PDF(Pubmed)
Abstract：
To date, the definition that the off-label usage of drugs refers to the unapproved use of approved drugs, which covers unapproved indications, patient populations, doses, and/or routes of administration, has been in existence for many years. Currently, there is a limited frequency and prevalence of research on the off-label use of antineoplastic drugs, mainly due to incomplete definition and classification issues. It is time to embrace new categories for the off-label usage of anticancer drugs. This review provided an insight into an updated overview of the concept and categories of the off-label use of anticancer drugs, along with illustrating specific examples to establish the next studies about the extent of the off-label usage of anticancer drugs in the oncology setting. The scope of the off-label use of current anticancer drugs beyond the previous definitions not only includes off-label uses in terms of indications, patient populations, doses, and/or routes of administration but also off-label use in terms of medication course, combination, sequence of medication, clinical purpose, contraindications scenarios, etc. In addition, the definition of the off-label usage of anticancer drugs should be added to the condition at a given time, and it varies from approval authorities. We presented a new and relatively comprehensive classification, providing extensive analysis and illustrative examples of the off-label usage of antineoplastic drugs for the first time. Such a classification has the potential to promote practical adoption and enhance management strategies for the off-label use of antitumor drugs.
摘要：
迄今为止,药品的非说明书使用是指未经批准使用已批准的药品，涵盖未经批准的适应症，患者群体，剂量,和/或给药途径，已经存在很多年了。目前,关于抗肿瘤药物的标签外使用的研究频率和普遍性有限，主要是由于定义和分类问题不完整。现在是时候接受抗癌药物标签外使用的新类别了。这篇综述提供了对抗癌药物标签外使用的概念和类别的最新概述，以及举例说明具体的例子，以建立关于抗癌药物在肿瘤学环境中的标签外使用程度的下一步研究。目前的抗癌药物超出以前定义的标签外使用范围不仅包括适应症方面的标签外使用，患者群体，剂量,和/或给药途径，以及药物疗程方面的标签外使用，组合,药物的顺序，临床目的,禁忌症场景，等。此外,抗癌药的标签外用法的定义应在给定时间添加到该病症中，它不同于审批机构。我们提出了一个新的和相对全面的分类，首次提供抗肿瘤药物标签外使用的广泛分析和说明性示例。这种分类有可能促进实际采用并增强抗肿瘤药物的标签外使用的管理策略。
