新辅助治疗后腋窝淋巴结阳性乳腺癌患者行靶向腋窝清扫术的安全性。

Safety of Targeted Axillary Dissection After Neoadjuvant Therapy in Patients With Node-Positive Breast Cancer.

机构信息

Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.

Department of Gynecology With Breast Center Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

出版信息

JAMA Surg. 2023 Aug 1;158(8):807-815. doi: 10.1001/jamasurg.2023.1772.

DOI:10.1001/jamasurg.2023.1772

PMID:37285140

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10248815/

Abstract

IMPORTANCE

The increasing use of neoadjuvant systemic therapy (NST) has led to substantial pathological complete response rates in patients with initially node-positive, early breast cancer, thereby questioning the need for axillary lymph node dissection (ALND). Targeted axillary dissection (TAD) is feasible for axillary staging; however, data on oncological safety are scarce.

OBJECTIVE

To assess 3-year clinical outcomes in patients with node-positive breast cancer who underwent TAD alone or TAD with ALND.

DESIGN, SETTING, AND PARTICIPANTS: The SenTa study is a prospective registry study and was conducted between January 2017 and October 2018. The registry includes 50 study centers in Germany. Patients with clinically node-positive breast cancer underwent clipping of the most suspicious lymph node (LN) before NST. After NST, the marked LNs and sentinel LNs were excised (TAD) followed by ALND according to the clinician's choice. Patients who did not undergo TAD were excluded. Data analysis was performed in April 2022 after 43 months of follow-up.

EXPOSURE

TAD alone vs TAD with ALND.

MAIN OUTCOMES AND MEASURES

Three-year clinical outcomes were evaluated.

RESULTS

Of 199 female patients, the median (IQR) age was 52 (45-60) years. A total of 182 patients (91.5%) had 1 to 3 suspicious LNs; 119 received TAD alone and 80 received TAD with ALND. Unadjusted invasive disease-free survival was 82.4% (95% CI, 71.5-89.4) in the TAD with ALND group and 91.2% (95% CI, 84.2-95.1) in the TAD alone group (P = .04); axillary recurrence rates were 1.4% (95% CI, 0-54.8) and 1.8% (95% CI, 0-36.4), respectively (P = .56). Adjusted multivariate Cox regression indicated that TAD alone was not associated with an increased risk of recurrence (hazard ratio [HR], 0.83; 95% CI, 0.34-2.05; P = .69) or death (HR, 1.07; 95% CI, 0.31-3.70; P = .91). Similar results were obtained for 152 patients with clinically node-negative breast cancer after NST (invasive disease-free survival: HR, 1.26; 95% CI, 0.27-5.87; P = .77; overall survival: HR, 0.81; 95% CI, 0.15-3.83; P = .74).

CONCLUSIONS AND RELEVANCE

These results suggest that TAD alone in patients with mostly good clinical response to NST and at least 3 TAD LNs may confer survival outcomes and recurrence rates similar to TAD with ALND.

摘要

重要性

新辅助全身治疗（NST）的应用日益增多，导致最初淋巴结阳性的早期乳腺癌患者的病理完全缓解率显著提高，从而质疑是否需要进行腋窝淋巴结清扫（ALND）。靶向腋窝解剖（TAD）可用于腋窝分期；然而，关于其肿瘤安全性的数据还很缺乏。

目的

评估仅接受 TAD 或 TAD 联合 ALND 的淋巴结阳性乳腺癌患者的 3 年临床结局。

设计、设置和参与者：SentA 研究是一项前瞻性注册研究，于 2017 年 1 月至 2018 年 10 月进行。该注册研究包括德国的 50 个研究中心。临床淋巴结阳性的乳腺癌患者在接受 NST 前接受最可疑的淋巴结（LN）夹闭。在 NST 后，根据临床医生的选择切除标记的 LN 和前哨 LN（TAD），然后进行 ALND。未接受 TAD 的患者被排除在外。数据分析于 2022 年 4 月在 43 个月的随访后进行。

暴露

仅 TAD 与 TAD 联合 ALND。

主要结局和测量

评估了 3 年的临床结局。

结果

在 199 名女性患者中，中位（IQR）年龄为 52（45-60）岁。共有 182 名患者（91.5%）有 1 至 3 个可疑 LN；119 名患者仅接受 TAD，80 名患者接受 TAD 联合 ALND。未调整的浸润性疾病无复发生存率在 TAD 联合 ALND 组为 82.4%（95%CI，71.5%-89.4%），在 TAD 组为 91.2%（95%CI，84.2%-95.1%）（P=0.04）；腋部复发率分别为 1.4%（95%CI，0-54.8%）和 1.8%（95%CI，0-36.4%）（P=0.56）。多变量调整后的 Cox 回归表明，TAD 单独治疗与复发风险增加无关（风险比[HR]，0.83；95%CI，0.34-2.05；P=0.69）或死亡风险增加无关（HR，1.07；95%CI，0.31-3.70；P=0.91）。在 NST 后 152 名临床淋巴结阴性乳腺癌患者中也获得了相似的结果（浸润性疾病无复发生存率：HR，1.26；95%CI，0.27-5.87；P=0.77；总生存：HR，0.81；95%CI，0.15-3.83；P=0.74）。