Clinical Practice Guidelines for Multigene Assays in Patients with Early-Stage Breast Cancer: Chinese Society of Breast Surgery (CSBrS) Practice Guidelines 2021

Title: Clinical Practice Guidelines for Multigene Assays in Patients with Early-Stage Breast Cancer: Chinese Society of Breast Surgery (CSBrS) Practice Guidelines 2021
Edition: Original
Classification: Standard guideline
Field: Treatment
Countries and regions: China
Guidelines users: Clinicians specializing in breast diseases in China
Evidence classification method: 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
Development unit: 中华医学会外科学分会乳腺外科学组
Registration time: 2021-06-07
Registration number: IPGRP-2021CN154
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.