Azathioprine, a genotoxic agent to be considered non-genotoxic in man

Mutation Research/Reviews in Genetic Toxicology - Tập 221 - Trang 133-152 - 1989
C.E. Voogd1
1National Institute of Public Health and Environmental Protection, Bilthoven, The Netherlands

Tài liệu tham khảo

Abraham, 1985, Influence of hepatic oxidative metabolism on the immunosuppressive activities of 6-thiopurine, J. Pharmacol. Exp. Ther., 234, 670 Adamson, 1983, Chemical carcinogenesis studies in non human primates, Basic Life Sci., 24, 129 Apelt, 1981, Azathioprine, a clastogen in human somatic cells? Analysis of chromosome damage and SCE in lymphocytes after exposure in vivo and in vitro, Mutation Res., 88, 61, 10.1016/0165-1218(81)90090-2 Ashby, 1985, Tabulation and assessment of 113 human surveillance cytogenetic studies conducted between 1965 and 1984,, Mutation Res., 154, 111, 10.1016/0165-1110(85)90023-5 Bach, 1970, Etudes sur le métabolisme de l'azathioprine, C.R. Acad. Sci. Paris, 271, 453 Blumberg, 1986, Association between transfusion of whole blood and recurrence of cancer, Br. Med. J., 293, 530, 10.1136/bmj.293.6546.530 Bruce, 1979, The mutagenic activity of 61 agents as determined by the micronucleus, Salmonella, and sperm abnormality assays, Can. J. Genet. Cytol., 21, 319, 10.1139/g79-036 Cantrell, 1983, Transient expression of interleukin 2 receptors: consequences for T cell growth, J. Exp. Med., 158, 1895, 10.1084/jem.158.6.1895 Casey, 1968, The development of lymphomas in mice with autoimmune disorders treated with azathioprine, Blood, 31, 396, 10.1182/blood.V31.3.396.396 Casey, 1968, Azathioprine (Imuran) administration and the development of malignant lymphomas in NZB mice, Clin. Exp. Immunol., 3, 305 Cavallo, 1983, Murine lupus nephritis: effect of azathioprine on glomerular permeability and localization of immunoreactions, Clin. Exp. Immunol., 53, 547 Chalmers, 1974, Studies on the mechanism of formation of 5-mercapto-1-methyl-4-nitroimidazole, a metabolite of the immunosuppressive drug azathioprine, Biochem. Pharmacol., 23, 1891, 10.1016/0006-2952(74)90198-1 Chalmers, 1967, Conversion of azathioprine into mercaptopurine and mercaptoimidazole derivative in vitro and during immunosuppressive therapy, Aust. J. Exp. Biol. Med. Sci., 45, 681, 10.1038/icb.1967.68 Chapman, 1983, Characteristics of the metabolism-induced binding of misonidazole to hypoxic mammalian cells, Cancer Res., 43, 1523 Clark, 1975, The mutagenicity of azathioprine in mice, Drosophila melanogaster and Neurospora crassa, Mutation Res., 28, 87, 10.1016/0027-5107(75)90318-8 Clarke, 1980, Anaerobic reduction of nitroimidazoles by reduced flavin mononucleotide and by xanthine oxidase, Biochem. Pharmacol., 29, 2684, 10.1016/0006-2952(80)90087-8 Clarke, 1982, Nitroimidazoles as anaerobic electron acceptors for xanthine oxidase, Biochem. Pharmacol., 31, 3237, 10.1016/0006-2952(82)90556-1 Cockburn, 1987, Assessment of the risks of malignancy and lymphomas developing in patients using Sandimmune, 19, 1804 Cohen, 1983, Azathioprine induction of lymphomas and squamous cell carcinomas in rats, Cancer Res., 43, 2768 Dalke, 1984, Hypoxanthine-guanine phosphoribosyltransferase independent toxicity of azathioprine in human lymphoblasts, Biochem. Pharmacol., 33, 2692, 10.1016/0006-2952(84)90648-8 Declerk, 1986, In vitro reductive activation of nitroimidazoles, Biochem. Pharmacol., 35, 59, 10.1016/0006-2952(86)90555-1 Doell, 1964, Immune