早期乳腺癌多基因检测临床实践指南2021.V1(CSBrS-Guideline-07)

标题: 早期乳腺癌多基因检测临床实践指南2021.V1(CSBrS-Guideline-07)
title: Clinical Practice Guidelines for Multigene Assays in Patients with Early-Stage Breast Cancer: Chinese Society of Breast Surgery (CSBrS) Practice Guidelines 2021
版本: 原创版
version: Original
分类: 标准指南
classification: Standard guideline
领域: 治疗
field: Treatment
国家和地区: 中国
Country and region: China
指南使用者: 中国乳腺疾病专业临床医生
Guide users: Clinicians specializing in breast diseases in China
证据分级方法: The level of evidence grading system was developed by referring to the GRADE system combined with findings in clinical studies in China. The levels are classified as Category I, II, III, and IV to quantify the evaluation of the reliability of the evidence by experts on the compiling committees. To make these guidelines accessible in clinical practice in China, the expert panel preferentially selected Category I and II evidence, as indicated in the guideline evaluation system . I Based on high-level prospective randomized controlled clinical trials, observational studies or meta-analyses with large sample sizes, internationally-recognized current guidelines and consensus statements, published guidelines and consensus statements from national societies or associations, Chinese population-based studies of the above types published in SCI journals, MEDLINE journals, and Chinese series journals II Based on low-level randomized clinical trials, well-designed non-controlled trials or cohort studies, inter-continental professional association guidelines and international conference expert consensus statements, published guidelines and consensus statements from national regional societies or associations, Chinese population-based studies of the above types published in PKU core journals III Based on case-control studies or retrospective studies, published guidelines and consensus statements from national professional associations, and provincial societies or associations, Chinese population-based studies of the above types published in source journals for Chinese scientific and technical papers and citations IV Based on case reports, scientific hypotheses, regional expert consensus statements and published guidelines and consensus statements from national local societies or associations, Chinese population-based studies of the above types published in non-aforementioned core journals
Evidence grading method:
制定单位: 中华医学会外科学分会乳腺外科学组
Formulating unit: Chinese Society of Breast Surgery (CSBrS)
注册时间: 2021-06-07
Registration time:
注册编号: IPGRP-2021CN154
Registration number:
指南制订的目的: 多基因检测(Multigene profiling assays)在早期浸润性乳腺癌患者制定辅助化疗决策中的地位已经获得广泛共识。2017 年 7 月美国临床肿瘤学会(American Society of Clinical Oncology,ASCO)多基因检测临床指南重点提高了MammaPrint®临床应用的推荐强度。2018年1月正式使用的美国癌症联合委员会(American Joint Committee on Cancer,AJCC)第8版癌症分期系统首次建立了预后分期的理念,增加非解剖学信息对预后进行评价,首次以Ⅰ类证据推荐适应证人群选择Oncotype Dx®多基因检测,并正式纳入Oncotype Dx®、 MammaPrint®、EndoPredict®、PAM 50® 以及 Breast Cancer Index(BCI)5种检测技术。为提高乳腺肿瘤专业医生合理选择多基因检测适应证人群及检测方法、谨慎参考多基因检测结果制定辅助治疗决策,中华医学会外科学分会乳腺外科学组通过文献调研与专家讨论,提出多基因检测临床实践指南的关键临床问题,参照GRADE(Grading of Recommendations Assessment, Development and Evaluation)系统对相关证据进行评价,并结合中国临床可及性,制定出版中华医学会外科学分会乳腺外科学组(CSBrS)早期乳腺癌多基因检测临床实践指南(2021版)。旨在为中国乳腺疾病专业临床医生提供借鉴参考。
Purpose of the guideline: The role of multigene assays in chemotherapy decision-making in patients with early invasive breast cancer has been widely recognized. In 2017, the American Society of Clinical Oncology (ASCO) clinical guidelines for multigene profiling assays focused on increasing the intensity of recommendations for the clinical use of MammaPrint®. The 8th edition of the American Joint Committee on Cancer (AJCC) staging system, officially launched in 2018, established the concept of prognostic staging for the first time, adding the use of non-anatomical information to evaluate the prognosis. Initially, Oncotype Dx® was recommended for suitable patients based on Level I evidence. Subsequently, five testing techniques, Oncotype Dx®, MammaPrint®, EndoPredict®, PAM50®, and BCI, were formally incorporated into the system. To assist breast disease specialists in China in their selection of appropriate multigene profiling assays and detection methods for patients, and also to instill caution on decision-making with reference to multigene assays, the Chinese Society of Breast Surgery (CSBrS) has, through literature investigation and expert discussion, provided information on the key clinical problems and guidelines for the use of multigene assays, evaluating the evidence with reference to the Grades of Recommendations Assessment Development and Evaluation (GRADE) system. Combined with the availability of these assays in China, the clinical practice guidelines for multigene assays were formulated and published. The purpose of this guideline is to provide a reference for clinicians specializing in breast diseases in China.