Comparison of site-specific and overall tumor incidence analyses for 81 recent National Toxicology Program carcinogenicity studies. 1986

J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell

Eighty-one recent carcinogenicity studies carried out by the National Toxicology Program (NTP) were evaluated to determine how the utilization of statistical analyses based on the proportion of animals with primary tumors (all sites) or the proportion of animals with malignant neoplasms (all sites) affected the interpretation of the data compared to analyses of site-specific effects. Utilizing site-specific analyses, the NTP concluded that 45 of the 81 studies (56%) showed carcinogenic responses, 7 (9%) produced equivocal effects, and 29 (36%) showed no evidence of carcinogenicity. An analysis of tumors at all sites often resulted in site-specific carcinogenic responses going undetected. Less than half of the 45 carcinogens identified as producing site-specific carcinogenic responses showed a significant increase in the incidence of primary tumors (22 chemicals) or malignant tumors (21 chemicals). Among the 29 chemicals interpreted as not carcinogenic based on site-specific effects, only two showed significant increases in overall tumor incidence. Two major problems are associated with an evaluation based on overall (all sites) tumor rates: The pooling of various tumor types reduces study sensitivity for detecting chemically related increases in site-specific tumor incidences, and the biological relevance of combining the incidences of tumors of varying morphologies and topographies is questionable. Most national and international guidelines for studying chemicals for carcinogenicity in rodents (or in humans) emphasize site-specific effects. Thus, despite purported advantages of analyses based on overall tumor rates (e.g., simplicity; reducing concerns regarding false positive results) primary emphasis should continue to be on site-specific analyses.

UI MeSH Term Description Entries
D008297 Male Males
D008815 Mice, Inbred Strains Genetically identical individuals developed from brother and sister matings which have been carried out for twenty or more generations, or by parent x offspring matings carried out with certain restrictions. All animals within an inbred strain trace back to a common ancestor in the twentieth generation. Inbred Mouse Strains,Inbred Strain of Mice,Inbred Strain of Mouse,Inbred Strains of Mice,Mouse, Inbred Strain,Inbred Mouse Strain,Mouse Inbred Strain,Mouse Inbred Strains,Mouse Strain, Inbred,Mouse Strains, Inbred,Strain, Inbred Mouse,Strains, Inbred Mouse
D009374 Neoplasms, Experimental Experimentally induced new abnormal growth of TISSUES in animals to provide models for studying human neoplasms. Experimental Neoplasms,Experimental Neoplasm,Neoplasm, Experimental
D009928 Organ Specificity Characteristic restricted to a particular organ of the body, such as a cell type, metabolic response or expression of a particular protein or antigen. Tissue Specificity,Organ Specificities,Specificities, Organ,Specificities, Tissue,Specificity, Organ,Specificity, Tissue,Tissue Specificities
D011916 Rats, Inbred F344 An inbred strain of rat that is used for general BIOMEDICAL RESEARCH purposes. Fischer Rats,Rats, Inbred CDF,Rats, Inbred Fischer 344,Rats, F344,Rats, Inbred Fisher 344,CDF Rat, Inbred,CDF Rats, Inbred,F344 Rat,F344 Rat, Inbred,F344 Rats,F344 Rats, Inbred,Inbred CDF Rat,Inbred CDF Rats,Inbred F344 Rat,Inbred F344 Rats,Rat, F344,Rat, Inbred CDF,Rat, Inbred F344,Rats, Fischer
D002273 Carcinogens Substances that increase the risk of NEOPLASMS in humans or animals. Both genotoxic chemicals, which affect DNA directly, and nongenotoxic chemicals, which induce neoplasms by other mechanism, are included. Carcinogen,Oncogen,Oncogens,Tumor Initiator,Tumor Initiators,Tumor Promoter,Tumor Promoters,Initiator, Tumor,Initiators, Tumor,Promoter, Tumor,Promoters, Tumor
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia

Related Publications

J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
August 1987, Environmental health perspectives,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
January 1999, Toxicologic pathology,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
July 1996, Fundamental and applied toxicology : official journal of the Society of Toxicology,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
January 1984, Journal of toxicology and environmental health,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
April 2008, Toxicologic pathology,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
January 1989, Journal of toxicology and environmental health,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
January 1984, Drug metabolism reviews,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
January 1989, Environmental and molecular mutagenesis,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
January 1989, Toxicologic pathology,
J K Haseman, and E C Tharrington, and J E Huff, and E E McConnell
September 1986, Cancer research,
Copied contents to your clipboard!