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Some Antiviral and Antineoplastic Drugs, and Other Pharmaceutical Agents
IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 76
IARC Working Group on the Evaluation of Carcinogenic Risks to Humans.
This monograph evaluates the carcinogenic risks to humans posed by the use of four antiretroviral agents, four DNA topoisomerase II inhibitors used in the treatment of cancer, and an additional three pharmaceutical agents (hydroxyures, phenolphthalein, and vitamin K substances). The volume marks the first IARC evaluation of nucleoside analogs that act as antiviral agents. The evaluation responds in part to recent findings that zidovudine (AZT), an effective antiretroviral agent now being given to pregnant HIV-infected women to prevent maternal-to-fetal transmission of the virus, is a transplacental carcinogen in mice.
The opening monograph evaluates the carcinogenicity to humans of the antiretroviral nucleoside analogs zidovudine (AZT), zalcitabine (ddC), and didanosine (ddI), and the antiherpesvirus drug aciclovir. Of these, aciclovir and didanosine could not be classified on the basis of available data. For zidovudine, transplacental administration to mice resulted in an increased incidence and multiplicity of lung and liver tumours and in an increased incidence of female reproductive tract tumours in one study, but not in another involving treatment at a lower dose. Despite observation of toxic effects in some studies of humans, human carcinogenicity data were judged to provide inadequate evidence of carcinogenicity in humans. Zidovudine was classified as possibly carcinogenic to humans. Similar weaknesses in human carcinogenicity data for zalcitabine, which consistently induces thymic lymphomas in mice, resulted in its classification as possibly carcinogenic to humans.
The second monograph evaluates four DNA topoisomerase II inhibitors: etoposide, teniposide, mitoxantrone, and amsacrine. Of these, etoposide - one of the most widely used and effective cytotoxic drugs in combination therapy - was classified as probably carcinogenic to humans, and etoposide in combination with cisplatin and bleomycin was judged to be carcinogenic to humans. Teniposide was classified as probably carcinogenic to humans, and mitoxantrone and amsacrine were classified as possibly carcinogenic to humans.
Of the three pharmaceutical agents evaluated in the final monograph, hydroxyurea, which is widely used in cancer treatment and, increasingly, in combination with didanosine in HIV infection, could not be classified. Phenolphthalein, a widely used laxative now being withdrawn from the market in many countries because of toxicological concerns, was classified as possibly carcinogenic. Vitamin K substances could not be classified on the basis of available evidence.
Contents
Corrigenda to the IARC Monographs are published online at: http://monographs.iarc.fr/ENG/Publications/corrigenda.php
LIBRARY CATALOGUING DATA
This publication represents the views and expert opinions of an IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, which met in Lyon, 12–19 October 1999
Lyon, France - 2000
IARC MONOGRAPHS
In 1969, the International Agency for Research on Cancer (IARC) initiated a programme on the evaluation of the carcinogenic risk of chemicals to humans involving the production of critically evaluated monographs on individual chemicals. The programme was subsequently expanded to include evaluations of carcinogenic risks associated with exposures to complex mixtures, life-style factors and biological and physical agents, as well as those in specific occupations.
The objective of the programme is to elaborate and publish in the form of monographs critical reviews of data on carcinogenicity for agents to which humans are known to be exposed and on specific exposure situations; to evaluate these data in terms of human risk with the help of international working groups of experts in carcinogenesis and related fields; and to indicate where additional research efforts are needed.
The lists of IARC evaluations are regularly updated and are available on Internet: http://www.iarc.fr/, under Publications.
This project was supported by Cooperative Agreement 5 UO1 CA33193 awarded by the United States National Cancer Institute, Department of Health and Human Services. Additional support has been provided since 1986 by the European Commission, since 1993 by the United States National Institute of Environmental Health Sciences and since 1995 by the United States Environmental Protection Agency through Cooperative Agreement Assistance CR 824264.
- ©International Agency for Research on Cancer, 2000
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- Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention.
- All rights reserved. Application for rights of reproduction or translation, in part or in toto, should be made to the International Agency for Research on Cancer.
IARC Library Cataloguing in Publication Data
Some antiviral and antineoplastic drugs, and other pharmaceutical agents /
- IARC Working Group on the Evaluation of Carcinogenic Risks to Humans (2000 : Lyon, France).
- (IARC monographs on the evaluation of carcinogenic risks to humans ; 76)
- 1. Carcinogens – congresses 2. Drugs – congresses
- I. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
- II. Series
- ISBN 92 832 1276 2 (NLM Classification: W1)
- ISSN 1017-1606
- PRINTED IN FRANCE
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