乳腺癌内分泌用药超说明书用药专家共识

标题: 乳腺癌内分泌用药超说明书用药专家共识
title: Expert consensus on off-label use of endocrine therapy in the treatment of breast cancer
版本: 原创版
version: Original
分类: 专家共识
classification: Experts consensus
领域: 诊疗
field: Diagnosis and Treatment
国家和地区: 中国
Country and region: China
指南使用者: 各级临床人员(包括医师、药学和其他领域)
Guide users: Clinical physicians at all levels (including doctor, pharmacist and other relevant fields)
证据分级方法: CSCO分级系统
Evidence grading method: CSCO grading system
制定单位: 中国临床肿瘤学会乳腺癌专家委员会
Formulating unit: Chinese Society of Clinical Oncology Breast Cancer
注册时间: 2023-04-05
Registration time:
注册编号: PREPARE-2023CN242
Registration number:
指南制订的目的: 内分泌治疗作为乳腺癌治疗的重要手段之一,随着一些新型内分泌治疗药物的上市,以及临床研究数据的不断更新,并且涉及到药物的可及性等问题,乳腺癌内分泌治疗药品说明书所批准的适应证、适用人群、用法用量、给药途径等不足以满足乳腺癌内分泌治疗真实世界的治疗需求,超说明书用法客观存在,其使用的规范性待完善。本共识旨在基于国内外药品说明书注册内容、指南共识、临床研究等循证医学证据内容,对乳腺癌内分泌治疗中的超说明书用法进行循证评价,然后由专家组形成乳腺癌内分泌治疗超药品说明书用药的推荐意见,为临床医生提供合理用药依据,进一步规范乳腺癌内分泌治疗的超药品说明书用药的临床应用。
Purpose of the guideline: Endocrine therapy is one of the important means of breast cancer treatment. With the launch of some new endocrine therapy drugs and the continuous updating of clinical research data, as well as issues related to the accessibility of drugs, the approved indications, applicable groups, dosage and route of administration of breast cancer endocrine therapy drugs are not sufficient to meet the real-world treatment needs of breast cancer endocrine therapy. Off-label drug use is an objective clinical practice. The aim of this consensus is to make an evidence-based evaluation of the use of over-specified drugs in breast cancer endocrine therapy based on the content of domestic and foreign drug registration, consensus guidelines, clinical studies and other evidence-based medical evidence, and then for the expert group to form a recommendation on the use of over-specified drugs in breast cancer endocrine therapy, so as to provide clinicians with a rational basis for the use of drugs and further regulate the off-label drug use in breast cancer endocrine therapy. The expert group will then form recommendations, providing clinicians with a rational basis for their use and further standardizing the clinical application of off-label drug use in breast cancer.