Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update.
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update.
复制标题
DOI：
10.1200/jco.2017.74.0472
复制
发表时间：
2017-08-20
期刊：
影响因子：
--
通讯作者：
Stearns V
中科院分区：
文献类型：
--
作者：
Krop I;Ismaila N;Andre F;Bast RC;Barlow W;Collyar DE;Hammond ME;Kuderer NM;Liu MC;Mennel RG;Van Poznak C;Wolff AC;Stearns V
这一重点更新涉及使用MammaPrint （Agendia, Irvine， CA）来指导使用辅助全身治疗的决策。ASCO使用信号方法促进指南更新。对于这一重点更新，发表的III期随机化MINDACT（微阵列在淋巴结阴性和1至3阳性淋巴结疾病中可能避免化疗）研究提供了一个信号，该研究评估了6693名早期乳腺癌女性的MammaPrint检测。一个专家小组审查了MINDACT研究的结果以及其他关于MammaPrint检测的已发表文献，以评估临床应用的证据。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，由于能够识别预后良好但化疗获益有限的人群，因此，MammaPrint检测可用于临床高风险的患者，以告知是否拒绝辅助全身化疗的决定。低临床风险类别的女性没有从化疗中获益，无论基因组mamaprint风险组如何。因此，MammaPrint检测在这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，则MammaPrint检测可用于1至3个阳性淋巴结和高临床风险的患者，以决定是否放弃辅助全身化疗。然而，这些患者应该被告知，化疗的益处不能被排除，特别是对于有一个以上淋巴结受援的患者。对于低临床风险的激素受体阳性、her2阴性、淋巴结阳性乳腺癌患者，以及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策，因为在这些人群中缺乏明确的数据。更多信息可在www.asco.org/breast-cancer-guidelines和www.asco.org/guidelineswiki找到。
This focused update addresses the use of MammaPrint (Agendia, Irvine, CA) to guide decisions on the use of adjuvant systemic therapy. 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. 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.