Quantitative Estimation and Prediction of Human Cancer Risks

, by S. Moolgavkar; D. Krewski; L. Zeise; E. Cardis; H. MÃ¸ller

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ISBN: 9789283221319 | 9283221311
Cover: Paperback
Copyright: 8/12/1999

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This volume assesses formal methods for the quantitative estimation and prediction of human cancer risks. Quantitative estimates of cancer risk can be expressed in different ways. In some cases estimates of risk under conditions prevailing in the original data are of primary interest; in others predictions of risk under other conditions are required. Estimates of risk may be based on empirical models that provide a reasonable description of the available data or on models developed on the basis of plausible assumptions about the mechanisms of carcinogenesis. Throughout this volume established scientific principles of carcinogenesis are used to support methods proposed for the quantitative estimation and prediction of risk.

Foreword

Contributors

xii

Acknowledgements

xiii

Quantitative estimation and prediction of human cancer risk: its history and role in cancer prevention

(10)

A.J. McMichael

A. Woodward

Introduction

(1)

Historical background

(1)

Definitions of terms and concepts

(2)

Regulation and control of cancer risks

(2)

Risk prediction

(1)

Conclusions

(3)

References

(2)

Quantitative estimation and prediction of cancer risk: review of existing activities

(50)

L. Zeise

E. Cardis

K. Hemminki

M. Schwarz

Introduction

(1)

QEP by international bodies using standardized approaches

(6)

World Health Organization

(1)

Drinking-water

(1)

Ambient air

(1)

Food residues and additives

(1)

General environmental evalutions

(1)

Developments in the practice of QEP at WHO

(1)

International bodies that assess radiation risks

(1)

Other international bodies

(1)

QEP by national institutions using standardized approaches

(7)

Netherlands

(1)

USA

(1)

Default risk prediction

(1)

Use of QEPs

(1)

Canada

(2)

Norway

(1)

United Kingdom

(1)

Germany

(1)

Denmark

(1)

Standard approaches to QEP for carcinogens

(3)

Attempts to improve QEP

(12)

``Biologically based'' approaches

(1)

Integrated modelling of physiology, pharmacokinetics, pharmacodynamics and cell dynamics: 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)

(1)

Mechanistic modelling assuming cancer induced by chronic irritation: saccharin

(1)

Use of information on DNA cross-links as a measure of dose: formaldehyde

(1)

Uncertainty and variability analysis in PBPK models: methylene chloride and perchloroethylene

(3)

Meta-analyses of epidemiological data: ionizing radiation and environmental tobacco smoke

(1)

Ionizing radiation

(1)

Environmental tobacco smoke

(1)

Experimental and epidemiological efforts to improve estimates of benzene cancer potency

(1)

Modelling of benzene pharmacokinetics

(1)

Cohort exposure reconstruction and related dose-response evaluations

(1)

Predictions of cancer potency without cancer bioassay or epidemiological data

(1)

Ethylene cancer potency inferred from metabolite ethylene oxide

(1)

Use of toxicity equivalency factors: complex mixtures

(1)

Conclusions

(21)

References

(19)

Principles of the epidemiological approach to QEP

(14)

S. Moolgavkar

H. Moller

A. Woodward

Introduction

(1)

Measures of disease frequency and measures of effect

(2)

Confounding

(1)

Types of epidemiological study

(4)

Cohort studies

(2)

Case-control studies

(1)

Ecological studies

(1)

Data analysis

(1)

Combined and meta-analyses

(2)

Conclusions

(4)

References

(4)

Measurement of exposure and outcome in epidemiological studies used for quantitative estimation and prediction of risk

(28)

B. Armstrong

P. Boffetta

Introduction

(1)

Making the right exposure measurements

(3)

Nature of exposure measurements

(1)

Measurement of dose

(1)

Measurement of variation in exposure with time

(2)

Effects of exposure measurement error on QEP

(3)

Effect of exposure measurement error on the dose-response relationship

(1)

Analytical epidemiological studies

(1)

Ecological studies

(1)

Measurement error in confounding

(1)

Analytical epidemiological studies

(1)

Ecological studies

(1)

