Are lifespan rodent carcinogenicity studies defensible for pharmaceutical agents?

Experimental and Toxicologic Pathology

Volumn 48, Issue 2-3, 1996, Pages 155-166

  Monro, A ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Bioassay, carcinogenicity; Carcinogenicity, bioassay; Carcinogenicity, lifespan studies; Lifespan rodent carcinogenicity studies; Pharmaceutical agents, carcinogenicity

Indexed keywords

ANTINEOPLASTIC AGENT; ARSENIC; AZATHIOPRINE; BUSULFAN; CHLORAMBUCIL; CHLORMETHINE; CHLORNAPHAZINE; COAL TAR; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; DIETHYLSTILBESTROL; ESTROGEN; HORMONE; MELPHALAN; METHOXSALEN; ORAL CONTRACEPTIVE AGENT; PHENACETIN; PREDNISONE; PROCARBAZINE; SEMUSTINE; THIOTEPA; TOPICAL AGENT; TREOSULFAN; VINCRISTINE;

ANIMAL MODEL; BIOASSAY; CANCER RISK; CHEMICAL CARCINOGENESIS; CONFERENCE PAPER; CONTROLLED STUDY; GENOTOXICITY; NONHUMAN; RODENT; TOXICOLOGY;

ANIMALIA; RODENTIA;

EID: 0030005665     PISSN: 09402993     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0940-2993(96)80036-4     Document Type: Conference Paper

References (70)

