JE, Grace M, et al. Hazard ratio in clinical trials. Antimicrob Agents Chemother. 2004;48:2787-2792
20. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-560
21. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics. 1994;50: 1088-1101
22. Egger M, Davey Smith G, Schneider M, et al. Bias in metaanalysis detected by a simple, graphical test. BMJ. 1997;315: 629-634
23. Sansonno D, Lauletta G, Russi S, et al. Transarterial chemoembolization plus sorafenib: A sequential therapeutic scheme for HCV-related intermediate-stage hepatocellular carcinoma: A randomized clinical trial. Oncologist. 2012;17:359-366
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. JAMA. 2010;304:2154-2160
25. Bruix J, Raoul JL, Sherman M, et al. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma: Subanalyses of a phase III trial. J Hepatol. 2012;57:821-829
26. Cheng AL, Guan Z, Chen Z, et al. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012;48:1452-1465
27. Raoul J, Sherman M, Nadel A, et al. Efficacy and safety of sorafenib (Sor) in patients (Pts) with advanced hepatocellular carcinoma (HCC): Subgroup analyses of the SHARP trial by baseline (BL) transaminase (ALT/AST)/a- fetoprotein (AFP) and bilirubin (bil) levels. In: 2010 ASCO Annual Meeting Proceedings. J Clin Oncol. 2010;28(15 Suppl):Abstract 4051
28. Raoul JL, Bruix J, Greten TF, et al. Relationship between baseline hepatic status and outcome, and effect of sorafenib on liver function: SHARP trial subanalyses. J Hepatol. 2012;56: 1080-1088
29. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205-216
30. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649-655
31. Trotti A, Colevas AD, Setser A, et al. CTCAE v3.0: Development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003;13:176-181
32. Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012;379:1245-1255
33. Yuen MF, Hou JL, Chutaputti A. Hepatocellular carcinoma in the Asia pacific region. J Gastroenterol Hepatol. 2009;24:346-353
34. Farris AB III, Dursun N, Dhanasekaran R, et al. Tumoral and angiogenesis factors in hepatocellular carcinoma after locoregional therapy. Pathol Res Pract. 2012;208:15-21
35. Park JW, Koh YH, Kim HB, et al. Phase II study of concurrent transarterial chemoembolization and sorafenib in patients with unresectable hepatocellular carcinoma. J Hepatol. 2012;56:1336-1342
36. Pawlik TM, Reyes DK, Cosgrove D, et al. Phase II trial of sorafenib combined with concurrent transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma. J Clin Oncol. 2011;29:3960-3967
37. Lencioni R, Zou J, LeberreM, et al. Sorafenib (SOR) or placebo (PL) in combination with transarterial chemoembolization (TACE) for intermediate-stage hepatocellular carcinoma (SPACE). J Clin Oncol. 2010;28(15 Suppl):Abstract TPS178
38. Erhardt A, Kolligs FT, Dollinger M, et al. Sorafenib plus TACE for the treatment of advanced hepatocellular carcinoma - Final results of the SOCRATES trial. J Hepatol. 2011; 54(1 Suppl):Abstract 79
39. Miksad RA. Sorafenib therapy prior to radiofrequency ablation for intermediate sized hepatocellular cancer. Available at: Http://www. clinicaltrials.gov/ct2/show/NCT00813293. Accessed September 16, 2012
40. Pratt DS, Kaplan MM. Evaluation of abnormal liver-enzyme results in asymptomatic patients. N Engl J Med. 2000;342: 1266-1271
41. Astegiano M, Sapone N, Demarchi B, et al. Laboratory evaluation of the patient with liver disease. Eur Rev Med Pharmacol Sci. 2004;8:3-9
42. Field KM, Michael M, Part II. Liver function in oncology: Towards safer chemotherapy use. Lancet Oncol. 2008;9:1181-1190
43. Takamoto T, Hashimoto T, Sano K, et al. Recovery of liver function after the cessation of preoperative chemotherapy for colorectal liver metastasis. Ann Surg Oncol. 2010;17:2747-2755
44. Perkins GL, Slater ED, Sanders GK, et al. Serum tumor markers. Am Fam Physician. 2003;68:1075-1082
45. Noboru M, Souichi K, Tomoko D, et al. Clinical significance of a-fetoprotein: Involvement in proliferation, angiogenesis, and apoptosis of hepatocellular carcinoma. J Gastroenterol Hepatol. 2008;23:189-197
46. Shao YY, Lin ZZ, Hsu C, et al. Early alpha-fetoprotein response predicts treatment efficacy of antiangiogenic systemic therapy in patients with advanced hepatocellular carcinoma. Cancer. 2010;116:4590-4596
47. Zhang L, Zhou Q, Ma L, et al. Meta-analysis of dermatological toxicities associated with sorafenib. Clin Exp Dermatol. 2011;36:344-350
48. Robert C, Soria JC, Spatz A, et al. Cutaneous side-effects of kinase inhibitors and blocking antibodies. Lancet Oncol. 2005; 6:491-500
49. Worns MA, Weinmann A, Pfingst K, et al. Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma in consideration of concomitant stage of liver cirrhosis. J Clin Gastroenterol. 2009;43:489-495
50. Bozkurt Duman B, Kara B, Oguz Kara I, et al. Hand-foot syndrome due to sorafenib in hepatocellular carcinoma treated with vitamin E without dose modification; a preliminary clinical study. J BUON. 2011;16:759-764
51. Maitland ML, Kasza KE, Karrison T, et al. Ambulatory monitoring detects sorafenib-induced blood pressure elevations on the first day of treatment. Clin Cancer Res. 2009;15: 6250-6257
52. Mir O, Coriat R, Boudou-Rouquette P, et al. Sorafenibinduced diarrhea and hypophosphatemia: Mechanisms and therapeutic implications. Ann Oncol. 2012;23:280-281
53. Bellmunt J, Eisen T, Fishman M, et al. Experience with sorafenib and adverse event management. Crit Rev Oncol Hematol. 2011;78:24-32
54. Edmonds K, Hull D, Spencer-Shaw A, et al. Strategies for assessing and managing the adverse events of sorafenib and other targeted therapies in the treatment of renal cell and hepatocellular carcinoma: Recommendations from a European nursing task group. Eur J Oncol Nurs. 2012;16:172-184
55. Estfan B, Byrne M, Kim R. Sorafenib in advanced hepatocellular carcinoma hypertension as a potential surrogate marker for efficacy. Am J Clin Oncol. 2012;36:319-324
56. Bettinger D, Schultheiss M, Knuppel E, et al. Diarrhea predicts a positive response to sorafenib in patients with advanced hepatocellular carcinoma. Hepatology. 2012;56:789-790
57. Koschny R, Gotthardt D, Koehler C, et al. Diarrhea is a positive outcome predictor for sorafenib treatment of advanced hepatocellular carcinoma. Oncology. 2012;13:6-13