Randomised clinical trial: Comparison of two everolimus dosing schedules in patients with advanced hepatocellular carcinoma

Alimentary Pharmacology and Therapeutics

Volumn 37, Issue 1, 2013, Pages 62-73

  Shiah, H S ^a,b,c   Chen, C Y ^b   Dai, C Y ^d   Hsiao, C F ^a   Lin, Y J ^b   Su, W C ^b   Chang, J Y ^a   Whang Peng, J ^a,e   Lin, P W ^b   Huang, J D ^f   Chen, L T ^a,b,d,f  

^a NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

^b NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^c TAIPEI MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^d KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^e TAIPEI MEDICAL UNIVERSITY   (Taiwan)

^f NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

Author keywords

[No Author keywords available]

Indexed keywords

EVEROLIMUS; HEPATITIS B SURFACE ANTIGEN; LAMIVUDINE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CANCER CONTROL; CANCER FATIGUE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DISEASE ASSOCIATION; DOSAGE SCHEDULE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFECT; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; LIMIT OF QUANTITATION; LIVER CELL CARCINOMA; MALE; MAXIMUM PLASMA CONCENTRATION; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THROMBOCYTOPENIA;

ADULT; AGED; CARCINOMA, HEPATOCELLULAR; DNA, VIRAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VIRUS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER CIRRHOSIS; LIVER NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; SIROLIMUS; YOUNG ADULT;

EID: 84870609803     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12132     Document Type: Article

References (43)

1. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM,. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127: 2893-917.
2. El-Serag HB, Rudolph KL,. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology 2007; 132: 2557-76.
3. Forner A, Llovet JM, Bruix J,. Hepatocellular carcinoma. Lancet 2012; 379: 1245-55.
4. Lopez PM, Villanueva A, Llovet JM,. Systematic review: evidence-based management of hepatocellular carcinoma-an updated analysis of randomized controlled trials. Aliment Pharmacol Ther 2006; 23: 1535-47.
5. National Comprehensive Cancer Network, Inc. NCCN Clinical Practice Guidelines in Oncology: Hepatobiliary Cancers. Version 2.2012. 2012. Available at: http://www.nccn.org/professionals/physician-gls/pdf/hepatobiliary.pdf. Accessed April 16, 2012.
6. European Association for the Study of the Liver; European Organisation for Research and Treatment of Cancer. EASL-EORTC Clinical Practice Guidelines: management of hepatocellular carcinoma. Eur J Cancer 2012; 48: 599-641.
7. Kanwal F, Befeler A, Chari RS, et al,. Potentially curative treatment in patients with hepatocellular cancer-results from the liver cancer research network. Aliment Pharmacol Ther 2012; 36: 257-65.
8. Llovet JM, Ricci S, Mazzaferro V, et al,. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008; 359: 378-90.
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, double-blind, placebo-controlled trial. Lancet Oncol 2009; 10: 25-34.
10. Shaw RJ, Cantley LC,. Ras, PI(3)K and mTOR signalling controls tumour cell growth. Nature 2006; 441: 424-30.
11. Sahin F, Kannangai R, Adegbola O, Wang J, Su G, Torbenson M,. mTOR and P70 S6 kinase expression in primary liver neoplasms. Clin Cancer Res 2004; 10: 8421-5.
12. Sieghart W, Fuereder T, Schmid K, et al,. Mammalian target of rapamycin pathway activity in hepatocellular carcinomas of patients undergoing liver transplantation. Transplantation 2007; 83: 425-32.
13. Varma S, Khandelwal RL,. Effects of rapamycin on cell proliferation and phosphorylation of mTOR and p70(S6K) in HepG2 and HepG2 cells overexpressing constitutively active Akt/PKB. Biochim Biophys Acta 2007; 1770: 71-8.
14. Guba M, von Breitenbuch P, Steinbauer M, et al,. Rapamycin inhibits primary and metastatic tumor growth by antiangiogenesis: involvement of vascular endothelial growth factor. Nat Med 2002; 8: 128-35.
15. Semela D, Piguet AC, Kolev M, et al,. Vascular remodeling and antitumoral effects of mTOR inhibition in a rat model of hepatocellular carcinoma. J Hepatol 2007; 46: 840-8.
16. Huynh H, Chow KH, Soo KC, et al,. RAD001 (everolimus) inhibits tumour growth in xenograft models of human hepatocellular carcinoma. J Cell Mol Med 2009; 13: 1371-80.
17. Villanueva A, Chiang DY, Newell P, et al,. Pivotal role of mTOR signaling in hepatocellular carcinoma. Gastroenterology 2008; 135: 1972-83.
18. Zaghla H, Selby RR, Chan LS, et al,. A comparison of sirolimus vs. calcineurin inhibitor-based immunosuppressive therapies in liver transplantation. Aliment Pharmacol Ther 2006; 23: 513-20.
19. Liang W, Wang D, Ling X, et al,. Sirolimus-based immunosuppression in liver transplantation for hepatocellular carcinoma: a meta-analysis. Liver Transpl 2012; 18: 62-9.
20. Kovarik JM, Sabia HD, Figueiredo J, et al,. Influence of hepatic impairment on everolimus pharmacokinetics: implications for dose adjustment. Clin Pharmacol Ther 2001; 70: 425-30.
21. Therasse P, Arbuck SG, Eisenhauer EA, et al,. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205-16.
22. Liu SF, Hsieh MH, Hou NJ, et al,. Hepatitis B virus genotyping by enzyme-linked immunosorbent assay in Taiwan. Hepatol Int 2010; 4: 601-7.
23. O'Donnell A, Faivre S, Burris HA III, et al,. Phase I pharmacokinetic and pharmacodynamic study of the oral mammalian target of rapamycin inhibitor everolimus in patients with advanced solid tumors. J Clin Oncol 2008; 26: 1588-95.
24. Okamoto I, Doi T, Ohtsu A, et al,. Phase I clinical and pharmacokinetic study of RAD001 (everolimus) administered daily to Japanese patients with advanced solid tumors. Jpn J Clin Oncol 2010; 40: 17-23.
25. Tabernero J, Rojo F, Calvo E, et al,. Dose- and schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumors. J Clin Oncol 2008; 26: 1603-10.
26. Zhu AX, Abrams TA, Miksad R, et al,. Phase 1/2 study of everolimus in advanced hepatocellular carcinoma. Cancer 2011; 117: 5094-102.
27. Motzer RJ, Escudier B, Oudard S, et al,. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010; 116: 4256-65.
28. Yao JC, Shah MH, Ito T, et al,. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011; 364: 514-23.
29. Baselga J, Campone M, Piccart M, et al,. Everolimus in postmenopausal hormone receptor-positive advanced breast cancer. N Engl J Med 2012; 366: 520-9.
30. Poon RTP, Finn RS, Yau T, et al,. Everolimus in combination with sorafenib in patients with advanced hepatocellular carcinoma. Hong Kong: Presented at the 5th Annual Conference of the International Liver Cancer Association, 2-4 Sep 2011.
31. Piguet AC, Saar B, Hlushchuk R, et al,. Everolimus augments the effects of sorafenib in a syngeneic orthotopic model of hepatocellular carcinoma. Mol Cancer Ther 2011; 10: 1007-17.
32. Hoofnagle JH,. Reactivation of hepatitis B. Hepatology 2009; 49: S156-65.
33. Stypmann J, Engelen MA, Eckernkemper S, et al,. Calcineurin inhibitor-free immunosuppression using everolimus (Certican) after heart transplantation: 2 years' follow-up from the University Hospital Munster. Transplant Proc 2011; 43: 1847-52.
34. Guo H, Zhou T, Jiang D, et al,. Regulation of hepatitis B virus replication by the phosphatidylinositol 3-kinase-akt signal transduction pathway. J Virol 2007; 81: 10072-80.
35. Teng CF, Wu HC, Tsai HW, Shiah HS, Huang W, Su IJ,. Novel feedback inhibition of surface antigen synthesis by mammalian target of rapamycin (mTOR) signal and its implication for hepatitis B virus tumorigenesis and therapy. Hepatology 2011; 54: 1199-207.
36. Davies SE, Portmann BC, O'Grady JG, et al,. Hepatic histological findings after transplantation for chronic hepatitis B virus infection, including a unique pattern of fibrosing cholestatic hepatitis. Hepatology 1991; 13: 150-7.
37. Benner KG, Lee RG, Keeffe EB, Lopez RR, Sasaki AW, Pinson CW,. Fibrosing cytolytic liver failure secondary to recurrent hepatitis B after liver transplantation. Gastroenterology 1992; 103: 1307-12.
38. Lau JY, Bain VG, Davies SE, et al,. High-level expression of hepatitis B viral antigens in fibrosing cholestatic hepatitis. Gastroenterology 1992; 102: 956-62.
39. Meuleman P, Libbrecht L, Wieland S, et al,. Immune suppression uncovers endogenous cytopathic effects of the hepatitis B virus. J Virol 2006; 80: 2797-807.
40. Jung S, Lee HC, Han JM, et al,. Four cases of hepatitis B virus-related fibrosing cholestatic hepatitis treated with lamivudine. J Gastroenterol Hepatol 2002; 17: 345-50.
41. Schöniger-Hekele M, Müller C,. Pilot study: rapamycin in advanced hepatocellular carcinoma. Aliment Pharmacol Ther 2010; 32: 763-8.
42. Rizell M, Andersson M, Cahlin C, Hafstrom L, Olausson M, Lindner P,. Effects of the mTOR inhibitor sirolimus in patients with hepatocellular and cholangiocellular cancer. Int J Clin Oncol 2008; 13: 66-70.
43. Vauthey JN, Lauwers GY, Esnaola NF, et al,. Simplified staging for hepatocellular carcinoma. J Clin Oncol 2002; 20: 1527-36.