Recombinant rat and mouse growth hormones: Risk assessment of carcinogenic potential in 2-year bioassays in rats and mice

Toxicological Sciences

Volumn 97, Issue 2, 2007, Pages 548-561

  Farris, Georgia M ^a   Miller, Glen K ^a   Wollenberg, Gordon K ^a   Molon Noblot, Sylvain ^b   Chan, Christine ^a   Prahalada, Srinivasa ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Dohme Chibret Centre de Recherche Riom   (France)

Author keywords

Endocrine; Pharmaceuticals; Risk assessment

Indexed keywords

GROWTH HORMONE; RECOMBINANT GROWTH HORMONE; SOMATOMEDIN C;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CANCER INCIDENCE; CARCINOGENICITY; CELL POPULATION; CONTROLLED STUDY; DRUG EXPOSURE; DRUG TOLERABILITY; FEMALE; GROWTH HORMONE BLOOD LEVEL; HORMONE BLOOD LEVEL; HYPOPHYSIS CELL; LONGEVITY; MALE; MALIGNANT NEOPLASTIC DISEASE; MOUSE; NONHUMAN; RAT; RISK ASSESSMENT; WEIGHT GAIN;

ANIMALS; BODY WEIGHT; CARCINOGENICITY TESTS; CARCINOGENS; FEMALE; GROWTH; GROWTH HORMONE; HYPOPHYSECTOMY; INSULIN-LIKE GROWTH FACTOR I; MALE; MICE; MICE, INBRED ICR; MICRONUCLEUS TESTS; ORGAN SIZE; PITUITARY GLAND; RATS; RATS, SPRAGUE-DAWLEY; RATS, WISTAR; RECOMBINANT PROTEINS; RISK ASSESSMENT;

MUS; RATTUS; RODENTIA;

EID: 34447570828     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfm059     Document Type: Article

References (22)

1. Cahill, M., Satiritz, S., Keuler, J., and Patrick, D. H. (1995). Insulin-like growth-factor-I (Igf-1) by extraction and radioimmunoassay in the rodent and canine species. Clin. Chem. 41, S161.
2. Gharib, H.,Cook, D.M.,Saenger,P.H.,Bengtsson, B. A.,Feld, S.,Nippoldt, T.B., Rodbard, H. W., Seibel, J. A., Vance, M. L., Zimmerman, D., et al. (2003). American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in adults and children - 2003 update. Endocr. Pract. 9(1), 64-76.
3. Harter, H. L. (1957). Error rates and sample sizes for range tests in multiple comparisons. Biometrics 13, 511-536.
4. Heyse, J. F., and Rom, D. (1988). Adjusting for multiplicity of statistical tests in the analysis of carcinogenicity studies. Biom. J. 30, 883-896.
5. Keenan, K. P., Soper, K. A., Smith, P. F., Ballam, G. C., and Clark, R. L. (1995). Diet, overfeeding, and moderate dietary restriction in control Sprague-Dawley rats. 1. Effects on spontaneous neoplasms. Toxicol. Pathol. 23, 269-286.
6. Koneff, A. A., Moon, H. D., Simpson, M. E., Li, C. H., and Evans, H. M. (1951). Neoplasms in rats treated with pituitary growth hormone. IV. Pituitary gland. Cancer Res. 11, 113-117.
7. Laroque, P., Molon-Noblot, S., Prahalada, S., Stabinski, L. G., Hoe, C. M., Peter, C. P., Duprat, P., and van Zwieten, M. J. (1998). Morphological changes in the pituitary gland of dogs chronically exposed to exogenous growth hormone. Toxicol. Pathol. 26, 201-206.
8. Leung, F. C., Jones, B., Steelman, S. L., Rosenblum, C. I., and Kopchick, J. J. (1986). Purification and physiochemical properties of a recombinant bovine growth-hormone produced by cultured murine fibroblasts. Endocrinology 119, 1489-1496.
9. Mandel, S., Moreland, E., Nichols, V., Hanna, C., and Lafranchi, S. (1995). Changes in insulin-like growth-factor-I (Igf-I), Igf-binding protein-3, growth-hormone (Gh)-binding protein, erythrocyte Igf-I receptors, and growth-rate during Gh treatment. J. Clin. Endocrinol. Metab. 80, 190-194.
10. Mantel, N. (1980). Assessing laboratory evidence for neoplastic activity. Biometrics 36, 381-399.
11. Moon, H. D., Simpson, M. E., Li, C. H., and Evans, H. M. (1950a). Neoplasms in rats treated with pituitary growth hormone. I. Pulmonary and lymphatic tissues. Cancer Res. 10, 297-308.
12. Moon, H. D., Simpson, M. E., Li, C. H., and Evans, H. M. (1950b). Neoplasms in rats treated with pituitary growth hormone. III. Reproductive organs. Cancer Res. 10, 549-556.
13. Ogilvy-Stuart, A. L., and Gleeson, H. (2004). Cancer risk following growth hormone use in childhood - Implications for current practice. Drug Saf. 27, 369-382.
14. Peto, R., Pike, M. C., Day, N. E., Gray, R. G., Lee, P. N., Parish, S., Peto, J., Richards, S., and Wahrendorf, J. (1980). Guidelines for simple, sensitive significance tests for carcinogenic effects in long-term animal experiments. IARC Monogr. Eval. Carcinog. Risk Chem. Hum. Suppl. (2 Suppl.), 311-426.
15. Sanyal, G., MarquisOmer, D., Watson, S. K., Chan, C. P., Rubenstein, L. J., Prahalada, S., and Volkin, D. B. (1997). Formulation and biophysical characterization of recombinant rat and mouse growth hormones. Abstr. Pap. Am. Chem. Soc. 213, 74-IEC.
16. Sonntag, W. E., Steger, R. W., Forman, L. J., and Meites, J. (1980). Decreased pulsatile release of growth-hormone in old male-rats. Endocrinology 107, 1875-1879.
17. Sperling, M. A., Saenger, P. H., Hintz, R., Wilson, T., and Rose, S. R. (2002). Special editorial: Growth hormone treatment and neoplasia - Coincidence or consequence? J. Clin. Endocrinol. Metab. 87, 5351-5352.
18. Swerdlow, A. J., Higgins, C. D., Adlard, P., and Preece, M. A. (2002). Risk of cancer in patients treated with human pituitary growth hormone in the UK, 1959-85: A cohort study. Lancet 360, 273-277.
19. Toogood, A. A., Holmes, S. J., and Shalet, S. M. (1996). Monitoring growth hormone replacement therapy. In Growth Hormone in Adults: Physiological and Clinical Aspects (A. Juul and J. O. L. Jørgensen, Eds.), pp. 186-198. Cambridge University Press, Cambridge, NY.
20. Tukey, J. W., Ciminera, J. L., and Heyse, J. F. (1985). Testing the statistical certainty of a response to increasing doses of a drug. Biometrics 41, 295-301.
21. Watanabe, S., Mizuno, S., Oshima, L. H., Tsunematsu, Y., Fujimoto, J., and Komiyama, A. (1993). Leukemia and other malignancies among GH users. J. Pediatr. Endocrinol. 6, 99-108.
22. Zhou,W. C., Bibila, T., Glazomitsky, K., Montalvo, J., Chan, C., DiStefano, D., Munshi, S., Robinson, D., Buckland, B., and Aunins, J. (1996). Large scale production of recombinant mouse and rat growth hormone by fed-batch GS-NSO cell cultures. Cytotechnology 22 239-250.