新辅助治疗后腋窝淋巴结阳性乳腺癌患者应用碳标记行靶向腋窝淋巴结清扫术（TADCOM）的前瞻性、多中心、随机对照研究方案

Targeted axillary dissection using carbon marking for patients with node-positive breast cancer following neoadjuvant therapy (TADCOM): study protocol for a prospective, multicenter, randomized controlled trial.

机构信息

Department of Breast Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310008, Zhejiang, China.

Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.

出版信息

BMC Cancer. 2024 Oct 15;24(1):1276. doi: 10.1186/s12885-024-13001-2.

DOI:10.1186/s12885-024-13001-2

PMID:39402559

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11479563/

Abstract

BACKGROUND

Neoadjuvant chemotherapy (NAC) for breast cancer enables pathological complete response (pCR) in patients initially diagnosed with axillary lymph node metastases, potentially obviating the need for axillary lymph node dissection (ALND). Current targeted axillary dissection (TAD) techniques, guided by traditional tissue markers placed prior to NAC, face challenges such as marker loss and high costs. Carbon nanoparticle suspension injection (CNSI) offers a stable and reliable alternative for marking, which could enhance the TAD procedure. This study aims to evaluate the feasibility and accuracy of different TAD strategies using CNSIs and to explore their clinical utility in locally advanced breast cancer.

METHODS

This prospective, multicenter, randomized controlled trial will enroll 126 biopsy-proven breast cancer patients with suspicious axillary lymph node metastases (cN1-2a) who achieve ycN0 status following NAC. Participants will be randomized in a 1:1:1 ratio to undergo TAD guided by: [1] conventional tissue clips (CG-TAD); [2] CNSI lymph node marking (CN-LNM); or [3] peritumoral CNSI mapping (PCN-MAP). Primary endpoints include retrieval rate of marked lymph nodes, number of sentinel and marked lymph nodes, concordance rates, and complication rates. Secondary endpoints encompass regional and distant recurrence rates, survival outcomes, surgical duration, postoperative complications, quality of life scores, and margin status in breast-conserving surgery. Statistical analyses will adhere strictly to the CONSORT guidelines.

DISCUSSION

This study aims to evaluate the feasibility and accuracy of CNSI for targeted axillary dissection in breast cancer patients following neoadjuvant chemotherapy and to explore its clinical significance in reducing surgical complications and costs, as well as improving surgical precision.

TRIAL REGISTRATION

Clinicaltrials.gov, NCT04744506, Registered 27 December 2020, Updated 24 September 2024. Protocol Version Ver 1.2, 17/9/2024.

摘要

背景

新辅助化疗（NAC）可使最初诊断为腋窝淋巴结转移的患者达到病理完全缓解（pCR），从而可能避免腋窝淋巴结清扫（ALND）。目前，在 NAC 之前使用传统组织标志物引导的靶向腋窝解剖（TAD）技术面临标志物丢失和高成本等挑战。碳纳米粒子混悬液注射（CNSI）为标记提供了一种稳定可靠的替代方法，可增强 TAD 手术的效果。本研究旨在评估使用 CNSI 的不同 TAD 策略的可行性和准确性，并探讨其在局部晚期乳腺癌中的临床应用价值。

方法

这是一项前瞻性、多中心、随机对照临床试验，将纳入 126 例经活检证实的乳腺癌患者，这些患者经 NAC 后腋窝淋巴结转移（cN1-2a）降为 ycN0 状态。参与者将按照 1:1:1 的比例随机分为三组，分别接受以下 TAD 策略：[1] 常规组织夹（CG-TAD）；[2] CNSI 淋巴结标记（CN-LNM）；或 [3] 肿瘤周围 CNSI 图谱（PCN-MAP）。主要终点包括标记淋巴结的检出率、前哨和标记淋巴结的数量、一致性率和并发症发生率。次要终点包括区域和远处复发率、生存结局、手术时间、术后并发症、生活质量评分和保乳手术中的切缘状态。统计分析将严格遵循 CONSORT 指南。