Department of Surgery, Michigan Medicine, Ann Arbor.
Center for Health Outcomes and Policy, Michigan Medicine, Ann Arbor.
JAMA Netw Open. 2024 Nov 4;7(11):e2446345. doi: 10.1001/jamanetworkopen.2024.46345.
The American College of Surgeons (ACS) operative standards were established to detail critical elements of cancer surgery, reduce technical variation, and improve outcomes. Two of the 6 operative standards target adequate axillary surgery for breast cancer. The potential association of the operative standards with short-term oncologic outcomes, such as nodal yield and nodal positivity rates, is currently unknown.
To evaluate the potential association of the ACS operative standards with short-term oncologic outcomes in breast cancer.
DESIGN, SETTING, AND PARTICIPANTS: A cohort study was performed using data on 1 201 317 women 18 years or older who underwent sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) for invasive breast cancer from January 1, 2012, to December 31, 2020. Patients were identified using the National Cancer Database (NCDB), a clinical oncology database encompassing approximately 70% of new cancer diagnoses, sourced from hospital registry data from 1317 facilities. Statistical analysis was performed from October 2023 to June 2024.
Sentinel lymph node biopsy or ALND.
Reliability-adjusted facility-level lymph node yield and nodal positivity rate for each procedure were calculated using generalized linear mixed models, Poisson regression, and logistic regression with facility-level random intercepts.
The cohort included 1 201 317 women with a median age of 62 years (IQR, 53-70 years). Facility-level nodal yield ranged from 1 to 6 for SLNB and from 6 to 22 for ALND. Median facility-level nodal yield for SLNB was 2.6 (IQR, 2.3-3.0) and the nodal positivity rate for SLNB was 12.2% (IQR, 11.0%-13.7%), with rates ranging from 6% to 21%. A weak correlation between facility-level lymph node yield and nodal positivity was observed (Spearman correlation coefficient, 0.17). Median nodal upstaging rate (≥4 positive nodes) for ALND was 30.5% (IQR, 26.5%-35.0%), with rates ranging from 11% to 54%; median nodal yield was 12.2 (IQR, 10.9-13.6). A strong correlation between nodal yield and nodal upstaging rates was observed (Spearman correlation coefficient, 0.53).
In this cohort study of women undergoing axillary surgery for invasive breast cancer, facility-level variation in lymph node yield was present for both SLNB and ALND, which could potentially be improved through the ACS operative standards. However, this variation had mixed associations with nodal positivity and upstaging rates, suggesting the association of the ACS operative standards with oncologic outcomes may be mixed.
美国外科医师学院（ACS）的手术标准旨在详细说明癌症手术的关键要素，减少技术差异，并改善结果。其中 6 项手术标准中有 2 项针对乳腺癌的充分腋窝手术。目前尚不清楚这些手术标准与短期肿瘤学结果（如淋巴结产量和淋巴结阳性率）之间的潜在关联。
评估 ACS 手术标准与乳腺癌短期肿瘤学结果之间的潜在关联。
设计、地点和参与者：使用 2012 年 1 月 1 日至 2020 年 12 月 31 日期间 1201317 名 18 岁或以上接受前哨淋巴结活检（SLNB）或腋窝淋巴结清扫术（ALND）的浸润性乳腺癌患者的数据进行了一项队列研究。患者通过国家癌症数据库（NCDB）确定，该数据库是一个临床肿瘤学数据库，涵盖了大约 70%的新癌症诊断，来源于来自 1317 个设施的医院登记数据。统计分析于 2023 年 10 月至 2024 年 6 月进行。
SLNB 或 ALND。
使用广义线性混合模型、泊松回归和具有设施水平随机截距的逻辑回归，计算每个程序的可靠性调整后的设施水平淋巴结产量和淋巴结阳性率。
该队列包括 1201317 名中位年龄为 62 岁（IQR，53-70 岁）的女性。SLNB 的设施水平淋巴结产量范围为 1 至 6，ALND 的产量范围为 6 至 22。SLNB 的中位设施水平淋巴结产量为 2.6（IQR，2.3-3.0），SLNB 的淋巴结阳性率为 12.2%（IQR，11.0%-13.7%），比例为 6%至 21%。观察到设施水平淋巴结产量与淋巴结阳性率之间存在弱相关性（Spearman 相关系数，0.17）。ALND 的中位淋巴结升级率（≥4 个阳性淋巴结）为 30.5%（IQR，26.5%-35.0%），比例为 11%-54%；中位淋巴结产量为 12.2（IQR，10.9-13.6）。观察到淋巴结产量与淋巴结升级率之间存在很强的相关性（Spearman 相关系数，0.53）。
在这项对接受浸润性乳腺癌腋窝手术的女性进行的队列研究中，SLNB 和 ALND 的淋巴结产量都存在设施水平的差异，这可能通过 ACS 手术标准得到改善。然而，这种差异与淋巴结阳性率和升级率的相关性混杂，这表明 ACS 手术标准与肿瘤学结果之间的关联可能是混杂的。