reactivity prior to development of thymic lymphoma in C57-Bl mice, Int. J. Cancer, 2, 103, 10.1002/ijc.2910020205 Drath, 1983, Pulmonary macrophage and polymorphonuclear leukocyte function in response to immunosuppressive therapy, Transplant. Proc., 15, 2367 Eastgate, 1988, Correlation of plasma interleukin 1 levels with disease activity in rheumatoid arthritis, Lancet, ii, 706, 10.1016/S0140-6736(88)90185-7 Eberle, 1968, Chromosomes in patients treated with Imuran, Humangenetik, 6, 69, 10.1007/BF00287156 Edwards, 1986, Reduction of nitroimidazole in vitro and DNA damage, Biochem. Pharmacol., 35, 53, 10.1016/0006-2952(86)90554-X Ehlhardt, 1988, Mammalian cell toxicity and bacterial mutagenicity of nitrosoimidazoles, Biochem. Pharmacol., 37, 2603, 10.1016/0006-2952(88)90252-3 Elion, 1975, Azathioprine, Vol. XXXVIII/2, 403 Epstein, 1972, Detection of chemical mutagens by the dominant lethal assay in the mouse, Toxicol. Appl. Pharmacol., 23, 288, 10.1016/0041-008X(72)90192-5 Fein, 1976, Effect of azathioprine in the implanting trophoblast in rats, Isr. J. Med. Sci., 12, 86 Fein, 1983, Effect of Imuran® on placental and fetal development in rats, Isr. J. Med. Sci., 19, 73 Flint, 1984, An in vitro assay for teratogens with cultures of rat embryo midbrain and limbbud cells, Toxicol. Appl. Pharmacol., 76, 383, 10.1016/0041-008X(84)90020-6 Flint, 1984, Differentiation of rat embryo cells in culture: response following acute maternal exposure to teratogens and non-teratogens, J. Appl. Toxicol., 4, 109, 10.1002/jat.2550040211 Frankel, 1970, Chronic toxicity of azathioprine and the effect of this immunosuppressant on liver tumor induction by the carcinogen N-hydroxy-N-2-fluorenylacetamide, Toxicol. Appl. Pharmacol., 17, 462, 10.1016/0041-008X(70)90203-6 Friedrich, 1970, Chromosomenabnormitäten und Behandlung mit Imuran® (Azathioprin) nach Nierentransplantationen, Humangenetik, 8, 289, 10.1007/BF00280326 Ganner, 1973, Chromosomes in patients treated with azathioprine, Humangenetik, 18, 231, 10.1007/BF00290602 Gelfand, 1972, Therapeutic studies in NZB/W mice. II. Relative efficiency of azathioprine, cyclophosphamide and methylprednisolone, Arthr. Rheum., 15, 247, 10.1002/art.1780150305 Goldman, 1986, Comparing the reduction of nitroimidazoles in bacteria and mammalian tissues and relating it to biological activity, Biochem. Pharmacol., 35, 43, 10.1016/0006-2952(86)90553-8 Gordon, 1982, 6-Substituted purines: a novel class of inhibitors of endogenous protein degradation in isolated rat hepatocytes, Arch. Biochem. Biophys., 217, 282, 10.1016/0003-9861(82)90504-5 Goustin, 1986, Growth factors and cancer, Cancer Res., 46, 1015 Hahn, 1975, Influence of cyclophosphamide and other immunosuppressive drugs on immune disorders and neoplasia in NZB/NZW mice, Arthr. Rheum., 18, 145, 10.1002/art.1780180212 Hampel, 1971, Chromosomenmutationen durch Azathioprin bei menschlichen Leukozyten in vitro, Z. Gastroenterol., 9, 47 Harvey, 1979, Azathioprine-in-duced lymphocytic neoplasms of NZB-mice lack ecotropic murine leukemia virus, Int. J. Cancer, 23, 217, 10.1002/ijc.2910230213 Hazleman, 1982, The comparative incidence of malignant disease in rheumatoid arthritics exposed to different treatment regimens, Ann. Rheum. Dis., 41, 12, 10.1136/ard.41.Suppl_1.12 Heddle, 1977, On the use of multiple assays for mutagenicity especially the micronucleus, Salmonella, and sperm abnormality assays, Dev. Toxicol. Environ. Sci., 