Sorafenib therapy in advanced hepatocellular carcinoma: the SHARP trial

References

• El-Serag HB, Rudolph KL. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology132(7), 2557–2576 (2007).
   PubMed Web of Science ®Google Scholar
• Lopez PM, Villanueva A, Llovet JM. Systematic review: evidence-based management of hepatocellular carcinoma – an updated analysis of randomized controlled trials. Aliment. Pharmacol. Ther.23(11), 1535–1547 (2006).
   PubMed Web of Science ®Google Scholar
• Villanueva A, Newell P, Chiang DY, Friedman SL, Llovet JM. Genomics and signaling pathways in hepatocellular carcinoma. Semin. Liver Dis.27(1), 55–76 (2007).
   PubMed Web of Science ®Google Scholar
• Semela D, Dufour JF. Angiogenesis and hepatocellular carcinoma. J. Hepatol.41(5), 864–880 (2004).
   PubMed Web of Science ®Google Scholar
• Llovet JM, Bruix J. Molecular targeted therapies in hepatocellular carcinoma. Hepatology48(4), 1312–1327 (2008).
   PubMed Web of Science ®Google Scholar
• Greten TF, Korangy F, Manns MP, Malek NP. Molecular therapy for the treatment of hepatocellular carcinoma. Br. J. Cancer.100(1), 19–23 (2009).
   PubMed Web of Science ®Google Scholar
• Tanaka S, Arii S. Molecularly targeted therapy for hepatocellular carcinoma. Cancer Sci.100(1), 1–8 (2009).
   PubMedGoogle Scholar
• 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.64(19), 7099–7109 (2004).
   PubMed Web of Science ®Google Scholar
• Chang YS, Adnane J, Trail PA et al. Sorafenib (BAY 43-9006) inhibits tumor growth and vascularization and induces tumor apoptosis and hypoxia in RCC xenograft models. Cancer Chemother. Pharmacol.59(5), 561–574 (2007).
   PubMed Web of Science ®Google Scholar
• Liu L, Cao Y, Chen C et al. 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(24), 11851–11858 (2006).
   PubMed Web of Science ®Google Scholar
• Strumberg D, Richly H, Hilger RA et al. Phase I clinical and pharmacokinetic study of the novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J. Clin. Oncol.23(5), 965–972 (2005).
   PubMed Web of Science ®Google Scholar
• Abou-Alfa GK, Schwartz L, Ricci S et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J. Clin. Oncol.24(26), 4293–4300 (2006).
   PubMed Web of Science ®Google Scholar
• Llovet JM, Ricci S, Mazzaferro V et al. Sorafenib in advanced hepatocellular carcinoma. N. Engl. J. Med.359(4), 378–390 (2008).
   PubMed Web of Science ®Google Scholar
• 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, double-blind, placebo-controlled trial. Lancet Oncol.10(1), 25–34 (2009).
   PubMed Web of Science ®Google Scholar
• Abou-Alfa G, Johnson P, Knox J et al. Final results from a Phase II (PhII), randomized, double-blind, study of sorafenib plus doxorubicin (S+D) versus placebo plus doxorubicin (P+D) in patients (pts) with advanced hepatocellular carcinoma (AHCC). Presented at: 2008 Gastrointestinal Cancer Symposium. FL, USA, 25–27 January 2008 (Abstract 128).
   Google Scholar
• Keating GM, Santoro A. Sorafenib. A review of its use in hepatocellular carcinoma. Drugs69(2), 223–240 (2009).
   PubMed Web of Science ®Google Scholar
• Llovet JM, Peña C, Shan M, Jeffers M, Lathia C, Bruix J. Biomarkers predicting outcome of patients with hepatocellular carcinoma: results from the randomized Phase III SHARP trial. Presented at: The 59th Annual Meeting of the American Association for the Study of Liver Diseases. CA, USA, 31 October–4 November 2008 (Abstract 149).
   Google Scholar
• Kelley RK, Venook AP. Sorafenib in hepatocellular carcinoma: separating the hype from the hope. J. Clin. Oncol.26(36), 5845–5848 (2008).
   PubMedGoogle Scholar
• 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: 2008 Gastrointestinal Cancer Symposium. Orlando, FL, USA, 25–27 January 2008 (Abstract 129).
   Google Scholar
• Guan Z, Kang YK, Chen Z et al. Sorafenib is effective in hepatitis-B positive patients with hepatocellular carcinoma (HCC): subgroup analysis of a randomized, double-blind, Phase III trial performed in the Asia–Pacific region. Presented at: 33rd ESMO Congress. Stockholm, Sweden, 12–16 September 2008 (Abstract 512PD).
   Google Scholar
• Galle P, Blanc J, Van Laethem JL et al. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma and prior anti-tumor therapy: a subanalysis from the SHARP trial. Presented at: 43rd Annual Meeting of the European Association for the Study of the Liver. Milan, Italy, 23–27 April 2008 (Abstract 994).
   Google Scholar
• 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. Presented at: 44th Annual Meeting of the American Society of Clinical Oncology. IL, USA, 30 May–3 Jun 2008 (Abstract 4587).
