University of Michigan, Ann Arbor, MI.
American Society of Clinical Oncology, Alexandria, VA.
J Clin Oncol. 2022 Sep 20;40(27):3205-3221. doi: 10.1200/JCO.22.01063. Epub 2022 Jun 27.
To update the ASCO Biomarkers to Guide Systemic Therapy for Metastatic Breast Cancer (MBC) guideline.
An Expert Panel conducted a systematic review to identify randomized clinical trials and prospective-retrospective studies from January 2015 to January 2022.
The search identified 19 studies informing the evidence base.
Candidates for a regimen with a phosphatidylinositol 3-kinase inhibitor and hormonal therapy should undergo testing for mutations using next-generation sequencing of tumor tissue or circulating tumor DNA (ctDNA) in plasma to determine eligibility for alpelisib plus fulvestrant. If no mutation is found in ctDNA, testing in tumor tissue, if available, should be used. Patients who are candidates for poly (ADP-ribose) polymerase (PARP) inhibitor therapy should undergo testing for germline and pathogenic or likely pathogenic mutations to determine eligibility for a PARP inhibitor. There is insufficient evidence for or against testing for a germline pathogenic variant to determine eligibility for PARP inhibitor therapy in the metastatic setting. Candidates for immune checkpoint inhibitor therapy should undergo testing for expression of programmed cell death ligand-1 in the tumor and immune cells to determine eligibility for treatment with pembrolizumab plus chemotherapy. Candidates for an immune checkpoint inhibitor should also undergo testing for deficient mismatch repair/microsatellite instability-high to determine eligibility for dostarlimab-gxly or pembrolizumab, as well as testing for tumor mutational burden. Clinicians may test for fusions to determine eligibility for TRK inhibitors. There are insufficient data to recommend routine testing of tumors for mutations, for homologous recombination deficiency, or for TROP2 expression to guide MBC therapy selection. There are insufficient data to recommend routine use of ctDNA or circulating tumor cells to monitor response to therapy among patients with MBC.Additional information can be found at www.asco.org/breast-cancer-guidelines.
更新 ASCO 生物标志物指导转移性乳腺癌（MBC）系统治疗指南。
专家组进行了系统评价，以确定 2015 年 1 月至 2022 年 1 月期间的随机临床试验和前瞻性回顾性研究。
搜索确定了 19 项研究为证据基础提供信息。
接受含磷脂酰肌醇 3-激酶抑制剂和激素治疗方案的患者应进行肿瘤组织或血浆中循环肿瘤 DNA（ctDNA）的下一代测序，以检测 突变，确定是否有资格接受 alpelisib 联合氟维司群治疗。如果在 ctDNA 中未发现突变，则应使用肿瘤组织进行检测，如果有肿瘤组织的话。有资格接受聚（ADP-核糖）聚合酶（PARP）抑制剂治疗的患者应进行种系 和 致病性或可能致病性突变检测，以确定是否有资格接受 PARP 抑制剂治疗。在转移性环境中，尚无足够的证据支持或反对检测种系 致病性变体以确定是否有资格接受 PARP 抑制剂治疗。有资格接受免疫检查点抑制剂治疗的患者应进行肿瘤和免疫细胞中程序性细胞死亡配体-1 的表达检测，以确定是否有资格接受 pembrolizumab 联合化疗治疗。有资格接受免疫检查点抑制剂治疗的患者还应进行错配修复缺陷/微卫星不稳定高检测，以确定是否有资格接受 dostarlimab-gxly 或 pembrolizumab 治疗，以及进行肿瘤突变负担检测。临床医生可能会检测 融合以确定是否有资格接受 TRK 抑制剂治疗。尚无足够数据推荐常规检测肿瘤的 突变、同源重组缺陷或 TROP2 表达，以指导 MBC 治疗选择。尚无足够数据推荐常规使用 ctDNA 或循环肿瘤细胞来监测 MBC 患者的治疗反应。更多信息可在 www.asco.org/breast-cancer-guidelines 上找到。
