ER+HER2-乳腺癌的腋窝清除率和化疗率：SENOMAC 试验的二次分析

IF 13.6 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2024-09-26 DOI:10.1016/j.lanepe.2024.101083

Tove Filtenborg Tvedskov , Robert Szulkin , Sara Alkner , Yvette Andersson , Leif Bergkvist , Jan Frisell , Oreste Davide Gentilini , Michalis Kontos , Thorsten Kühn , Dan Lundstedt , Birgitte Vrou Offersen , Roger Olofsson Bagge , Toralf Reimer , Malin Sund , Lisa Rydén , Peer Christiansen , Jana de Boniface

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引用次数: 0

摘要

背景随机试验表明，前哨淋巴结阳性乳腺癌患者可以安全地省略腋窝清扫（AC）。同时，绝经后ER+HER2-乳腺癌患者化疗的降级可能取决于详细的腋窝结节分期。本研究对 SENOMAC 试验进行了预先指定的二次分析，旨在研究腋窝分期的选择是否会影响接受辅助化疗的患者比例以及无复发生存率（RFS）。方法对SENOMAC试验中2168例临床结节阴性ER+HER2-乳腺癌且有1-2个前哨淋巴结大转移的患者，根据AC或仅前哨淋巴结活检（SLNB）、绝经状态和纳入地区计算接受辅助化疗的比例。在绝经后患者中，接受化疗的比例因地区和国家不同而有很大差异（36.0%-82.4%）。在丹麦，539 名绝经后患者中有 194 人（36.0%）接受了辅助化疗，其中 AC 组和仅 SLNB 组的比例差异显著（41.3% vs 31.4%，p = 0.019）。丹麦绝经后患者的中位随访时间为 44.88 个月，5 年 RFS 无明显差异，仅 SLNB 治疗组为 91% (85.6%-96.6%)，AC 治疗组为 90.9% (86.3%-95.6%)（P = 0.42）。释义当省略腋窝清扫，从而降低手臂长期发病风险时，绝经后ER+HER2-乳腺癌患者潜在的治疗不足可能需要开发新的预测和成像工具。

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Axillary clearance and chemotherapy rates in ER+HER2− breast cancer: secondary analysis of the SENOMAC trial

Background

Randomized trials have shown that axillary clearance (AC) can safely be omitted in patients with sentinel lymph node-positive breast cancer. At the same time, de-escalation of chemotherapy in postmenopausal patients with ER+HER2− breast cancer may depend on detailed axillary nodal stage. The aim of this pre-specified secondary analysis of the SENOMAC trial was to investigate whether the choice of axillary staging affected the proportion of patients receiving adjuvant chemotherapy, and recurrence-free survival (RFS).

Methods

Proportion receiving adjuvant chemotherapy was calculated according to AC or sentinel lymph node biopsy (SLNB) only, menopausal status, and region of inclusion, for 2168 patients with clinically node-negative ER+HER2− breast cancer and 1–2 sentinel lymph node macrometastases included in the SENOMAC trial.

Findings

In premenopausal patients, 514 out of 615 patients (83.6%) received adjuvant chemotherapy with no significant difference between randomization arms. In postmenopausal patients, the proportion receiving chemotherapy varied considerably by region and country (36.0–82.4%). In Denmark, where 194 out of 539 postmenopausal patients (36.0%) received adjuvant chemotherapy, rates differed significantly between the AC and the SLNB only arm (41.3% vs 31.4%, p = 0.019). After a median follow-up of 44.88 months for Danish postmenopausal patients, no significant difference was seen in 5-year RFS, which was 91% (85.6%–96.6%) for the SLNB only and 90.9% (86.3%–95.6%) for the AC arm (p = 0.42).

Interpretation

When omitting axillary clearance, and thus reducing the risk of long-term arm morbidity, potential under-treatment of postmenopausal patients with ER+HER2− breast cancer may require the development of new predictive and imaging tools.

Funding

Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, Swedish Breast Cancer Association.

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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.