共识与指南
ENGLISH ABSTRACT
非小细胞肺癌分子病理检测临床实践指南(2024版)
国家病理质控中心
中华医学会病理学分会
中华医学会肿瘤学分会肺癌学组
中国抗癌协会肺癌专业委员会
中国胸部肿瘤研究协助组
作者及单位信息
·
DOI: 10.3760/cma.j.cn112151-20240527-00338
Guidelines on clinical practice of molecular tests in non-small cell lung cancer in China (2024 version)
Pathology Quality Control Center
Chinese Society of Pathology
Chinese Medical Association Chinese Society of Oncology
China Anti-Cancer Association Chinese Society of Lung Cancer
Chinese Thoracic Oncology Group
Liang Zhiyong
Wu Yilong
Lu Shun
Authors Info & Affiliations
Pathology Quality Control Center
Chinese Society of Pathology
Chinese Medical Association Chinese Society of Oncology
China Anti-Cancer Association Chinese Society of Lung Cancer
Chinese Thoracic Oncology Group
Liang Zhiyong
Department of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing 100730, China
Wu Yilong
Department of Oncology, Guangdong Provincial People′s Hospital and Guangdong Academy of Medical Sciences, Guangdong Lung Cancer Institute, Guangzhou 510080, China
Lu Shun
Department of Oncology, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 200030, China
·
DOI: 10.3760/cma.j.cn112151-20240527-00338
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摘要

非小细胞肺癌(non-small cell lung cancer,NSCLC)精准治疗显著提高了患者疗效,包括靶向治疗及免疫治疗,其前提是精准的分子分型。选择准确、快速、恰当的检测方法,全面筛选出适用靶向和免疫药物的目标人群具有重要临床意义。随着临床对分子病理检测内涵需求的不断增加,尤其是我国临床实践数据的不断积累、新型治疗药物及适用人群的扩展,亟待对NSCLC分子病理检测的实践指导内容进行更新。本指南在原有内容的基础上更新了分子病理检测人群的范围,增加了表皮生长因子受体(EGFR)外显子20插入突变作为靶向治疗必检位点,增加了RET、BRAF及NTRK基因变异作为必检基因变异,优化了检测策略。同时,本指南更加注重依据循证医学证据,对推荐意见证据质量级别及推荐意见级别进行了分级,以供使用者参考。本指南为全面准确的NSCLC分子病理检测提供指导。

引用本文

国家病理质控中心,中华医学会病理学分会,中华医学会肿瘤学分会肺癌学组,等. 非小细胞肺癌分子病理检测临床实践指南(2024版)[J]. 中华病理学杂志,2024,53(10):981-995.

DOI:10.3760/cma.j.cn112151-20240527-00338

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靶向治疗及免疫治疗在非小细胞肺癌(non-small cell lung cancer,NSCLC)的治疗中发挥了重要的作用,分子分型是NSCLC实施治疗的前提。检测的标准化可提升检测结果的准确性,使患者更大程度上获益。自《非小细胞肺癌分子病理检测临床实践指南(2021版)》制定发布以来 1,对如何选择检测人群、检测标本与检测方法,以及制定、优化规范化检测流程起到了指导作用。随着临床对分子病理检测内涵需求的不断增加,尤其是我国临床实践数据的不断积累、新型治疗药物及适用人群的扩展,亟待对NSCLC分子病理检测的实践指导内容进行更新。
本指南一贯基于国内临床实践数据及结合中国国情,以国内已上市治疗药物及体外诊断检测试剂为导向制定,重在对分子病理检测实践的指导。2024版指南在2021版指南框架的基础上,更加着重基于循证医学证据,针对临床病理问题进行全面文献检索后,对证据质量进行分级,同时由专家委员会委员针对推荐意见进行推荐级别投票。指南更新内容包括分子病理检测人群的更新,增加了表皮生长因子受体(EGFR)外显子20插入突变作为必检位点,增加了RET、BRAF及NTRK基因变异作为必检基因变异,优化了检测策略,具体内容见下文。
本指南由国家病理质控中心、中华医学会病理学分会、中华医学会肿瘤学分会肺癌学组、中国抗癌协会肺癌专业委员会、中国胸部肿瘤研究协作组牵头。本指南成立了多学科工作组,涵盖病理科、呼吸内科、胸外科、肿瘤内科等多个学科的专家。根据职责分为指南指导委员会、执笔人、专家共识组和证据评价组。所有工作组成员填写了利益声明表,均不存在与本指南直接的利益冲突。
通过系统检索国内外NSCLC分子病理检测领域已发表的指南和系统评价,工作组初步拟定了8大类关键问题框架,涵盖40个临床问题,以在线问卷的形式对临床问题的重要性进行调研和评分。最终遴选出本指南拟解决的38个临床问题。
指南证据检索及评价小组,针对最终纳入的关键临床问题,按照人群(临床问题)、干预(测试指标)、对照(参考指标)和结局原则进行检索,具体检索数据库包括PubMed、Embase.com、Clinicaltrial.gov、Cochrane Library、Web of Science、中国知网、万方数据知识服务平台、维普资讯网和中国生物医学文献数据库。对检索到的相关文献进行归纳整理及数据提取,使用推荐意见分级的评估、制定及评价(Grading of Recommendations Assessment Development and Evaluation,GRADE)方法对证据质量进行分级 2。指南制定工作组基于证据检索与评价小组提供的国内外证据,同时考虑我国筛查目标人群的偏好和价值观、筛查措施的成本和利弊后,初步拟定了临床问题推荐意见。以德尔菲法通过邮件形式发送至相关专家进行意见征询,在对推荐意见进行了进一步修改后并达成推荐意见推荐强度共识。GRADE证据质量及推荐强度分级标准参见 表1
项目 内容
证据质量分级
非常有把握,观察值接近真实值
对观察值有中等把握:观察值有可能接近真实值,但亦有可能差别很大
对观察值的把握有限:观察值可能与真实值有较大差别
极低 对观察值几乎无把握:观察值与真实值可能有极大差别
推荐强度分级
明确显示干预措施利大于弊或弊大于利
利弊不确定或无论质量高低的证据均显示利弊相当
分级的评估、制定及评价证据质量及推荐强度分级
本指南已在国际实践指南注册与透明化平台完成注册,注册网址: http://www.guidelines-registry.cn/,注册号:PREPARE-2022CN786。
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备注信息
A
梁智勇(中国医学科学院 北京协和医学院 北京协和医院病理科,北京100730),Email: nc.defhcabmupyzgnail
B
吴一龙(广东省人民医院肿瘤内科 广东省肺癌研究所,广州 510080),Email: nc.defevabiluwlyys
C
陆舜(上海市胸科医院 上海交通大学附属胸科医院肿瘤科,上海 200030),Email: nc.defudabe.utjsulnuhs
D

执笔人:师晓华(中国医学科学院 北京协和医学院 北京协和医院病理科,北京 100730);应建明(国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院 北京协和医学院 肿瘤医院病理科,北京 100021)

E
国家病理质控中心 中华医学会病理学分会 中华医学会肿瘤学分会肺癌学组 中国抗癌协会肺癌专业委员会 中国胸部肿瘤研究协助组. 非小细胞肺癌分子病理检测临床实践指南(2024版)[J]. 中华病理学杂志, 2024, 53(10): 981-995. DOI: 10.3760/cma.j.cn112151-20240527-00338.
F
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