2, 265 Herbold, 1978, Mutagenitätuntersuchungen mit dem Lebermikrosomentest, Biol. Zbl., 97, 137 Herbold, 1976, Induction of point mutations by different chemical mechanisms in the liver microsomal assay, Mutation Res., 40, 73, 10.1016/0165-1218(76)90001-X Herbold, 1976, Kritische Betrachtung zum Lebermikrosomentest, einem System zum Nachweis von Punktmutationen, Arzneim. Forsch., 26, 1705 Herbold, 1977, Pointmutation research: relevance for humans, J. Toxicol. Environ. Health, 2, 1183, 10.1080/15287397709529516 Hobara, 1981, Impaired-metabolism of azathioprine in carbon tetrachloride-injured rats, Hepato-Gastroenterol, 28, 192 Holden, 1973, Mutagenicity studies with 6-mercaptopurine: I. Cytogenetic activity in vivo, Mutation Res., 20, 257, 10.1016/0027-5107(73)90195-4 IARC, 1981, Azathioprine, IARC Monographs, Vol. 26, 47 IARC, 1982, Azathioprine, IARC Monographs, 55 IARC, 1987, Monographs Iigo, 1988, In vivo antitumor activity of multiple injections of recombinant interleukin 2, alone and in combination with three different types of recombinant interferon in various syngeneic murine tumors, Cancer Res., 48, 260 Jacobs, 1981, 13, 729 Jelinek, 1985, Chick embryotoxicity screening test−130 substances tested, Indian J. Exp. Biol., 23, 588 Kinlen, 1982, Immunosuppressive therapy and cancer, Cancer Surv., 1, 566 Klein, 1987, Genetic control of immune response: new concepts and old misconceptions, J. Pediatr., 11, 997 Kotulová, 1983, Phagocytic capacity of human leukocytes preincubated with Imuran and prednison, J. Hyg. Epidemiol. Microbiol. Immunol., 27, 253 Krogh Jensen, 1967, Chromosome studies in patients treated with azathioprine and amethopterin, Acta Med. Scand., 182, 445, 10.1111/j.0954-6820.1967.tb10869.x Krogh Jensen, 1970, Effect of azathioprine on the chromosome complement of human bone marrow cells, Int. J. Cancer, 5, 147, 10.1002/ijc.2910050119 Krogh Jensen, 1976, Assessment of the effect of azathioprine in human bone marrow cells in vivo, combining chromosome studies and the micronucleus test, Danish Med. Bull., 23, 153 Krogh Jensen, 1966, Chromosome aberrations in human cells following treatment with Imuran, Acta Med. Scand., 179, 249, 10.1111/j.0954-6820.1966.tb05454.x Kučerová, 1976, Cytogenetic analysis of human chromosomes and its value for the estimation of genetic risk, Mutation Res., 41, 123, 10.1016/0027-5107(76)90082-8 Kučerová, 1982, Chromosomal aberrations and sister-chromatid exchanges (SCEs) in patients undergoing long-term Imuran therapy, Mutation Res., 94, 501, 10.1016/0027-5107(82)90310-4 Lawson, 1984, Adverse effect of azathioprine, Adv. Drug. React. Ac. Pois, Rev., 3, 161 Lennard, 1983, Assay of 6-thioguanine nucleotide, a major metabolite of azathioprine, 6-mercaptopurine and 6-thioguanine, in human red-blood cells, J. Pharm. Pharmacol., 35, 15, 10.1111/j.2042-7158.1983.tb04255.x Lennard, 1986, The effect of folate supplements on 6-mercaptopurine remission maintenance therapy in childhood leukaemia, Br. J. Cancer, 53, 115, 10.1038/bjc.1986.16 Lennard, 1986, Oral 6-mercaptopurine in childhood leukemia: parent drug pharmacokinetics and active metabolite concentrations, Clin. Pharmacol. Ther., 40, 287, 10.1038/clpt.1986.178 Levy, 1972, The effect of azathioprine on gammaglobulin synthesis in man, J. Clin. Invest., 51, 2233, 10.1172/JCI107031 Lipsmeyer, 1972, Development of malignant cerebral lymphoma in a patient with systemic lupus