1. ALISON RH, CAPEN CC, PRENTICE DE: Neoplastic lesions of questionable significance to humans. Toxicol Pathol 1994; 22: 179-186.
2. AMES BN, GOLD LW: Too many rodent carcinogens: mitosenesis increases carcinogenesis. Science 1990; 249: 970-971.
3. ASHBY J: Determination of the genotoxic status of a chemical. Mutat Res 1991; 248: 221-231.
4. ASHBY J, MARROD RS: Detection of human carcinogens. Nature 1991; 352: 185-186.
5. ASHBY J, PATON D: The influence of chemical structure on the extent and sites of carcinogenesis for 522 rodent carcinogens and 55 different human carcinogen exposures. Mutat Res 1993; 286: 3-74.
6. ASHBY J, PURCHASE IFH: Will all chemicals be carcinogenic to rodents when adequately evaluated? Carcinogenesis 1993; 8: 489-495.
7. ASHBY J, TENNANT RW: Definitive relationships among chemical structure, carcinogenicity and mutagenicity for 301 chemicals tested by the U.S. NTP. Mutat Res 1991; 257: 229-306.
8. ASHBY J, TENNANT RW: Prediction of rodent carcinogenicity for 44 chemicals: results. Mutagenesis 1994; 9: 7-15.
9. ATTERWILL CK, FLACK JD: Endocrine toxicology. Cambridge University Press, 1992.
10. BARRETT JC: Prevention of environmentally related diseases. Environ Health Perspect 1994; 102: 812-813.
11. BLAAUBOER BJ, VAN HOLSTEIJN CWM, BLEUMINK R, et al.: The effect of beclobric acid and clofibric acid on peroxisomal ß-oxidation and peroxisome proliferation in primary cultures of rat, monkey and human hepatocytes. Biochem Pharmacol 1990; 40: 521-528.
12. BOORMAN GA, MARONPOT RR, EUSTIS SL: Rodent carcinogenicity bioassay: Past, present and future. Toxicol Pathol 1994; 22: 105-111.
13. BUTTERWORTH BE, SMITH-OLIVER T, EARLE L, et al.: Use of primary cultures of human hepatocytes in toxicology studies. Cancer Res 1989; 49: 1075-1084.
14. CLEMMESEN J, HJALGRIM-JENSEN S: Epidermiological studies of medically used druss. Arch Toxicol 1980; Suppl. 3: 19-25.
15. COHEN SM: Human relevance of animal carcinogenicity studies. Regul Toxicol Pharmacol 1995; 21: 75-80.
16. COUNTS JL, GOODMAN JI: Hypomethylation of DNA: An epigenetic mechanism involved in tumor promotion. Mol Carcinogen 1994; 11: 185-188.
17. COUNTS JL, GOODMAN JI: Principles underlying dose selection for, and extrapolation from, the carcinogen bioassay: Dose influences mechanism. Regul Toxicol Pharmacol 1995; 21: 418-421.
18. CPMP: The rules governing medicinal products in the European Community. Volume III. Guidelines on the quality, safety and efficacy of medicinal products for human use. Testing of medicinal products for their mutagenic potential. 1989.
19. DAVIES TS, MONRO A: The rodent carcinogenicity bioassay produces a similar frequency of tumor increases and decreases: Implications for risk assessment. Regul Toxicol Pharmarcol 1994; 20: 281-301.
20. DAVIES TS, MONRO A: Marketed human pharmaceuticals reported to be tumorigenic in rodents. J Amer College Toxicol 1995; 14: 90-107.
21. DE JONG G: Long-term health effects of aldrin and dieldrin. Toxicol Lett Supplement 1991; 1-206.
22. DOLL R: Are we winning the fight against cancer? An epidemiological assessment. Eur J Cancer 1990; 26: 500-508.
23. DOLL R, PETO R: The causes of cancer. J Natl Cancer Inst 1981; 66: 1191-1308.
24. DRINKWATER NR, GINSLER JJ: Genetic control of hepatocarcinogenesis in C57B1/6J and C3H/HeJ inbred mice. Carcinogenesis 1986; 7: 1701-1707.
25. ELCOMBE CR, MITCHELL AM: Peroxisome proliferation due to di(2-ethylhexyl) phthalate (DEHP): species differences and possible mechanisms. Environ Health Perspect 1986; 70: 211-219.
26. GOLD LS, BERNSTEIN L, MAGAW R, et al.: Interspecies extrapolation in carcinogenesis: prediction between rats and mice. Environ Health Perspect 1989; 81: 211-219.
27. GOLDSWORTHY TL, RECIO L, BROWN K, et al.: Symposium overview: Transgenic animals in toxicology. Fundam Appl Toxicol 1994; 22: 8-19.
28. GOODMAN JI: A rational approach to risk assessment requires the use of biological information: An analysis of the National Toxicology Program (NTP), final report of the advisory review by the NTP Board of Scientific Counselors. Regul Toxicol Pharmacol 1994; 19: 51-59.
29. GOODMAN JI, WARD JM, POPP JA, et al.: Mouse liver carcinogenesis: mechanisms and relevance. Fundam Appl Toxicol 1991; 17: 651-665.
30. GORELICK NJ: Overview of mutation assays in transgenic mice for routine testing. Environ Molecul Mutagen 1995; 25: 218-230.
31. GORI GB, FLAMM WG: How sick a patient? Report of a workshop on cancer risk assessment. Reg Toxicol Pharmacol 1991; 14: 215-222.
32. GRICE HC, BUREK JD: Age-associated (geriatric) pathology. Its impact on long-term toxicity studies. Curr Issues Toxicol 1984; 57-107.
33. HASEMAN JK: Patterns of tumor incidence in two-year cancer bioassay feeding studies in Fischer 344 rats. Fundam Appl Toxicol 1983; 3: 1-9.
34. HENDERSON BE, ROSS RK, PIKE MC: Toward the primary prevention of cancer. Science 1991; 254: 1131-1138.
35. HUFF J, HASEMAN J, RALL D: Scientific concepts, value. and significance of chemical carcinogenesis studies. Annu Rev Pharmacol Toxicol 1991; 31: 621-52.
36. IARC: Monographs on the evaluation of the carcinogenic risk of chemicals to humans. Some pharmaceutical drugs. International Agency for Research on Cancer. Lyon 1980; 24: 135-161.
37. ILSI: Fourth workshop on mouse liver tumors. Summary Report, Washington, DC. 1992.
