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中华乳腺病杂志(电子版) ›› 2021, Vol. 15 ›› Issue (05) : 263 -274. doi: 10.3877/cma.j.issn.1674-0807.2021.05.001

所属专题: 指南共识

指南与共识

浙江省早期乳腺癌辅助治疗多基因检测应用专家共识(2020版)
浙江省早期乳腺癌辅助治疗多基因检测应用共识专家组   
  • 收稿日期:2020-10-11 出版日期:2021-10-01
  • 基金资助:
    浙江省自然科学基金资助项目(LY18H160033); 浙江省医药卫生科研基金资助项目(2020KY491)

Expert consensus on multigene assay in adjuvant treatment of early breast cancer in Zhejiang Province(version 2020)

Expert panel for multigene assay consensus in adjuvant treatment of early breast cancer in Zhejiang Province   

  • Received:2020-10-11 Published:2021-10-01
引用本文:

浙江省早期乳腺癌辅助治疗多基因检测应用共识专家组. 浙江省早期乳腺癌辅助治疗多基因检测应用专家共识(2020版)[J]. 中华乳腺病杂志(电子版), 2021, 15(05): 263-274.

Expert panel for multigene assay consensus in adjuvant treatment of early breast cancer in Zhejiang Province. Expert consensus on multigene assay in adjuvant treatment of early breast cancer in Zhejiang Province(version 2020)[J]. Chinese Journal of Breast Disease(Electronic Edition), 2021, 15(05): 263-274.

表1 乳腺癌辅助治疗多基因检测工具
商品名 基因数(个) 检测平台与方法 样本类型 检测结果分类 临床适应证 前瞻性验证临床试验 机构认证 原始验证数据集 推荐的指南/科学协会
Oncotype Dx(21基因) 21 RT-PCR 石蜡组织 高风险/中风险/低风险 ER阳性、HER-2阴性、腋窝淋巴结阴性或者1~3枚阳性早期乳腺癌患者的预后预测以及化疗决策指导 TAILORx[15,16](N0期,阳性结果)/RxPONDER[19](N1期,阳性结果) EMA,FDA 在NSABP B-20和B-14研究中仅接受他莫昔芬治疗的乳腺癌患者 ASCO、EGTM、ESMO、NCCN、St. Gallen Consensus
Mammaprint(70基因) 70 DNA-Microarray/ NGS 冰冻组织/石蜡组织 高风险/低风险+分子分型 ER阳性、HER-2阴性、腋窝淋巴结阴性或者1~3枚阳性早期乳腺癌患者的预后预测以及化疗决策指导 MINDACT[25,26,27,28](阳性结果) EMA,FDA 年轻乳腺癌患者(<55岁),术后未接受全身治疗 ASCO、EGTM、ESMO、NCCN、St. Gallen Consensus
RecurIndex(28基因) 28 RT-PCR 石蜡组织 高风险/低风险 ER阳性、HER-2阴性、腋窝淋巴结阴性或者1~3枚阳性早期乳腺癌患者的预后预测,化疗决策指导以及放疗决策指导 RIGAIN(开展中) 未批准 不同分期、不同分子分型的亚洲乳腺癌患者 /
Prosigna(PAM50) 50 Nanostring 石蜡组织 高风险/中风险/低风险+分子分型 ER阳性、HER-2阴性、腋窝淋巴结阴性或者1~3枚阳性早期乳腺癌患者的预后预测以及化疗决策指导 OPTIMA (开展中) EMA,FDA 绝经后乳腺癌患者 ASCO、EGTM、ESMO、St. Gallen Consensus
Endopredict 11 RT-PCR 石蜡组织 高风险/低风险 ER阳性、HER-2阴性、腋窝淋巴结阴性或者1~3枚阳性早期乳腺癌患者的预后预测以及化疗决策指导 EMA,FDA 在ABCSG-6、8试验中仅接受内分泌治疗的绝经后乳腺癌患者 ASCO、EGTM、ESMO、St. Gallen Consensus
Breast Cancer Index 7 RT-PCR 石蜡组织 高风险/低风险/+高收益/低收益 ER阳性、HER-2阴性、腋窝淋巴结阴性早期乳腺癌患者的预后预测以及化疗决策指导 未批准 仅用他莫昔芬治疗的乳腺癌患者 ASCO、EGTM、St. Gallen Consensus
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