erythematosus treated with immunosuppression, Arthr. Rheum., 15, 182, 10.1002/art.1780150207 Manyonda, 1986, Renal cell carcinoma: blood transfusion and survival, Br. Med. J., 293, 537, 10.1136/bmj.293.6546.537-a Matter, 1982, Genotoxicity evaluation of cyclosporin A1, a new immunosuppression agent, Mutation Res., 105, 257, 10.1016/0165-7992(82)90039-2 MacLeod, 1988, Cancer after transplantation. The risks are small, Br. Med. J., 297, 4, 10.1136/bmj.297.6640.4 McAdam, 1974, Adenocarcinoma of the lung during azathioprine therapy, Arthr. Rheum., 17, 92, 10.1002/art.1780170114 McEwan, 1972, Oncogenicity of immunosuppressive drugs, Lancet, i, 326, 10.1016/S0140-6736(72)90341-8 McGeown, 1988, Ten-year results of renal transplantation with azathioprine and prednisolone as only immunosuppression, Lancet, i, 983, 10.1016/S0140-6736(88)91792-8 Mellors, 1969, Murine leukemialike virus and the immunopathological disorders of New Zealand black mice, J. Infect. Dis., 120, 480, 10.1093/infdis/120.4.480 Merkatz, 1971, Resumption of female reproductive function following renal transplation, J. Am. Med. Ass., 216, 1749, 10.1001/jama.1971.03180370025005 Mitrou, 1979, The oncogenic effect of immunosuppressive (cytotoxic) agents in (NZB × NZW) mice. I. Long-term treatment with azathioprine and ifosfamide, Arzneim. Forsch., 29, 483 Mitrou, 1979, The oncogenic effect of immunosuppressive (cytotoxic) agents in (NZB × NZW) mice. II. Emergence of tumors in young animals treated with azathioprine and ifosfamide, including a histologic assessment of the neoplasms, Arzneim. Forsch., 29, 662 Miwa, 1982, Drug residue formation from ronidazole, a 5-nitroimidazole. III. Studies on the mechanism of protein alkylation in vitro, Chem.-Biol. Interact., 41, 297, 10.1016/0009-2797(82)90107-7 Nepomnaschy, 1984, Effect of the rat liver S9 fraction on the mutagenicity of azathioprine in the Salmonella/mammalian microsome assay, Experientia, 40, 370, 10.1007/BF01952557 Neubert, 1977, Interference of 6-mercaptopurine riboside, 6-methylmercaptopurine riboside and azathioprine with the morphogenetic differentiation of mouse extremities in vivo and in organ culture, Naunyn-Schmiedeberg's Arch. Pharmacol., 298, 93, 10.1007/BF00508616 Noss, 1988, Preparation, toxicity and mutagenicity of 1-methyl-2-nitroimidazole, Biochem. Pharmacol., 37, 2585, 10.1016/0006-2952(88)90250-X Obe, 1970, Die Wirkung von 6-Mercaptopurin und Azathioprin auf menschliche Chromosomen in vitro, Arzneim. Forsch., 21, 504 O'Garra, 1988, B-Cell factors are pleiotropic, Immunol. Today, 9, 45, 10.1016/0167-5699(88)91259-5 Penn, 1987, Cancers following cyclosporine therapy, 19, 2211 Penn, 1971, De novo malignant tumors in organ transplant recipients, 3, 773 Penn, 1971, Parenthood in renal homograft recipients, J. Am. Med. Ass., 216, 1755, 10.1001/jama.1971.03180370031006 Perez-Reyes, 1980, The reductive metabolism of metronidazole and ronidazole by aerobic liver microsomes, Mol. Pharmacol., 17, 239 Racine, 1984, Monitoring chemically induced DNA damage in the germ cells of male mice, Arch. Toxicol., 174, 10.1007/978-3-642-69132-4_25 Raleigh, 1983, Reductive fragmentation of 2-nitroimidazoles in the presence of nitroreductases - glyoxal formation from misonidazole, Biochem. Pharmacol., 32, 1444, 10.1016/0006-2952(83)90460-4 Reeve, 1985, Effect of immunosuppressive agents and sunscreens on UV carcinogenesis in the hairless mouse, Aust. J. Exp. Biol. Med. Sci., 