   Google Scholar
• Kang YK, Guan Z, Chen Z et al. Sorafenib is effective in patients from the Asia–Pacific region with hepatocellular carcinoma (HCC): subgroup analysis of effect of macroscopic vascular invasion, extrahepatic spread, and ECOG performance status on outcome. Presented at: The 59th Annual Meeting of the American Association for the Study of Liver Diseases. CA, USA, 31 October–4 November 2008 (Abstract 1505).
   Google Scholar
• Greten T, Scherübl J, Scheulen M et al. Baseline transaminase levels and efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma (HCC): a subgroup analysis of SHARP. Presented at: 2008 Gastrointestinal Cancer Symposium. FL, USA, 25–27 January 2008 (Abstract 197).
   Google Scholar
• 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. Presented at: 44th Annual Meeting of the American Society of Clinical Oncology. Chicago, IL, USA, 30 May–3 June 2008 (Abstract 15591).
   Google Scholar
• Abou-Alfa GK, Amadori D, Santoro A et al. Is sorafenib (S) safe and effective in patients (pts) with hepatocellular carcinoma (HCC) and Child-Pugh B (CPB) cirrhosis? Presented at: 44th Annual Meeting of the American Society of Clinical Oncology. Chicago, IL, USA, 30 May–3 June 2008 (Abstract 4518).
   Google Scholar
• Weinmann A, Schrabback P, Schulze-Bergkamen H et al. a-feto-protein levels during treatment with sorafenib in patients with advanced hepatocellular carcinoma. Presented at: 43rd Annual Meeting of the European Association for the Study of the Liver. Milan, Italy, 23–27 April 2008 (Abstract 417).
   Google Scholar
• Siemerink E, Mulder NH, Brouwers AH, Hospers GA. Early prediction of response to sorafenib treatment in patients with hepatocellular carcinoma with 18F-fluorodeoxyglucose–positron emission tomography. Presented at: 44th Annual Meeting of the American Society of Clinical Oncology. IL, USA, 30 May–3 June 2008 (Abstract 15600).
   Google Scholar
• Galle PR. Sorafenib in advanced hepatocellular carcinoma – we have won a battle not the war. J. Hepatol.49(5), 871–873 (2008).
   PubMedGoogle Scholar
• Roberts LR. Sorafenib in liver cancer: just the beginning? N. Engl. J. Med.359(4), 420–422 (2008).
   PubMed Web of Science ®Google Scholar
• Pinter M, Sieghart W, Graziadei I et al. Sorafenib in unresectable hepatocellular carcinoma from mild to advanced stage liver cirrhosis. Oncologist14, 70–76 (2009).
   PubMed Web of Science ®Google Scholar
• Wu S, Chen JJ, Kudelka A, Lu J, Zhu X. Incidence and risk of hypertension with sorafenib in patients with cancer: a systematic review and meta-analysis. Lancet Oncol.9(2), 117–123 (2008).
   PubMed Web of Science ®Google Scholar
• Philip PA, Mahoney MR, Allmer C et al. Phase II study of erlotinib (OSI-774) in patients with advanced hepatocellular cancer. J. Clin. Oncol.23(27), 6657–6663 (2005).
   PubMed Web of Science ®Google Scholar
• Thomas MB, Morris JS, Chadha R et al. Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma. J. Clin. Oncol.27(6), 843–850 (2009).
   PubMed Web of Science ®Google Scholar
• Siegel AB, Cohen EI, Ocean A et al. Phase II trial evaluating the clinical and biologic effect of bevacizumab in unresectable hepatocellular carcinoma. J. Clin. Oncol.26(18), 2992–2998 (2008).
   PubMed Web of Science ®Google Scholar
• Zhu AX, Blaszkowsky LS, Ryan DP et al. Phase II study of gemcitabine and oxaliplatin in combination with bevacizumab in patients with advanced hepatocellular carcinoma. J. Clin. Oncol.24(12), 1898–1903 (2006).
   PubMed Web of Science ®Google Scholar
• Faivre SJ, Raymond E, Douillard J et al. Assessment of safety and drug-induced tumor necrosis with sunitinib in patients (pts) with unresectable hepatocellular carcinoma (HCC). Presented at: 43rd Annual Meeting of the American Society of Clinical Oncology. IL, USA, 2–5 June 2007 (Abstract 3546).
   Google Scholar
• Zhu AX, Sahani DV, di Tomaso E et al. Sunitinib monotherapy in patients with advanced hepatocellular carcinoma (HCC): insights from a multidisciplinary Phase II study. Presented at: 44th Annual Meeting of the American Society of Clinical Oncology. Chicago, IL, USA, 30 May–3 June 2008 (Abstract 4521).
   Google Scholar
• Llovet JM, Di Bisceglie AM, Bruix J et al. Design and end-points of clinical trials in hepatocellular carcinoma. J. Natl Cancer Inst.100(10), 698–711 (2008).
   PubMed Web of Science ®Google Scholar
• Finn RS, Kang Y, Park J, Harris R, Donica M, Walters I. Phase II, open label study of brivanib alaninate in patients (pts) with hepatocellular carcinoma (HCC) who failed prior antiangiogenic therapy. Presented at: 2009 Gastrointestinal Cancer Symposium. CA, USA, 15–17 January 2009 (Abstract 200).
   Google Scholar