A phase II study of sunitinib in advanced hepatocellular carcinoma

Digestive and Liver Disease

Volumn 45, Issue 8, 2013, Pages 692-698

  Barone, Carlo ^a   Basso, Michele ^a   Biolato, Marco ^a   Pompili, Maurizio ^a   Rufini, Vittoria ^a   Miele, Luca ^a   Basso, Maria ^a   De Gaetano, Anna Maria ^a   Castaldi, Paola ^a   Iaculli, Alessandro ^a   Leccisotti, Lucia ^a   Riccardi, Laura ^a   Grieco, Antonio ^a  

^a CATHOLIC UNIVERSITY   (Italy)

Author keywords

Alpha fetoprotein; Aminopyrine; Methacetin; PET

Indexed keywords

ALCOHOL; SUNITINIB;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BRAIN DISEASE; CANCER CHEMOTHERAPY; CANCER PATIENT; CHEMOEMBOLIZATION; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; INJECTION; LIVER CELL CARCINOMA; LIVER CIRRHOSIS; LIVER FAILURE; LIVER FUNCTION; LIVER RESECTION; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; OVERALL SURVIVAL; PERCUTANEOUS ETHANOL INJECTION; PHASE 2 CLINICAL TRIAL; PORTAL VEIN THROMBOSIS; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RADIOFREQUENCY ABLATION; TREATMENT DURATION; TREATMENT RESPONSE; TUMOR GROWTH; UPPER GASTROINTESTINAL BLEEDING;

ALPHA-FETOPROTEIN; AMINOPYRINE; METHACETIN; PET;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, HEPATOCELLULAR; DISEASE PROGRESSION; FEMALE; HUMANS; INDOLES; LIVER NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PYRROLES; RISK ASSESSMENT; RISK FACTORS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84881552690     PISSN: 15908658     EISSN: 18783562     Source Type: Journal    
DOI: 10.1016/j.dld.2013.01.002     Document Type: Article

References (30)

1. Ferlay J., Shin H.R., Bray F., et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. International Journal of Cancer 2010, 127:2893-2917.
2. El-Serag H.B., Rudolph K.L. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology 2007, 132:2557-2576.
3. Llovet J.M., Di Bisceglie A.M., Bruix J., et al. Design and endpoints of clinical trials in hepatocellular carcinoma. Journal of the National Cancer Institute 2008, 100:698-711.
4. Llovet J.M., Brú C., Bruix J. Prognosis of hepatocellular carcinoma: the BCLC staging classification. Seminars in Liver Disease 1999, 19:329-338.
5. Wilhelm S.M., Adnane L., Newell P., et al. Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling. Molecular Cancer Therapeutics 2008, 7:3129-3140.
6. Llovet J.M., Ricci S., Mazzaferro V., et al. Sorafenib in advanced hepatocellular carcinoma. New England Journal of Medicine 2008, 359:378-390.
7. Cheng A.L., Kang Y.K., 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 Oncology 2009, 10:25-34.
8. Demetri G.D., van Oosterom A.T., Garrett C.R., et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet 2006, 368:1329-1338.
9. Motzer R.J., Hutson T.E., Tomczak P., et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. New England Journal of Medicine 2007, 356:115-124.
10. Raymond E., Dahan L., Raoul J.L., et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. New England Journal of Medicine 2011, 364:501-513.
11. Zhu A.X., Raymond E. Early development of sunitinib in hepatocellular carcinoma. Expert Review of Anticancer Therapy 2009, 9:143-150.
12. Therasse P., Arbuck S.G., Eisenhauer E.A., 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. Journal of the National Cancer Institute 2000, 92:205-216.
13. Common Terminology Criteria for Adverse Event (CTCAE) version 3.0, edited 2003 December 12 by National Cancer Institute (NCI). http://ctep.cancer.gov/reporting/ctc.html.
14. 13C-aminopyrine breath test to evaluate severity of disease in patients with chronic hepatitis C virus infection. Alimentary Pharmacology and Therapeutics 2002, 16:717-725.
15. Boellaard R., O'Doherty M.J., Weber W.A., et al. FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0. European Journal of Nuclear Medicine and Molecular Imaging 2010, 37:181-200.
16. 18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations, European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. European Journal of Cancer 1999, 35:1773-1782.
17. Simon R. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989, 10:1-10.
18. Zhu A.X., Sahani D.V., Duda D.G., et al. Efficacy, safety, and potential biomarkers of sunitinib monotherapy in advanced hepatocellular carcinoma: a phase II study. Journal of Clinical Oncology 2009, 27:3027-3035.
19. Koeberle D., Montemurro M., Samaras P., et al. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist 2010, 15:285-292.
20. Faivre S., Raymond E., Boucher E., et al. Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study. Lancet Oncology 2009, 10:794-800.
21. Armuzzi A., Candelli M., Zocco M.A., et al. Review article: breath testing for human liver function assessment. Alimentary Pharmacology and Therapeutics 2002, 16:1977-1996.
22. Fernández M., Semela D., Bruix J., et al. Angiogenesis in liver disease. Journal of Hepatology 2009, 50:604-620.
23. Miller A.A., Murry D.J., Owzar K., et al. Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301. Journal of Clinical Oncology 2009, 27:1800-1805.
24. Basso M., Basso M., Iaculli A., et al. Complete metabolic response with recanalization of portal vein tumor thrombosis after sunitinib in a patient with advanced hepatocellular carcinoma. Case Reports in Oncology 2010, 3:391-396.
25. Cheng A., Kang Y., Lin D., et al. Phase III trial of sunitinib versus sorafenib in advanced hepatocellular carcinoma. Journal of Clinical Oncology 2011, 29:A4000.
26. 13C-aminopyrine breath test accurately predict long-term outcome of chronic hepatitis C. Journal of Hepatology 2012, 56:782-787.
27. 18F-fluorodeoxyglucose positron emission tomography for monitoring response to sorafenib treatment in patients with hepatocellular carcinoma. Oncologist 2008, 13:734-735.
28. Hain S.F., Fogelman I. Recent advances in imaging hepatocellular carcinoma: diagnosis, staging and response assessment: functional imaging. Cancer Journal 2004, 10:121-127.
29. Shankar L.K., den Abbeele A.V., Yap J., Benjamin R., et al. Considerations for the use of imaging tools for phase II treatment trials in oncology. Clinical Cancer Research 2009, 15:1891-1897.
30. Holdsworth C.H., Badawi R.D., Manola J.B., et al. CT and PET: early prognostic indicators of response to imatinib mesylate in patients with gastrointestinal stromal tumor. American Journal of Roentgenology 2007, 189:324-330.