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

European Journal of Cancer

Volumn 48, Issue 10, 2012, Pages 1452-1465

  Cheng, Ann Lii ^a   Guan, Zhongzhen ^b   Chen, Zhendong ^c   Tsao, Chao Jung ^d   Qin, Shukui ^e   Kim, Jun Suk ^f   Yang, Tsai Sheng ^g   Tak, Won Young ^h   Pan, Hongming ⁱ   Yu, Shiying ^j   Xu, Jianming ^k   Fang, Fang ^l   Zou, Jessie ^l   Lentini, Giuseppe ^m   Voliotis, Dimitris ^l   Kang, Yoon Koo ⁿ  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^c ANHUI MEDICAL UNIVERSITY   (China)

^d Chi Mei Medical Centre   (Taiwan)

^e Nanjing Bayi Hospital   (China)

^f Korea University College of Medicine   (South Korea)

^g CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^h Kyungpook National University Hospital   (South Korea)

ⁱ ZHEJIANG UNIVERSITY   (China)

^j HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY   (China)

^k BEIJING INSTITUTE OF MICROBIOLOGY AND EPIDEMIOLOGY   (China)

^l BAYER CORPORATION   (United States)

^m BAYER PHARMA AG   (Germany)

ⁿ Asan Medical Center   (South Korea)

more..

Author keywords

Hepatocellular carcinoma; Sorafenib; Subset analyses

Indexed keywords

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

ADULT; ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CHEMOEMBOLIZATION; CHINA; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; LIVER CELL CARCINOMA; LIVER FUNCTION; LUNG METASTASIS; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MALE; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; SOUTH KOREA; TAIWAN;

ADULT; BENZENESULFONATES; CARCINOMA, HEPATOCELLULAR; CHINA; FEMALE; HUMANS; LIVER NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PLACEBOS; PROGNOSIS; PYRIDINES; REPUBLIC OF KOREA; TAIWAN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84862776817     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2011.12.006     Document Type: Article

References (34)

