21基因检测在早期乳腺癌辅助放疗中的应用

doi:10.16139/j.1007-9610.2024.03.15

摘要/Abstract

摘要：

乳腺癌是女性发病率最高的恶性肿瘤。随着基因组学技术和医学前沿技术的发展，乳腺癌的全身治疗逐渐进入个体化医疗时代。但是乳腺癌的辅助放疗决策仍然主要依赖于临床病理因素，缺乏科学可靠的工具来指导不同人群的精准放疗。激素受体（HR）阳性/人表皮生长因子受体2（HER2）阴性型乳腺癌是乳腺癌最常见的分子亚型，21基因复发评分（RS）（Oncotype Dx™, Genomic Health, Redwood City, CA）是一种商业可用的乳腺癌基因组测试。本文回顾了目前关于21基因RS用于HR阳性HER2阴性早期乳腺癌放疗决策的研究证据。目前的临床研究支持21基因RS对辅助放疗疗效具有预测价值，该领域几项大规模的前瞻性临床研究正在进行中。

关键词: 乳腺癌, 放射治疗, 21基因复发评分

Abstract:

Breast cancer is the most common malignant tumor in women. With the development of genomics technology and medical frontier technology, the systemic treatment of breast cancer has gradually entered the era of personalized medicine. However, the decision-making of adjuvant radiotherapy for breast cancer still mainly relies on traditional clinicopathological factors, and there is a lack of scientific and reliable tools to guide precise radiotherapy in different populations. Hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer is the most common molecular subtype of breast cancer. The 21-Gene recurrence score (RS) test (Oncotype Dx™, Genomic Health, Redwood City, CA) is a commercially available genomic test for breast cancer. In this article, we reviewed the current research evidence on the use of 21-Gene RS test for radiotherapy decision-making in HR-positive HER2-negative early breast cancer. Current clinical studies support the predictive value of 21-Gene RS test for adjuvant radiotherapy, and several large-scale prospective clinical studies in this area are underway.

Key words: Breast cancer, Radiotherapy, 21-Gene recurrence score

中图分类号:

R737.9
R815

唐筱璐, 华鑫, 曹璐, 陈佳艺. 21基因检测在早期乳腺癌辅助放疗中的应用[J]. 外科理论与实践, 2024, 29(03): 270-276.

TANG Xiaolu, HUA Xin, CAO Lu, CHEN Jiayi. Application of 21-Gene test in adjuvant radiotherapy for early breast cancer[J]. Journal of Surgery Concepts & Practice, 2024, 29(03): 270-276.

图/表 1

参考文献 56

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Item	IDEA	TAILOR RT	DEBRA
Study type	Interventional	Interventional	Interventional
Estimated enrollment	202	2 140	1 670
Allocation	N/A	Randomized	Randomized
Intercention model	Single group assignment	Parallel assignment	Parallel assignment
Masking	Open label	Open label	Open label
Ages eligible for study(Years)	50-69	≥35	50-70
TNM stage	pT1N0M0	pT1-2N1 or pT3N0	pT1N0
Surgery	BCS^a)	BCS or Mastectomy	Lumpectomy
Recurrence score	≤18	≤25	≤18
Arm	-ET^b)	-no RT^c) -RT	-ET⁺RT -ET
Primary outcomes	LRR^d)	BCRFI^e)	invasive or non-invasive IBTR^f)
Actual study start date	2015.03	2018.05	2021.06
Estimated primary completion date	2026.03	2027.09	2026.01
Estimated study completion date	2026.03	2027.12	2041.07