Mazue G, Combes M
Bull Cancer. 1983;70(1):26-30.
In past years, health authorities have exempted anti-neoplastic agents from undergoing carcinogenesis tests. However, in view of increasing knowledge of this therapeutic family and of patients' increased life expectancy, toxicologists are having to reconsider the problem from both ethical and scientific points of view. Analysis of data has established a correlation between mutagenic activity of these molecules, carcinogenic activity in the animal and carcinogenic activity in man. For this reason, studies in laboratory animals are of interest at the present time. Assessment of the carcinogenic activity of anti-neoplastic agents in animals must take into account the chemical structure of the drug. The experiments to be carried out are: either in vitro, short term tests aimed to detect genotoxic drugs by mutagenesis tests, or limited in vivo tests, in order to determine the promoting or initiating character of these drugs. However, the obtention of negative results with the latter tests does not exclude the necessity of long term tests. Whatever the results obtained during these experiments, the decision to stop or to continue the development of an anti-neoplastic agent does not belong exclusively to the toxicologist, who can assess the risk, but not the potential benefice.
过去几年，卫生当局已豁免抗肿瘤药物进行致癌性试验。然而，鉴于对这一治疗药物类别了解的增加以及患者预期寿命的延长，毒理学家不得不从伦理和科学角度重新审视这个问题。数据分析已证实这些分子的致突变活性、在动物体内的致癌活性与在人体中的致癌活性之间存在关联。因此，目前在实验动物身上进行的研究很有意义。评估抗肿瘤药物在动物体内的致癌活性必须考虑药物的化学结构。要进行的实验有：要么是体外短期试验，旨在通过诱变试验检测具有基因毒性的药物，要么是有限的体内试验，以确定这些药物的促癌或致癌特性。然而，后者试验得到阴性结果并不排除进行长期试验的必要性。无论这些实验取得何种结果，决定停止或继续开发一种抗肿瘤药物并不完全取决于毒理学家，毒理学家可以评估风险，但无法评估潜在益处。