63, 655, 10.1038/icb.1985.69 Rosenberg, 1988, Immunotherapy of cancer using interleukin 2: current status and future prospects, Immunol. Today, 9, 58, 10.1016/0167-5699(88)91261-3 Rowley, 1969, Antibody production in immunosuppressed recipients of renal allografts, Lancet, ii, 708, 10.1016/S0140-6736(69)90425-5 Rustia, 1979, Experimental induction of hepatomas, mammary tumors, and other tumors with metronidazole in non-inbred Sas: MRC (W1) BR rat, J. Natl. Cancer Inst., 63, 863, 10.1093/jnci/63.3.863 Saarikoski, 1973, Immunosuppression during pregnancy: transmission of azathioprine and its metabolites from the mother to the fetus, Am. J. Obstet. Gynecol., 115, 1100, 10.1016/0002-9378(73)90559-0 Scharf, 1977, Carcinoma of the bladder with azathioprine therapy, J. Am. Med. Ass., 237, 152, 10.1001/jama.1977.03270290052028 Schinzel, 1976, Lymphocyte chromosome studies in humans exposed to chemical mutagens, Mutation Res., 40, 139, 10.1016/0165-1218(76)90009-4 Schmid, 1984, Monitoring of organ formation in rat embryos after in vitro exposure to azathioprine, mercaptopurine, methotrexate or cyclosporin A, Toxicology, 31, 9, 10.1016/0300-483X(84)90151-3 Schmid, 1985, Xenobiotic influences on embryonic differentiation, growth and morphology in vitro, Xenobiotica, 15, 719, 10.3109/00498258509047433 Schmid, 1983, Validation of the whole-embryo culture method for in vitro teratogenicity testing, Dev. Sci. Pract. Toxicol., 11, 563 Schneck, 1971, De novo brain tumors in renal-transplant recipients, Lancet, i, 983, 10.1016/S0140-6736(71)91384-5 Schultz, 1987, Interleukin 1 and interferon-γ: cytokines that provide reciprocal regulation of macrophage and T cell function, Toxicol. Pathol., 15, 333, 10.1177/019262338701500311 Schwartz, 1972, Immunoregulation, oncogenic viruses, and malignant lymphomas, Lancet, i, 1266, 10.1016/S0140-6736(72)90985-3 Scott, 1988, Adverse reactions and interactions of cyclosporin, Med. Toxicol., 3, 107, 10.1007/BF03259936 Scott, 1977, A study of maternal lymphoid organs and the progeny following treatment with immunomodulating agents, Clin. Exp. Immunol., 30, 393 Sheil, 1979, Cancer and survival after cadaveric donor renal transplantation, 9, 1052 Sheil, 1981, Cancer following successful cadaveric donor renal transplantation, 13, 733 Sheil, 1987, Cancer incidence in renal transplant patients treated with azathioprine or cyclosporine, 19, 2214 Silver, 1986, Induction of DNA strand breaks by reduced nitroimidazoles, Biochem. Pharmacol., 35, 3923, 10.1016/0006-2952(86)90005-5 Sono, 1982, Genetic toxicology tests on mizoribine (bredinin), Pharmacometrics, 24, 703 Speck, 1976, Mutagenicity of azathioprine, Cancer Res., 36, 108 Sulh, 1986, Pharmacokinetic determinants of 6-mercaptopurine myelotoxicity and therapeutic failure in children with acute lymphoblastic leukemia, Clin. Pharmacol. Ther., 40, 604, 10.1038/clpt.1986.233 Tam, 1984, Evaluation of immunomodulatory chemicals: alteration of macrophage function in vitro, Toxicol. Appl. Pharmacol., 76, 183, 10.1016/0041-008X(84)90041-3 Terada, 1984, A microangiographic study of renal allograft rejection and the effects of immunosuppression in the rabbit, Transplantation, 37, 443, 10.1097/00007890-198405000-00004 Tilney, 1987, Humoral and cellular mechanisms in acute cellograft injury, J. Pediatr., 111, 1000, 10.1016/S0022-3476(87)80044-6 Tsuchimoto, 1979, In vivo cytogenetic screening methods for mutagens, with special