A randomised phase II study of pegylated arginine deiminase (ADI-PEG 20) in Asian advanced hepatocellular carcinoma patients

British Journal of Cancer

Volumn 103, Issue 7, 2010, Pages 954-960

  Yang, T S ^a   Lu, S N ^b   Chao, Y ^c   Sheen, I S ^a   Lin, C C ^a   Wang, T E ^d   Chen, S C ^e   Wang, J H ^b   Liao, L Y ^f   Thomson, J A ^g   Wang Peng, J ^h   Chen, P J ⁱ   Chen, L T ^e,h,j  

^a CHANG GUNG UNIVERSITY   (Taiwan)

^b CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^c TAIPEI VETERANS GENERAL HOSPITAL   (Taiwan)

^d MACKAY MEMORIAL HOSPITAL   (Taiwan)

^e KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^f TAIPEI CITY HOSPITAL   (Taiwan)

^g Polaris Pharmaceuticals Inc   (United States)

^h NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

ⁱ NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^j NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

more..

Author keywords

arginine; arginine deiminase; argininosuccinate synthetase; hepatocellular carcinoma; polyethylene glycol

Indexed keywords

ADI PEG 20; ALPHA FETOPROTEIN; ANTINEOPLASTIC AGENT; PEGYLATED ARGININE DEIMINASE; UNCLASSIFIED DRUG; ARGININE; HYDROLASE; MACROGOL DERIVATIVE; PEGARGIMINASE;

ADULT; AGED; ALLERGY; ANEMIA; ARTICLE; CANCER CONTROL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG ACTIVITY; DRUG EFFICACY; DRUG FEVER; DRUG HYPERSENSITIVITY; FATIGUE; FEMALE; HEPATITIS C; HUMAN; HYPERAMMONEMIA; HYPERURICEMIA; IMMUNOGENICITY; INJECTION SITE REACTION; LIVER CELL CARCINOMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; TREATMENT RESPONSE; ASIAN CONTINENTAL ANCESTRY GROUP; BLOOD; CARCINOMA, HEPATOCELLULAR; DISEASE FREE SURVIVAL; LIVER NEOPLASMS; MIDDLE AGED; MORTALITY; RETREATMENT; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ARGININE; ASIAN CONTINENTAL ANCESTRY GROUP; CARCINOMA, HEPATOCELLULAR; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; HYDROLASES; LIVER NEOPLASMS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RETREATMENT;

EID: 77957245576     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605856     Document Type: Article

References (40)

