Retrospective study on regional lymph node radiotherapy after axillary dissection exemption in breast cancer patients with sentinel lymph node positive status

Yongjin LU; Zhiqiang SHI; Tong LI; Yongsheng WANG; Pengfei QIU

doi:10.19401/j.cnki.1007-3639.2025.02.010

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Retrospective study on regional lymph node radiotherapy after axillary dissection exemption in breast cancer patients with sentinel lymph node positive status

Specialist's Article | 更新时间：2025-12-31

- Retrospective study on regional lymph node radiotherapy after axillary dissection exemption in breast cancer patients with sentinel lymph node positive status
- China Oncology Vol. 35, Issue 2, Pages: 228-236(2025)
- 作者机构：
  
  1. 山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院山东省肿瘤医院），山东济南 250117
  2. 山东第一医科大学（山东省医学科学院），山东济南 250117
  3. 济南市第四人民医院，山东第一医科大学第三附属医院，山东济南 250031
- 作者简介：
- 基金信息：
  
  National Natural Science Foundation of China(82172873);International (Regional) Cooperation and Exchange Project(W2421095);Shandong Province Taishan Scholars Program of(tsqn202211337);Jinan Science and Technology Plan(202430063)
- DOI：10.19401/j.cnki.1007-3639.2025.02.010
  CLC： R737.9
- Received：27 December 2024，
  
  Revised：2025-01-21，
  
  Published：28 February 2025
- 稿件说明：
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Yongjin LU, Zhiqiang SHI, Tong LI, et al. Retrospective study on regional lymph node radiotherapy after axillary dissection exemption in breast cancer patients with sentinel lymph node positive status[J]. China Oncology, 2025, 35(2): 228-236.
DOI：

Yongjin LU, Zhiqiang SHI, Tong LI, et al. Retrospective study on regional lymph node radiotherapy after axillary dissection exemption in breast cancer patients with sentinel lymph node positive status[J]. China Oncology, 2025, 35(2): 228-236. DOI： 10.19401/j.cnki.1007-3639.2025.02.010.

摘要

背景与目的：

随着乳腺癌外科治疗逐步朝个体化、微创化方向发展，前哨淋巴结活检（sentinel lymph node biopsy，SLNB）已取代腋窝淋巴结清扫术（axillary lymph node dissection，ALND）成为部分早期乳腺癌患者的标准腋窝处理方法。然而，对于前哨淋巴结（sentinel lymph node，SLN）阳性未行ALND的患者是否需要区域淋巴结照射（regional lymph node irradiation，RNI），临床上尚存在争议。本研究旨在分析SLN阳性未行ALND患者的临床病理学特征及预后情况，评估RNI的临床应用价值，为此类患者的临床治疗决策提供证据支持。

方法：

本单中心回顾性队列研究筛选了2014年9月1日—2023年8月31日在山东省肿瘤医院接受SLNB的乳腺癌患者，所有患者均已签署治疗知情同意书。依据术后放疗是否包括区域淋巴结[内乳和（或）腋窝和（或）锁骨上下

]

照射野，分为RNI组和no-

RNI组，并进行一系列随访。此外，根据乳房手术方式、肿瘤分子分型以及组织学分级等因素，将患者进一步划分为多个亚组，比较各亚组之间RNI的临床价值。主要终点为无区域复发生存（locoregional recurrence-free survival，LRRFS），次要终点为无浸润性疾病复发生存（invasive disease-free survival，iDFS）和总生存（overall survival，OS）率。本研究严格遵循《加强流行病学中观察性研究报告质量》（Strengthening the Reporting of Observational Studies in Epidemiology，STROBE）指南中的各项条目。

结果：

本研究筛选了8 328例乳腺癌患者的临床资料，根据入组和排除标准，356例患者最终纳入分析，其中RNI组186例，no-RNI组170例。两组在年龄、体重指数（body mass index，BMI）、绝经状态、肿瘤位置、病理学类型、组织学分级、淋巴管血管侵犯、雌激素受体（estrogen receptor，ER）和孕激素受体（progesterone receptor，PR）状态以及人类表皮生长因子受体2（human epidermal growth factor receptor 2，HER-2）表达情况方面差异无统计学意义（