1. J. Ferlay, H.R. Shin, and F. Bray Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008 Int J Cancer 127 2010 2893 2917
2. P. Srivatanakul, H. Sriplung, and S. Deerasamee Epidemiology of liver cancer: an overview Asian Pac J Cancer Prev 5 2004 118 125
3. M.C. Kew Epidemiology of chronic hepatitis B virus infection, hepatocellular carcinoma, and hepatitis B virus-induced hepatocellular carcinoma Pathol Biol (Paris) 58 2010 273 277
4. S.M. Wilhelm, C. Carter, and L. Tang BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/MERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis Cancer Res 64 2004 7099 7109
5. S.M. Wilhelm, L. Adnane, and P. Newell Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF amd PDGF receptor tyrosine kinase signaling Mol Cancer Ther 7 2008 3129 3140
6. H. Huynh, T.T. Nguyen, and K.H. Chow Over-expression of the mitogen-activated protein kinase (MAPK) kinase (MEK)-MAPK in hepatocellular carcinoma: its role in tumor progression and apoptosis BMC Gastroenterol 3 2003 19
7. T. Yoshida, T. Hisamoto, and J. Akiba Spreds, inhibitors of the Ras/ERK signal transduction, are dysregulated in human hepatocellular carcinoma and linked to the malignant phenotype of tumors Oncogene 25 2006 6056 6066
8. R.T. Poon, C. Lau, and R. Pang High serum vascular endothelial growth factor levels predict poor prognosis after radiofrequency ablation of hepatocellular carcinoma: importance of tumor biomarker in ablative therapies Ann Surg Oncol 14 2007 1835 1845
9. H. Wada, H. Nagano, and H. Yamamoto Expression pattern of angiogenic factors and prognosis after hepatic resection in hepatocellular carcinoma: importance of angiopoietin-2 and hypoxia-induced factor-1 alpha Liver Int 26 2006 414 423
10. P. Stock, D. Monga, and X. Tan Platelet-derived growth factor receptor-alpha: a novel therapeutic target in human hepatocellular carcinoma Mol Cancer Ther 6 2007 1932 1941
11. L. Liu, Y. Cao, and C. Chen Sorafenib blocks the RAF/MEK/ERK pathway, inhibits tumor angiogenesis, and induces tumor cell apoptosis in hepatocellular carcinoma model PLC/PRF/5 Cancer Res 66 2006 11851 11858
12. J.M. Llovet, S. Ricci, and V. Mazzaferro Sorafenib in advanced hepatocellular carcinoma N Engl J Med 359 2008 378 390
13. Bolondi L, Caspary W, Bennouna J, et al. Clinical benefit of sorafenib in hepatitis C patients with hepatocellular carcinoma (HCC): subgroup analysis of the SHARP trial. Presented at: American Society of Clinical Oncology Gastrointestinal Cancers Symposium, January 25-28, 2008; Orlando, Florida, USA. [abstract 129].
14. Galle P, Blanc J, Van Laethem, et al. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma and prior anti-tumor therapy: a subanalysis from the SHARP trial. J Hepatol 2008;48(Suppl.):S372 [abstract 994].
15. Sherman M, Mazzaferro V, Amadori D, et al. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma and vascular invasion or extrahepatic spread: a subanalysis from the SHARP trial J Clin Oncol 2008;26(Suppl.):[abstract 4584].
16. Raoul J, Santoro A, Beaugrand M, et al. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to ECOG performance status: a subanalysis from the SHARP trial. J Clin Oncol 2008;26(Suppl.): [abstract 4587].
17. Craxi A, Porta C, Sangiovanni A, et al. Efficacy and safety of sorafenib in patients with alcohol-related hepatocellular carcinoma: a subanalysis from the SHARP trial. J Clin Oncol 2008;26(Suppl):[abstract 15591].
18. Bruix J, Raoul JL, Sherman M, et al. Efficacy and safety of sorafenib in patients with hepatocellular carcinoma (HCC): subanalysis of SHARP trial based on Barcelona Clinic Liver Cancer (BCLC) stage. J Hepatol 2009;50(Suppl.):S28-9 [abstract 67].
19. A.L. Cheng, Y.K. Kang, and Z. Chen Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial Lancet Oncol 10 2009 25 34
20. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer 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 92 2000 205 216
21. National Cancer Institute. Common terminology for adverse events v3.0 (CTCAE);2006. Available from: http://ctep.cancer.gov/protocoldevelopment/ electronic-applications/docs/ctcaev3.pdf. [Accessed 5th February 2011].
22. X. Ding, Y.N. Park, and T.C. Taltavull Geographic characterization of hepatitis virus infections, genotyping of hepatitis B virus, and p53 mutation in hepatocellular carcinoma analyzed by in situ detection of viral genomes from carcinoma tissues: comparison among six different countries Jpn J Infect Dis 56 2003 12 18
23. W.T. London, A.A. Evans, and K. McGlynn Viral, host, and environmental risk factors for hepatocellular carcinoma: a prospective study in Haimen City, China Intervirology 38 1995 155 161
24. F.S. Yeh, M.C. Yu, and C.C. Mo Hepatitis B virus, aflatoxins, and hepatocellular carcinoma in southern Guangxi, China Cancer Res 49 1989 2506 2509
25. Y.P. Yeung, C.M. Lo, and C.L. Liu Natural history of untreated nonsurgical hepatocellular carcinoma Am J Gastroenterol 100 2005 1995 2004
26. K. Dohmen Many staging systems for hepatocellular carcinoma: evolution from Child-Pugh, Okuda to SLiDe J Gastroenterol Hepatol 19 2004 1227 1232
27. J.A. Marrero, R.J. Fontana, and A. Barrat Prognosis of hepatocellular carcinoma: comparison of 7 staging systems in an American cohort Hepatology 41 2005 707 716
28. P. Ferenci, M. Fried, and D. Labrecque World Gastroenterology Organisation Guideline. Hepatocellular carcinoma (HCC): a global perspective J Gastrointest Liver Dis 19 2010 311 317
29. D.S. Pratt, and M.M. Kaplan Evaluation of abnormal liver-enzyme results in asymptomatic patients N Engl J Med 342 2000 1266 1271
30. H.J. Kim, S.W. Oh, D.J. Kim, and E.Y. Choi Abundance of immunologically active alanine aminotransferase in sera of liver cirrhosis and hepatocellular carcinoma patients Clin Chem 55 2009 1022 1025
31. P.J. Johnson The role of serum alpha-fetoprotein estimation in the diagnosis and management of hepatocellular carcinoma Clin Liver Dis 5 2001 145 159
32. O. Arrieta, B. Cacho, and D. Morales-Espinosa The progressive elevation of alpha fetoprotein for the diagnosis of hepatocellular carcinoma in patients with liver cirrhosis BMC Cancer 7 2007 28
33. J.K. Limdi, and G.M. Hyde Evaluation of abnormal liver function tests Postgrad Med J 79 2003 307 312
34. Raoul JL, 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)/α- fetoprotein (AFP) and bilirubin (bil) levels. J Clin Oncol 2010;28(Suppl.): [abstract 4051].