DataSheet_1_The prognostic analysis of further axillary dissection in breast cancer with 1-2 positive sentinel lymph nodes undergoing mastectomy.zip

BackgroundThe ACOSOG Z0011 study has shown that axillary lymph node dissection (ALND) is an option to be considered in patients who had 1-2 metastatic sentinel lymph nodes (SLNs) who proceed with breast-conserving along with postoperative radiotherapy. However, there remains controversy regarding the applicability of this approach in patients who had a mastectomy. The aim of our study is to determine the prognostic differences and risk factors associated with the decision to opt for ALND in breast cancer patients who had 1-2 metastatic SLNs who receive a mastectomy.
MethodsThe study conducted a retrospective analysis of patients diagnosed with cT1-2N0 breast cancer and treated at The Fourth Hospital of Hebei Medical University between January 2016 and December 2021, and patients were divided into two cohorts according to whether ALND was performed after sentinel lymph node biopsy (SLNB): SLNB cohort and SLNB + ALND cohort. Outcomes included the locoregional recurrence rate (LRR), disease-free survival (DFS), and overall survival (OS). Propensity score matching (PSM) was conducted to ensure the balance of variables between the two cohorts. Cox proportional hazard models were employed to ascertain the univariate and multivariate relative risks associated with survival.
ResultsThere were 812 cases enrolled. After the PSM, 234 receiving ALND and 234 not receiving ALND were matched. A median follow-up period of 56.72 ± 20.29 months was observed. During that time, no significant difference was identified in the DFS and OS in the SLNB + ALND cohort and the SLNB cohort (P = 0.208 and P = 0.102), except for those under 40 years old, SLNB + ALND group showed a reduction in LRR compared to SLNB group (11.1% vs. 2.12%, P = 0.044). Multivariate Cox analysis showed that younger (≤ 40 years), progesterone receptor (PR)-negative, and SLNB alone were independent risk factors for LRR; perineural invasion was a risk factor, while endocrinotherapy was a beneficial prognostic indicator for DFS and OS among patients with positive hormone receptor.
ConclusionALND does not impact DFS and OS in patients with 1-2 metastatic SLNs who have completed a mastectomy. Being younger (≤ 40 years), having a negative PR, and undergoing SLNB alone were independent risk factors for LRR. Given this finding, we recommend avoiding axillary treatment such as ALND or radiotherapy in patients without risk factors.

研究背景：ACOSOG Z0011研究已证实，对于接受保乳手术联合术后放疗且存在1~2枚转移性前哨淋巴结（sentinel lymph node, SLN）的乳腺癌患者，腋窝淋巴结清扫（axillary lymph node dissection, ALND）是可供选择的治疗方案。但对于接受乳房切除术的患者，该方案的适用性仍存在争议。本研究旨在明确接受乳房切除术且存在1~2枚转移性SLN的乳腺癌患者中，选择ALND与否的预后差异及相关危险因素。
研究方法：本研究回顾性分析了2016年1月至2021年12月在河北医科大学第四医院收治的cT1-2N0期乳腺癌患者，根据前哨淋巴结活检（sentinel lymph node biopsy, SLNB）后是否行ALND将患者分为两组：SLNB组与SLNB+ALND组。研究结局指标包括局部区域复发率（locoregional recurrence rate, LRR）、无病生存期（disease-free survival, DFS）及总生存期（overall survival, OS）。为确保两组间基线变量均衡，本研究采用倾向得分匹配（propensity score matching, PSM）进行校正，并采用Cox比例风险模型分别分析与生存相关的单因素及多因素相对风险。
研究结果：本研究共纳入812例患者。经PSM匹配后，ALND组与非ALND组各234例。中位随访时间为56.72±20.29个月。随访期间，SLNB+ALND组与SLNB组的DFS及OS均无显著差异（P=0.208、P=0.102）；但在年龄≤40岁的亚组中，SLNB+ALND组的LRR显著低于SLNB组（11.1% vs. 2.12%，P=0.044）。多因素Cox分析显示，年龄较小（≤40岁）、孕激素受体（progesterone receptor, PR）阴性以及仅行SLNB是LRR的独立危险因素；神经周围侵犯亦是LRR的危险因素，而内分泌治疗对于激素受体阳性患者的DFS及OS具有保护性预后价值。
研究结论：对于接受乳房切除术且存在1~2枚转移性SLN的乳腺癌患者，ALND对其DFS及OS无显著影响。年龄≤40岁、PR阴性以及仅行SLNB是LRR的独立危险因素。基于上述结果，我们建议对于无上述危险因素的患者，可避免ALND或放疗等腋窝区域治疗。