Maluish A E, Herberman R B
Cancer Treat Rep. 1985 Oct;69(10):1165-9.
During the past several years, increasing attention has been devoted to the use of biological response modifiers (BRMs) for the treatment of cancer. Phase I trials of BRMs must be designed to provide information not only regarding toxic effects, pharmacokinetics, and antitumor activities, but also on the many immunomodulatory effects. Biological monitoring must be carefully planned to enable meaningful conclusions to be drawn as to the optimal dose, schedule, and route of administration. Important considerations include selection of assays for the various biological effects, timing of testing following BRM administration, and methods for data interpretations.
在过去几年中，人们越来越关注使用生物反应调节剂（BRM）来治疗癌症。BRM的I期试验设计不仅要提供有关毒性作用、药代动力学和抗肿瘤活性的信息，还要提供有关许多免疫调节作用的信息。必须精心规划生物监测，以便能够就最佳剂量、给药方案和给药途径得出有意义的结论。重要的考虑因素包括选择针对各种生物学效应的检测方法、BRM给药后进行检测的时间以及数据解释方法。