38. ITO N, IMAIDA K: Strategy of research for cancer-chemoprevention. Teratogen Carcinogen Mutagen 1992; 12: 79-95.
39. ITO N, SHIRAI T, HASEGAWA R: Medium-term bioassays for carcinogens. In: VAINIO H, MAGEE PN, MCGREGOR DB, et al. (eds.): Mechanisms of carcinogenesis in risk identification. IARC Lyon 1992; 353-388.
40. LUCIER GW: Receptor-mediated carcinogenesis. In: VAINIO H, MAGEE P, MCGREGOR D, et al. (eds.): Mechanisms of carcinogenesis in risk identification. IARC Lyon, Sci Publ No. 116 1992; 87-112.
41. MACDONALD JS, LANKAS GR, MORRISSEY RE: Toxicokinetic and mechanistic considerations in the interpretation of the rodent bioassay. Toxicol Pathol 1994; 22: 124-140.
42. MARSELOS M, VAINIO H: Carcinogenic properties of pharmaceutical agents evaluated in the IARC Monographs programme. Carcinogenesis 1991; 12: 1751-1756.
43. MASON JM, LANGENBACH R, SHELBY MD, et al.: Ability of shortterm tests to predict carcinogenesis in rodents. Ann Rev Pharmacol Toxicol 1990; 30: 149-168.
44. MCAUSLANE JAN, LUMLEY CE: Carcinogenicity studies for pharmaceuticals: Classification and misclassification. Drug Info J 1993; 27: 509-514.
45. MCCLAIN RM: Mechanistic considerations in the regulation and classification of chemical carcinogens. In: KOTSONIS FN, MACKEY M, HJELLE J (eds.): Nutritional Toxicology. Raven Press Ltd New York 1994; 273-304.
46. MHW: Guideline for toxicity studies required for applications for approval to manufacture drugs. Mutagenicity study. Japanese Ministry of Health and Welfare 1989.
47. MONRO A: How useful are chronic (life-span) toxicology studies in rodents in identifying pharmaceuticals that pose a carcinogenic risk to humans? Adverse Drug React Toxicol Rev 1993; 12: 5-34.
48. MONRO A: The paradoxical lack of interspecies correlations between plasma concentrations and chemical carcinogenicity. Regul Toxicol Pharmacol 1993; 18: 115-135.
49. MONRO A, DAVIES TS: High dose levels are not necessary in rodent studies to detect human carcinogens. Cancer Lett 1993; 75: 183-194.
50. MONRO A, MORDENTI J: Expression of exposure in negative carcinogenicity studies: Dose/body weight, dose/body surface area, or plasma concentrations? Toxicol Pathol 1995; 23: 187-198.
51. NEUMANN F: Early indicators for carcinogenesis in sex-hormone-sensitive organs. Mutat Res 1991; 248: 341-356.
52. ODA T, TSUDA H, SCARPA A, et al.: p53 gene mutation spectrum in hepatocellular carcinoma. Cancer Res 1992; 52: 6358-6364.
53. OLSEN JH, BOICE JJD, JENSEN PA, et al.: Cancer among epileptic patients exposed to anticonvulsant drugs. J Natl Cancer Inst 1989; 81: 803-808.
54. PARZEFALL W, ERBER E, SEDIVY R, et al.: Testing for induction of DNA synthesis in human hepatocyte primary cultures by rat liver tumor promoters. Cancer Res 1991; 51: 1143-1147.
55. POPP JA: Mouse liver neoplasia. Current perspectives. Hemisphere Publishing Corporation, New York, 1984.
56. PROVOST GS, KRETZ PL, HAMNER RT, et al.: Transgenic systems for in vivo mutation analysis. Mutat Res 1993; 288: 133-150.
57. PURCHASE IFH: Current knowledge of mechanisms of carcinogenicity: Genotoxins versus non-genotoxins. Human Exper Toxicol 1994; 13: 17-28.
58. SALSBURG D: The life-time feeding study in mice and rats - an examination of its validity as a bioassay for human carcinogens. Fundam Appl Toxicol 1983; 3: 63-67.
59. SHELBY MD, ZEIGER E: Activity of human carcinogens in the Salmonella and rodent bone-marrow cytogenetics tests. Mutat Res 1990; 234: 257-261.
60. SHIRAI T, FUKUSHIMA S, OHSHIMA M, et al.: Effects of butylated hydroxyanisole, butylated hydroxytoluene, and NaCl on gastric carcinogenesis initiated with N-methyl-N-nitro-N-nitrosoguanidine in F344 rats. J Natl Cancer Inst 1984; 72: 1189-1198.
61. STEVENSON DE, MCCLAIN RM, POPP JA, et al. (eds.): Mouse Liver Carcinogenesis; Mechanisms and Species Comparisons., Wiley-Liss, New York 1990.
62. TENNANT RW: Stratification of rodent carcinogenicity bioassay results to reflect relative human hazard. Mutat Res 1993; 286: 111-118.
63. TENNANT RW, SPALDING J, STASIEWICZ S, et al.: Prediction of the outcome of rodent carcinogenicity bioassay currently being conducted on 44 chemicals by the National Toxicology Program. Mutagenesis 1990; 5: 3-14.
64. TENNANT RW, ZEIGER E: Genetic Toxicology: Current status of methods of carcinogen identification. Environ Health Perspect 1993; 100: 307-315.
65. TOMATIS L (ed.): Cancer: Causes, occurrence and control. IARC Lyon Sci Publ No. 100 1990.
66. TOMATIS L, AITIO A, WILBOURN J, et al.: Human carcinogens identifed so far. Jap J Cancer Res 1989; 80: 795-807.
67. VAINIO H, MAGEE PN, MCGREGOR DB, et al. (eds.): Mechanisms of carcinogenesis in risk identification. IARC Lyon Sci Pub No. 116 1992; 9-54.
68. WATERS MD, STACK HF, JACKSON MA, et al.: Hazard identification: Efficiency of short-term tests in identifying germ cell mutagens and putative nongenotoxic carcinogens. Environ Health Perspect 1993; 101: 61-72.
69. WEISBURGER JH, HORN CL: The causes of cancer. In: MURPHY GP, LAWRENCE W (eds.): Textbook of Clinical Oncology. Am Cancer Soc Inc, Atlanta GA, 1994; 80-98.
70. WILLIAMS GM, WEISBURGER J: Chemical carcinogenesis. In: AMDUR MO, DOULL J, KLAASSEN CD (eds.): CASARETT and DOULL'S Toxicology. Pergamon Press New York 4th Ed. 1991; 127-200.