1. Abou-Alfa GK, Venook AP (2008) The impact of new data in the treatment of advanced hepatocellular carcinoma. Curr Oncol Rep 10: 199-205
2. Bowles TW, Kim R, Galante J, Parsons CM, Virudachalam S, Kung HJ, Bold RJ (2008) Pancreatic cancer cell lines deficient in argininosuccinate synthetase are sensitive to arginine deprivation by arginine deiminase. Int J Cancer 123: 1950-1955
3. Bronte V, Zanovello P (2005) Regulation of immune responses by L-arginine metabolism. Nat Rev Immunol 5: 641-654 (Pubitemid 41113195)
4. Chen CH, Su WW, Yang SS, Chang TT, Cheng KS, Lin HH, Wu SS, Lee CM, Changchien CS, Chen CJ, Sheu JC, Chen DS, Lu SN (2006) Long-term trends and geographic variations in the survival of patients with hepatocellular carcinoma: analysis of 11 312 patients in Taiwan. J Gastroenterol Hepatol 21: 1561-1566 (Pubitemid 44266515)
5. Chen LT, Shiah HS, Chao Y, Chang JY, Cheng LT, Whang-Peng J (2009) Alpha-fetoprotein response in advanced hepatocellular carcinoma receiving cytostatic agent. J Clin Oncol 27: e271
6. Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z (2009) Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomized, double-blind, placebo-controlled trial. Lancet Oncol 10: 25-34
7. Curley SA, Bomalaski JS, Ensor CM, Holtsberg FW, Clark MA (2003) Regression of hepatocellular carcinoma in a patient treated with arginine deiminase. Hepatogastroenterology 50: 1208-1211
8. Delage B, Fennell DA, Nicholson L, McNeish I, Lemoine NR, Crook T, Szlosarek PW (2010) Arginine deprivation and arginino-succinate synthetase expression in the treatment of cancer. Int J Cancer 126: 2762-2772
9. Dillon BJ, Prieto VG, Curley SA, Enso CM, Holtsberg FW, Bomalaski JS, Clark MA (2004) Incidence and distribution of argininosuccinate synthetase deficiency in human cancers: a method for identifying cancers sensitive to arginine deprivation. Cancer 100: 826-833
10. Di Maio M, De Maio E, Perrone F, Pignata S, Daniele B (2002) Hepatocellular carcinoma: systemic treatments. J Clin Gastroenterol 35(5 Suppl 2): S109-S114 (Pubitemid 35278648)
11. El-Serag HB, Rudolph KL (2007) Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology 132: 2557-2576 (Pubitemid 46890874)
12. Ensor CM, Holtsberg FW, Bomalaski JS, Clark MA (2002) Pegylated arginine deiminase (ADI-SS PEG20,000mw) inhibits human melanomas and hepatocellular carcinomas in vitro and in vivo. Cancer Res 62: 5443-5450
13. Glazer ES, Piccirillo M, Albino V, Di Giacomo R, Palaia R, Mastro AA, Beneduce G, Castello G, De Rosa V, Petrillo A, Ascierto PA, Curley SA, Izzo F (2010) Phase II study of pegylated arginine deiminase for nonresectable and metastatic hepatocellular carcinoma. J Clin Oncol 28: 2220-2226
14. Gong H, Pöttgen C, Stüben G, Havers W, Stuschke M, Schweigerer L (2003) Arginine deiminase and other antiangiogenic agents inhibit unfavorable neuroblastoma growth: potentiation by irradiation. Int J Cancer 106: 723-728 (Pubitemid 36993396)
15. Holtsberg FW, Ensor CM, Steiner MR, Bomalaski JS, Clark MA (2002) Poly(ethylene glycol) (PEG) conjugated arginine deiminase: effects of PEG formulations on its pharmacological properties. J Control Release 80: 259-271
16. Izzo F, Marra P, Beneduce G, Castello G, Vallone P, De Rosa V, Cremona F, Ensor CM, Holtsberg FW, Bomalaski JS, Clark MA, Ng C, Curley SA (2004) Pegylated arginine deiminase treatment of patients with unresectable hepatocellular carcinoma: results from phase I/II studies. J Clin Oncol 22: 1815-1822 (Pubitemid 41095171)
17. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observation. J Am Stat Assoc 53: 457-481
18. Kenny GE, Pollock ME (1963) Mammalian cell cultures contaminated with pleuropneumonia-like organisms. I. Effect of pleuropneumonialike organisms on growth of established cell strains. J Infect Dis 112: 7-16
19. Kim RH, Bowles TL, Kung HJ (2009) ADI, autophagy and apoptosis: metabolic stress as a therapeutic option for prostate cancer. Autophagy 5: 567-568
20. Kraemer PM (1964) Mycoplasma (PPLO) from covertly contaminated tissue cultures: differences in arginine degradation between strains. Proc Soc Exp Biol Med 117: 910-918
21. Kraemer PM, Defendi V, Hayflick L, Manson LA (1963) Mycoplasma (PPLO) strains with lytic activity for murine lymphoma cells in vitro. Proc Soc Exp Biol Med 112: 381-387
22. Liaw YF, Tai DI, Chen TJ, Chu CM, Huang MJ (1986) Alpha-fetoprotein changes in the course of chronic hepatitis: relation to bridging hepatic necrosis and hepatocellular carcinoma. Liver 6: 133-137
23. Llovet J, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J, SHARP Investigators Study Group (2008) Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359: 378-390
24. Llovet JM (2005) Updated treatment approach to hepatocellular carcinoma. J Gastroenterol 40: 225-235 (Pubitemid 40613379)
25. ONeill BH, Venook AP (2007) Hepatocellular carcinoma: the role of the North American GI Steering Committee Hepatobiliary Task Force and the advent of effective drug therapy. Oncologist 12: 1425-1432
26. Peranzoni E, Marigo I, Dolcetti L, Ugel S, Sonda N, Taschin E, Mantelli B, Bronte V, Zanovello P (2007) Role of arginine metabolism in immunity and immunopathology. Immunobiology 212: 795-812 (Pubitemid 350246262)
27. Rogers QR (1994) Species Variation in Arginine Requirements, In Proceedings from a Symposium Honoring Willard J Visek-from Ammonia to Cancer and Gene Expression pp 9-21. Agriculture Experiment Station, University of Illinois: Urbana, IL
28. Ryder SD (2003) Guidelines for the diagnosis and treatment of hepatocellular carcinoma (HCC) in adults. Gut 52(Suppl 3): iii1-iii8
29. Shen LJ, Beloussow K, Shen WC (2006) Modulation of arginine metabolic pathways as the potential anti-tumor mechanism of recombinant arginine deiminase. Cancer Lett 231: 30-35 (Pubitemid 41779450)
30. Simon RM (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10: 1-10 (Pubitemid 19099520)
31. Slaton JW, Perrotte P, Inoue K, Dinney CP, Fidler IJ (1999) Interferon \{alpha\} mediated down-regulation of angio. Clin Cancer Res 5: 2726-2734
32. Sugimura K, Ohno T, Fukuda S, Wada Y, Kimura T, Azuma I (1990) Tumor growth inhibitory activity of a lymphocyte blastogenesis inhibitory factor. Cancer Res 50: 345-349 (Pubitemid 20041239)
33. Sun CA, Wu DM, Lin CC, Lu SN, You SL, Wang LY, Wu MH, Chen CJ (2003) Incidence and cofactors of hepatitis C virus-related hepatocellular carcinoma: a prospective study of 12,008 men in Taiwan. Am J Epidemiol 157: 674-682 (Pubitemid 36423080)
34. Takaku H, Misawa S, Hayashi H, Miyazaki K (1993) Chemical modification by polyethylene glycol of the anti-tumor enzyme arginine deiminase from Mycoplasma arginini. Jpn J Cancer Res 84: 1195-1200 (Pubitemid 23351013)
35. Takaku H, Takase M, Abe S-I, Hayashi H, Miyazaki K (1992) In vivo antitumor activity of arginine deiminase purified from Mycoplasma arginini. Int J Cancer 51: 244-249
36. Tapiero H, Mathe G, Couvreur P, Tew KD (2002) I. Arginine. Biomed Pharmacother 56: 439-445 (Pubitemid 35454031)
37. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2002) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216 (Pubitemid 30099779)
38. Tytell AA, Neuman RE (1960) Growth response of stable and primary cell cultures to L-ornithine, L-citrulline, and L-arginine. Exp Cell Res 20: 84-91
39. Yu AS, Keeffe EB (2003) Management of hepatocellular carcinoma. Rev Gastroenterol Disord 3: 8-24
40. Zhu AX (2008) Development of sorafenib and other molecularly targeted agents in hepatocellular carcinoma. Cancer 112: 250-259