0.05），但RNI组患者的阳性SLN数量、肿瘤T分期和全乳切除术（total mastectomy，TM）占比显著高于no-RNI组（

=0.006、

=0.043、

0.001）。中位随访38个月后，RNI组未观察到任何复发或转移病例，而no-RNI组的复发转移率为3.5%（6/170）。其中，4例仅出现局部区域复发，2例发生远处转移。RNI组在iDFS方面优于no-RNI组（

=0.017），但LRRFS和OS方面差异无统计学意义（

=0.051和

=0.356）。探索性亚组分析显示，肿瘤直径

2 cm（

=0.033）、分子分型为三阴性乳腺癌（triple-negative breast cancer，TNBC）（

=0.020）的患者在LRRFS方面可能从RNI治疗中获益。

结论：

对于某些高危患者，如肿瘤直径较大、分子分型为TNBC或non-SLN高转移风险的患者，RNI在降低乳腺癌复发转移风险方面仍然具有重要意义。临床实践中应结合患者的淋巴结残留肿瘤负荷、肿瘤的生物学行为及手术方式制定个体化的RNI策略。

Abstract

Background and purpose:

With the progressive development of breast cancer surgery toward more individualized and minimally invasive approaches

sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as the standard method for axillary management in certain early-stage breast cancer patients. However

there is ongoing debate in clinical practice regarding whether regional lymph node irradiation (RNI) is necessary for patients with sentinel lymph node (SLN) positive status who have not undergone ALND. This study aimed to analyze the clinicopathological features and survival prognosis of patients with SLN-positive status who did not undergo ALND

evaluate the clin

ical application value of RNI

and provide evidence to support clinical treatment decisions for this group of patients.

Methods:

This single-center retrospective study screened breast cancer patients who underwent SLNB at Shandong Cancer Hospital from September 1

2014

to August 31

2023. All patients signed informed consent for treatment. Based on whether postoperative radiotherapy included regional lymph node irradiation (internal mammary and/or axillary and/or supra-/infra-clavicular fields)

patients were divided into the RNI group and the no-RNI group for follow-up. Additionally

patients were further divided into multiple subgroups based on factors such as the type of breast surgery

tumor molecular subtype

and histological grade

to compare the clinical value of RNI among subgroups. The primary endpoint was locoregional recurrence-free survival (LRRFS)

and the secondary endpoints included invasive disease-free survival (iDFS) and overall survival (OS). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was followed for this study.

Results:

Clinical data of 8 328 breast cancer patients’ were screened for this study

and after applying inclusion and exclusion criteria

356 patients were included in the analysis

with 186 in the RNI group and 170 in the no-RNI group. There were no significant differences between the two groups in terms of age

body mass index (BMI)

menopausal status

tumor location

pathological type

histological grade

vascular invasion

estrogen receptor (ER) and progesterone receptor (PR) status

and human epidermal growth factor receptor 2 (HER-2) expression (

0.05). However

the number of positive SLNs

T stage

and the proportion of patients undergoing total mastectomy (TM) were significantly higher in the RNI group than in the no-RNI group (

=0.006

=0.043

0.001). After a median follow-up of 38 months

no recurrence or metastasis was obs

erved in the RNI group

while the recurrence and metastasis rate in the no-RNI group was 3.5% (6/170). Of these

4 cases had local regional recurrence

and 2 had distant metastasis. The RNI group showed superior iDFS compared to the no-RNI group (

=0.017)

however there was no statistically significant difference in LRRFS and OS (

=0.051 and

=0.356). Exploratory subgroup analysis indicated that patients with tumor diameter

2 cm (

=0.033) and triple-negative molecular (TNBC) (

=0.020) might benefit from RNI treatment in terms of LRRFS.

Conclusion:

For certain high-risk patients

such as those with larger tumor diameter

TNBC

or high non-SLN metastatic risk

RNI still plays an important role in reducing the risk of recurrence and metastasis in breast cancer. In clinical practice

an individualized RNI strategy should be developed based on the patient's residual lymph node tumor load

biological behavior of the tumor

and surgical method.

关键词

Keywords

references

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