Example of effects of exposure measurement error on QEP

(1)

Conclusions

(1)

Prevention of exposure measurement error

(4)

Quality in the design of measurement instruments

(2)

Quality control in making and using measurements

(1)

Other factors

(1)

Control of the effects of exposure measurement error

(4)

Multiple measures of exposure

(1)

Adjustment of study results for the effects of measurement error

(2)

Control of a covariate related to measurement error

(1)

Resources for the control of exposure measurement error

(1)

Error in the measurement of outcome

(7)

Death from cancer

(1)

Incidence of cancer

(1)

Preneoplastic lesions

(1)

Molecular markers of early carcinogenic effect

(1)

Sources, measurement and prevention of error in the measurement of outcome

(3)

Effect of error in measurement of outcome on the dose-response relationship

(1)

Conclusions

(6)

References

(6)

Long-and medium-term carcinogenicity studies in animals and short-term genotoxicity tests

103

(28)

V. Feron

M. Schwarz

K. Hemminki

D. Krewski

General principles

103

(1)

Design and analysis of cancer bioassays

104

(10)

Long-term studies

104

(1)

Design and conduct

104

(3)

Statistical analysis

107

(1)

Medium-term studies

108

(1)

Mouse skin

109

(1)

Liver

110

(2)

Other organs

112

(2)

Transgenic animals

114

(2)

Use of biomarkers

116

(1)

Short-term tests

117

(1)

Conclusions

118

(13)

References

119

(12)

Empirical approaches to risk estimation and prediction

131

(48)

D. Krewski

E. Cardis

L. Zeise

V. Feron

Introduction

131

(1)

Modelling epidemiological data

132

(8)

Cohort studies

133

(3)

Case-control studies

136

(1)

Generalized linear models

137

(1)

Choice of model from

137

(2)

Other measures of risk

139

(1)

Modelling toxicological data

140

(5)

Quantal-response models

140

(2)

Models of time to response

142

(3)

Patterns of exposure and risk

145

(3)

Carcinogenic potency

148

(5)

The TD50

148

(2)

Variation in carcinogenic potency

150

(1)

Correlation between TD50 and other measures of toxicity

151

(1)

Numerical ranking systems

152

(1)

Joint exposures and carcinogenic mixtures

153

(5)

Modelling the risk of joint exposures

154

(1)

Theoretical predictions of the risks of joint exposures

155

(1)

Empirical studies of the risks of joint exposures

156

(1)

Modelling joint exposures

157

(1)

Risk prediction

158

(3)

Extrapolation from high to low doses

158

(1)

Interspecies extrapolation

159

(2)

Variability, uncertainty and sensitivity analyses

161

(3)

Sources and characterizations of variability

162

(1)

Sources and characterizations of uncertainty

163

(1)

Sensitivity analysis

164

(1)

Summary and conclusions

164

(15)

References

167

(12)

Mechanisms of carcinogenesis and biologically based models for estimation and prediction of risk

179

(60)

S. Moolgavkar

D. Krewski

M. Schwarz

Introduction

179

(1)

Mechanisms of carcinogenesis

180

(7)

Introduction

180

(1)

Oncogenes and tumour-suppressor genes

180

(2)

Proliferation and terminal differentiation of cells

182

(1)

Action of environmental agents

183

(1)

Metabolic factors

183

(1)

DNA binding

184

(1)

Mutations in critical genes

184

(1)

Cell proliferation

185

(1)

Classification of carcinogenic agents

186

(1)

Interindividual variation

187

(3)

Genetic predisposition

187

(1)

Interindividual and interspecies variation in carcinogen metabolism

187

(2)

Interindividual variation in DNA repair

189

(1)

Interspecies variation

190

(1)

Biologically based dose-response models

190

(17)

Introduction

190

(3)

The Armitage-Doll multistage model

193

(3)

The two-mutation model

196

(2)

The hazard function: analysis of incidence data

198

(1)

Radon and lung cancer in rats

199

(1)

Reanalysis of the Colorado Plateau uranium miners' data

200

(1)

Analysis of intermediate lesions

201

(1)

Rodent hepatocarcinogenesis

202

(2)

Initiation-promotion in mouse skin

204

(1)

Joint analyses of premalignant and malignant lesions

205

(1)

Limitations of biologically based models

205

(1)

Data requirements

206

(1)

Pharmacokinetic modelling

207

(6)

Development of a PBPK model

208

(1)

Mathematical description of a PBPK model

208

(1)

Selection of model compartments.

