| 标题： | 靶向HER-2的抗体偶联药物超说明书用药专家共识 |
| title： | Expert consensus on off-label use of HER-2 antibody-drug conjugate |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 专家共识 |
| classification： | Experts consensus |
| 领域： | 管理 |
| field： | Administration |
| 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、药师和其他相关领域） |
| Guide users： | Clinical physicians at all levels (including doctor, pharmacist and other relevant fields) |
| 证据分级方法： | 对于指南和共识证据，证据类别和推荐等级使用原指南采用的分级标准，未标注证据类别和推荐等级的指南以及临床试验证据按CSCO证据分级标准进行评价。 |
| Evidence grading method： | For guidelines and consensus evidence, the evidence category and recommendation level use the grading standards adopted by the original guidelines. Guidelines without marked evidence category and recommendation level and clinical trials are evaluated according to the CSCO evidence grading standards. |
| 制定单位： | 浙江省肿瘤医院 |
| Formulating unit： | Zhejiang Cancer Hospital |
| 注册时间： | 2024-10-14 |
| Registration time： | |
| 注册编号： | PREPARE-2024CN814 |
| Registration number： | |
| 指南制订的目的： | 近年来，抗体偶联药物（Antibody-drug conjugate, ADC）逐渐成为肿瘤精准治疗领域的热门研究方向之一。目前上市的ADC药物中，HER-2为探索最多的靶点。然而，抗HER-2 ADC药物超说明书用药现象普遍存在。本共识基于国内外药品说明书、指南与专家共识、已发表的文献证据，对抗HER-2 ADC药物超说明书用法进行系统梳理和循证评价，并由共识专家组形成抗HER-2 ADC药物超说明书用药的推荐意见，为抗HER-2 ADC药物的临床合理用药提供依据。 |
| Purpose of the guideline： | In recent years, antibody-drug conjugates (ADC) have gradually become one of the hottest research fields related to cancer treatment. Among the approved ADCs, HER-2 is the most explored target. However, the off-label use of anti-HER-2 ADC is common. Based on drug labels, guidelines, expert consensus and published literature evidence, this consensus systematically sorts out and conducts evidence-based evaluation of the off-label use of anti-HER-2 ADC. And the consensus expert group forms recommendations for the off-label use of anti-HER-2 ADC in order to providing reference for the clinical rational use of anti-HER-2 ADC. |
