摘要
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®.[1]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.[2]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.