209

(1)

Determination of physiological, biochemical and metabolic parameters

210

(1)

Physiological parameters

210

(1)

Partition coefficients.

210

(1)

Metabolic parameters.

211

(1)

Tissue dosimetry

211

(1)

Applications

212

(1)

Uncertainty, variability and sensitivity analyses

212

(1)

Summary and conclusions

213

(1)

Receptor-binding models

213

(2)

Summary and conclusions

215

(2)

Appendix

A.1 The Armitage-Doll model

217

(1)

A.2 The two-mutation model

217

(22)

A.2.1 The hazard function

217

(2)

A.2.2 Number and size distribution of intermediate foci

219

(2)

References

221

(18)

Review of specific examples of QEP

239

(66)

E. Cardis

L. Zeise

M. Schwarz

S. Moolgavkar

Introduction

239

(1)

Radon and lung cancer

240

(17)

Introduction

240

(1)

Sources of data

240

(1)

Occupational epidemiological studies

240

(4)

Animal studies

244

(1)

Residential radon studies

244

(3)

Mechanistic studies

247

(1)

Cofactors and effect modifiers

248

(1)

Lung dosimetry

249

(1)

Empirical approach to QEP

249

(1)

BEIR IV

249

(1)

Joint analyses of 11 studies on miners

250

(2)

Mechanistic modelling

252

(4)

Comparison of QEP results

256

(1)

Remaining uncertainties, needs for the future

256

(1)

Aflatoxins and liver cancer

257

(19)

Introduction

257

(1)

Epidemiological studies

257

(1)

Correlation studies

257

(3)

Case-control studies

260

(1)

Cohort studies

260

(4)

Experimental data

264

(1)

Animal bioassay

264

(1)

Pharmacokinetics

264

(1)

DNA-adducts

265

(1)

Target gene

266

(1)

Animal models of aflatoxin and HBV interaction

267

(1)

Review of risk assessments

267

(2)

Assessments based on the correlation studies

269

(1)

Analyses based on the Guangxi, China cohort data

269

(4)

Discussion

273

(1)

Reliability of exposure estimates in epidemiological studies

273

(1)

Impact of hepatitis B virus on aflatoxin risk

273

(1)

Genetically determined differences in human susceptibility

274

(1)

Shape of the dose-response curve

275

(1)

Impact of background exposures

275

(1)

Research needs

275

(1)

2,3,7,8-Tetrachlorodibenzo-para-dioxin (TCDD)

276

(29)

Introduction

276

(1)

Experimental data

276

(1)

Animal bioassay

276

(2)

Pharmacokinetic data

278

(1)

Initiation-promotion studies

278

(1)

Short-term tests

279

(1)

Mechanistic aspects of TCDD action

279

(2)

Epidemiological studies

281

(2)

Risk assessment

283

(1)

Conclusions

284

(1)

References

284

(21)

Future perspectives, unresolved issues and research needs

305

(13)

S. Moolgavkar

A. Woodward

D. Krewski

E. Cardis

L. Zeise

Introduction

305

(1)

An example: the case of dioxin (TCDD)

305

(1)

Future perspective and research needs in epidemiology

306

(5)

Genetic and environmental factors in cancer epidemiology

306

(1)

Exposure/dose assessment

307

(1)

Biomarkers of exposure and surrogate end-points

308

(1)

Interindividual variation in susceptibility to carcinogen exposure

309

(2)

Future perspectives and research needs in toxicological studies

311

(2)

Intermediate lesions

311

(1)

Cell proliferation kinetics

311

(1)

Statistical considerations

312

(1)

Future perspectives and research needs for biologically based models of carcinogenesis

313

(4)

The bioassay

317

(1)

Conclusions

317

(1)

References

318

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Quantitative Estimation and Prediction of Human Cancer Risks

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