Purpose This focused update addresses the use of MammaPrint (Agendia, Irvine, CA) to guide decisions on the use of adjuvant systemic therapy. Methods ASCO uses a signals approach to facilitate guideline updates. For this focused update, the publication of the phase III randomized MINDACT (Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy) study to evaluate the MammaPrint assay in 6,693 women with early-stage breast cancer provided a signal. An expert panel reviewed the results of the MINDACT study along with other published literature on the MammaPrint assay to assess for evidence of clinical utility. Recommendations If a patient has hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-negative breast cancer, the MammaPrint assay may be used in those with high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy due to its ability to identify a good-prognosis population with potentially limited chemotherapy benefit. Women in the low clinical risk category did not benefit from chemotherapy regardless of genomic MammaPrint risk group. Therefore, the MammaPrint assay does not have clinical utility in such patients. If a patient has hormone receptor-positive, HER2-negative, node-positive breast cancer, the MammaPrint assay may be used in patients with one to three positive nodes and a high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy. However, such patients should be informed that a benefit from chemotherapy cannot be excluded, particularly in patients with greater than one involved lymph node. The clinician should not use the MammaPrint assay to guide decisions on adjuvant systemic therapy in patients with hormone receptor-positive, HER2-negative, node-positive breast cancer at low clinical risk, nor any patient with HER2-positive or triple-negative breast cancer, because of the lack of definitive data in these populations. Additional information can be found at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki .

中文翻译：

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使用生物标志物指导早期浸润性乳腺癌女性辅助全身治疗的决定：美国临床肿瘤学会临床实践指南重点更新

目的 本次重点更新解决了使用 MammaPrint（Agendia，Irvine，CA）指导辅助全身治疗使用决策的问题。方法 ASCO 使用信号方法来促进指南更新。对于这一重点更新，发表的 III 期随机 MINDACT（淋巴结阴性和 1 至 3 阳性淋巴结病可避免化疗的微阵列）研究在 6,693 名早期乳腺癌女性中评估 MammaPrint 检测提供了一个信号。一个专家小组审查了 MINDACT 研究的结果以及关于 MammaPrint 检测的其他已发表文献，以评估临床效用的证据。建议 如果患者患有激素受体阳性、人表皮生长因子受体 2 (HER2) 阴性、淋巴结阴性的乳腺癌，MammaPrint 检测可用于具有高临床风险的患者，因为它能够识别具有潜在有限化疗益处的良好预后人群，从而为停止辅助全身化疗的决定提供信息。无论基因组 MammaPrint 风险组如何，低临床风险类别的女性都没有从化疗中受益。因此，MammaPrint 检测在此类患者中没有临床效用。如果患者患有激素受体阳性、HER2 阴性、淋巴结阳性的乳腺癌，MammaPrint 检测可用于具有 1 到 3 个阳性淋巴结且临床风险较高的患者，以告知关于停止辅助全身化疗的决定。然而，应告知此类患者不能排除化疗的益处，尤其是在淋巴结受累超过一个的患者中。对于临床风险较低的激素受体阳性、HER2 阴性、淋巴结阳性乳腺癌患者，以及任何 HER2 阳性或三阴性乳腺癌患者，临床医生不应使用 MammaPrint 检测来指导辅助全身治疗的决定，因为在这些人群中缺乏明确的数据。更多信息可以在 www.asco.org/breast-cancer-guidelines 和 www.asco.org/guidelineswiki 上找到。