4541名淋巴结阳性乳腺癌患者接受新的全身治疗和3d放射治疗（DBCG IMN2）的乳房内淋巴结照射：一项前瞻性、全国性、基于人群的队列研究。

IF 13.6 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2025-02-01 DOI:10.1016/j.lanepe.2024.101160

Anders W. Mølby Nielsen , Lise B.J. Thorsen , Demet Özcan , Louise W. Matthiessen , Else Maae , Marie L.H. Milo , Mette H. Nielsen , Trine Tramm , Jens Overgaard , Birgitte V. Offersen , DBCG RT Committee

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引用次数: 0

摘要

背景：乳腺内淋巴结照射（IMNI）可提高淋巴结阳性乳腺癌患者的总生存率（OS）。然而，在接受较新的全身疗法和基于3d的放疗（RT）治疗的乳腺癌患者中，没有记录到这种效果。因此，丹麦乳腺癌组（DBCG） IMN2研究旨在探讨IMNI对淋巴结阳性乳腺癌患者的影响。方法：DBCG IMN2是一项全国性的基于人群的队列研究，在6个RT中心前瞻性地将淋巴结阳性乳腺癌右侧肿瘤患者分配到IMNI，左侧肿瘤患者分配到无IMNI。排除标准为既往恶性肿瘤、双侧乳腺癌、新辅助全身治疗、放疗前复发或非标准放疗。全身治疗包括紫杉烷化疗、芳香酶抑制剂和曲妥珠单抗。主要终点为OS。次要终点是乳腺癌死亡率和远处转移。校正风险比（HR）采用Cox回归分析。Clinicaltrial.gov ID: NCT06549920。结果：2007年1月- 2014年5月共纳入4541例患者。患者特征在左右侧患者中分布均匀。OS的中位随访时间为13.7年。IMNI患者15年生存率为65.0%，未导致调整后风险比为0.85 (95% CI, 0.76-0.94；p = 0.0016)。相应的hr为0.84 (95% CI, 0.74-0.95；p = 0.0077)，相对危险度为0.87 (95% CI, 0.78-0.98；P = 0.026)远处转移。没有确定遗漏IMNI的亚组。右侧患者15年缺血性或瓣膜性心脏病的累计死亡发生率为0.2% (95% CI, 0.0-0.5)，左侧患者为0.7% （95% CI, 0.4-1.2）。结论：IMNI降低了淋巴结阳性乳腺癌患者的远处转移和乳腺癌死亡率，并改善了OS，尽管采用了较新的全身疗法和基于3d的rt治疗。资助：这项工作得到了丹麦癌症协会和丹麦奥胡斯大学临床医学系的支持。

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Internal mammary node irradiation in 4541 node-positive breast cancer patients treated with newer systemic therapies and 3D-based radiotherapy (DBCG IMN2): a prospective, nationwide, population-based cohort study

Background

Internal mammary node irradiation (IMNI) improves overall survival (OS) in node-positive breast cancer patients. However, the effect is not documented in breast cancer patients treated with newer systemic therapies and 3D-based radiotherapy (RT). Therefore, the Danish Breast Cancer Group (DBCG) IMN2 study aimed to investigate the effect of IMNI in node-positive breast cancer patients treated with newer systemic therapies and 3D-based RT.

Methods

DBCG IMN2 was a nationwide population-based cohort study prospectively allocating node-positive breast cancer patients with right-sided tumours to IMNI and patients with left-sided tumours to no IMNI in six RT centres. Exclusion criteria were prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before RT, or non-standard RT. Systemic treatment included taxane-based chemotherapy, aromatase inhibitors, and trastuzumab. The primary end-point was OS. Secondary endpoints were breast cancer mortality and distant metastasis. Cox regression analyses were used for adjusted hazard ratios (HR). Clinicaltrial.gov ID: NCT06549920.

Findings

In the period January 2007–May 2014, a total of 4541 patients were included. Patient characteristics were distributed evenly between right- and left-sided patients. Median follow-up was 13.7 years for OS. Survival rates at 15 years were 65.0% in patients with IMNI and 60.8% without leading to an adjusted HR of 0.85 (95% CI, 0.76–0.94; p = 0.0016) for OS. Corresponding HRs were 0.84 (95% CI, 0.74–0.95; p = 0.0077) for breast cancer mortality and HR 0.87 (95% CI, 0.78–0.98; p = 0.026) for distant metastasis. No subgroups were identified for the omission of IMNI. The 15-year cumulative incidence of death from ischemic or valvular heart disease was 0.2% (95% CI, 0.0–0.5) in right-sided and 0.7% (95% CI, 0.4–1.2) in left-sided patients.

Interpretation

IMNI reduced distant metastasis and breast cancer mortality and improved OS in node-positive breast cancer patients, despite treatment with newer systemic therapies and 3D-based RT.

Funding

This work was supported by the Danish Cancer Society and Department of Clinical Medicine, Aarhus University, Denmark.

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.