reference to the micronucleus test, Arch. Toxicol., 42, 239, 10.1007/BF00334837 Tuchmann-Duplessis, 1968, Foetopathies thérapeutiques. Production expérimentale de malformations des membres, Union Méd. Canada, 97, 283 Turner, 1983, Antirheumatic drug effects on neutrophil response to chemotactic factors: a comparison of analytical techniques, 173, 200 Turner, 1983, Neutrophil migration in response to chemotactic factors: effects of generation conditions and chemotherapeutic agents, Inflammation, 7, 57, 10.1007/BF00918008 Unglaub-Leisten, 1975, Chromosomenuntersuchungen und peripheren Lymphozyten bei Patienten mit multipler Sklerose, Dtsch. Med. Wschr., 100, 2028, 10.1055/s-0028-1106496 Van Scoik, 1985, The pharmacology and metabolism of the thiopurine drugs 6-mercaptopurine and azathioprine, Drug Metab. Rev., 16, 157, 10.3109/03602538508991433 Van Went, 1979, Investigation into the mutagenic activity of azathioprine (Imuran®) in different test systems, Mutation Res., 68, 153, 10.1016/0165-1218(79)90143-5 Van Zyl, 1974, The clastogenic effect of azathioprine on human chromosomes in vitro, Humangenetik, 21, 153, 10.1007/BF00281034 Voogd, 1981, On the mutagenicity of nitroimidazoles, Mutation Res., 86, 243, 10.1016/0165-1110(81)90006-3 Voogd, 1979, The mutagenic action of nitroimidazoles. IV. A comparison of the mutagenic action of several nitroimidazoles and some imidazoles, Mutation Res., 66, 207, 10.1016/0165-1218(79)90082-X Wardman, 1979, The use of nitroaromatic compounds as hypoxic cell radio sensitizers, Curr. Topics Radiat. Res. Q., 11, 347 West, 1982, Drug residue formation from ronidazole, a 5-nitroimidazole. I. Characterization of in vitro protein alkylation, Chem.-Biol. Interact., 41, 265, 10.1016/0009-2797(82)90105-3 West, 1982, Drug residue formation from ronidazole, a 5-nitroimidazole. II. Involvement of microsomal NADPH-cytochrome P-450 reductase on protein alkylation in vitro, Chem.-Biol. Interact., 41, 281, 10.1016/0009-2797(82)90106-5 Wheland, 1972, Immunosuppressive activity in patients with active chronic hepatitis and primary biliary cirrhosis treated with azathioprine, Gut, 13, 907, 10.1136/gut.13.11.907 Williamson, 1981, Azathioprine teratogenicity: review of the literature and case report, Obstet. Gynecol., 58, 247 Winkelstein, 1979, The effect of azathioprine and 6-MP on immunity, J. Immunopharmacol., 1, 429, 10.3109/08923977909040545 Wislocki, 1984, Drug residue formation from ronidazole, a 5-nitroimidazole. V. Cysteine adducts formed upon reduction of ronidazole by dithionite or rat liver enzymes in the presence of cysteine, Chem.-Biol. Interact., 49, 13, 10.1016/0009-2797(84)90049-8 Wislocki, 1984, Drug residue formation from ronidazole, a 5-nitroimidazole. VI. Lack of mutagenic activity of reduced metabolites and derivatives of ronidazole, Chem.-Biol. Interact., 49, 27, 10.1016/0009-2797(84)90050-4 Workman, 1982, Structure/activity relationships for the enhancement by electron-affinic drugs of the anti-tumour effect of CCNU, Br. J. Cancer, 46, 249, 10.1038/bjc.1982.190 Wyrobek, 1975, Chemical induction of sperm abnormalities in mice, 72, 4425 Yeh, 1983, Pyrroline-5-carboxylate stimulates the conversion of purine antimetabolites to their nucleotide forms by a redox-dependent mechanism, J. Biol. Chem., 258, 9774, 10.1016/S0021-9258(17)44565-0 Yeung, 1983, Reduction of nitroheterocyclic compounds by mammalian tissues in vivo, Biochem. Pharmacol., 32, 2244