Deschl Ulrich, Kittel Birgit, Rittinghausen Susanne, Morawietz Gerd, Kohler Manfred, Mohr Ulrich, Keenan Charlotte
Bayer AG, Pharma Research Center, Wuppertal, Germany.
Toxicol Pathol. 2002 Jan-Feb;30(1):80-7. doi: 10.1080/01926230252824743.
Historical control tumor data are useful in the interpretation of long-term rodent carcinogenicity bioassays, especially to assess the occurrence of rare tumors and marginally increased tumor incidences. The major prerequisites to compare historical control data with studies under evaluation are the validity and consistency of the respective databases. The RITA (Registry of Industrial Toxicology Animal-data) database for historical data of tumors and pre-neoplastic lesions collects data according to highly standardized procedures including tissue sampling and trimming, histopathology according to internationally harmonized nomenclature and diagnostic criteria, and peer review. All lesions that are entered are unanimously diagnosed according to IARC (Intermational Agency for Research on Cancer)/WHO criteria. The validity of data is additionally confirmed by a complete peer review performed by a database pathologist. Equivocal diagnoses and selected cases are additionally submitted to a panel of RITA pathologists. In the RITA database, there are currently 10,896 rats from 106 studies with more than 17,604 primary tumors and 16,551 pre-neoplastic lesions. The RITA database for historical control data for Wistar and Sprague Dawley rats as well as for different mouse strains is briefly described. Based upon RITA background data, the survival rate of Wistar rats has been consistent over a period of 10 years. The occurrence of tumor-bearing animals also shows a stable percentage over a decade. Additionally, examples of how historical control data may support carcinogenic risk assessment in cases of rare tumors or marginally increased incidences of tumors and pre-neoplastic lesions are given.
历史对照肿瘤数据在长期啮齿动物致癌性生物测定的解释中很有用，特别是在评估罕见肿瘤的发生情况和肿瘤发生率略有增加的情况时。将历史对照数据与正在评估的研究进行比较的主要前提是各个数据库的有效性和一致性。RITA（工业毒理学动物数据登记处）肿瘤和癌前病变历史数据数据库按照高度标准化的程序收集数据，包括组织采样和修整、根据国际统一命名法和诊断标准进行的组织病理学检查以及同行评审。所有录入的病变均根据国际癌症研究机构（IARC）/世界卫生组织（WHO）的标准进行一致诊断。数据的有效性还通过数据库病理学家进行的全面同行评审得到进一步确认。模棱两可的诊断和选定的病例会另外提交给RITA病理学家小组。在RITA数据库中，目前有来自106项研究的10,896只大鼠，有超过17,604个原发性肿瘤和16,551个癌前病变。本文简要描述了Wistar大鼠、Sprague Dawley大鼠以及不同小鼠品系的历史对照数据的RITA数据库。基于RITA背景数据，Wistar大鼠的存活率在10年期间一直保持稳定。患瘤动物的出现率在十年间也呈现出稳定的百分比。此外，还给出了历史对照数据在罕见肿瘤或肿瘤及癌前病变发生率略有增加的情况下如何支持致癌风险评估的示例。
