Z0011时代前哨淋巴结阳性后省略腋窝淋巴结清扫术：大型前瞻性队列中对美国国立综合癌症网络（NCCN）和美国临床肿瘤学会（ASCO）临床指南及Z0011标准的遵循情况
Omitting axillary lymph node dissection after positive sentinel lymph node in the post-Z0011 era: Compliance with NCCN and ASCO clinical guidelines and Z0011 criteria in a large prospective cohort.
作者信息
Costaz Hélène, Boulle Delphine, Bertaut Aurélie, Rouffiac Magali, Beltjens Françoise, Desmoulins Isabelle, Peignaux Karine, Ladoire Sylvain, Causeret Sylvain, Loustalot Catherine, Padeano Marie-Martine, Vincent Laura, Jankowski Clémentine, Arnould Laurent, Coutant Charles
机构信息
Georges-François Leclerc cancer center, department of surgical oncology, 21000 Dijon, France.
Georges-François Leclerc cancer center, department of surgical oncology, 21000 Dijon, France.
出版信息
Bull Cancer. 2022 Mar;109(3):268-279. doi: 10.1016/j.bulcan.2021.09.018. Epub 2021 Nov 24.
PURPOSE
In the ACOSOG Z0011 trial, patients with primary breast cancer and 1-2 tumor-involved sentinel lymph nodes (SLNs) undergoing breast-conserving surgery had no oncological outcome benefit after axillary lymph node dissection (ALND), despite a relevant rate of non-SLN metastases of 27%. According to the St Gallen expert consensus, and NCCN and ASCO clinical guidelines, ALND may be avoided in patients who meet all ACOSOG Z0011 inclusion criteria. This recommendation can also be extended to patients undergoing mastectomy, with 1 or 2 positive SLNs and an indication for chest wall radiation, in whom axillary radiotherapy can be proposed as an alternative to completion ALND. The aim of this study was to assess non-compliance with the NCCN and ASCO clinical guidelines and Z0011 criteria, namely the rate of performance of completion ALND when it was not recommended, and the rate of failure to perform completion ALND when recommended.
METHODS
Data were prospectively analysed from T1-2 N0 breast cancer patients undergoing an SLN procedure and treated at the Georges-François Leclerc Cancer Center between November 2015 and May 2017. Factors associated with non-compliance treatment decisions were identified using logistic regression.
RESULTS
Among 563 patients included, 122 (21.7%) had at least one positive SLN. ALND was not recommended for 76 patients (62.3%), and was recommended in 46 patients (37.7%). The rate of non-compliant treatment was 32% (39/122) overall: ALND was performed despite not being recommended in 16/76 patients (21.1%) and was not performed in 50% of patients in whom it was recommended (23/46). By multivariate analyses, lymphovascular invasion ((Odds Ratio (OR)=6.1; 95% confidence interval (CI): 1.4-26.7; P=0.02)) and only one SLN removed (OR=9.1; 95%CI: 2.2-33.3; P=0.002) were associated with performance of completion ALND when not recommended. Conversely, >1 SLN removed (OR=5.1; 95%CI: 1.2-22.2; P=0.03) was associated with the failure to perform completion ALND when recommended.
CONCLUSION
Almost one third of patients with invasive breast cancer receive treatment that is not in compliance with recommendations regarding completion ALND.
目的
在ACOSOG Z0011试验中，接受保乳手术且有1 - 2个前哨淋巴结（SLN）有肿瘤累及的原发性乳腺癌患者，尽管非前哨淋巴结转移率达27%，但腋窝淋巴结清扫（ALND）后并未获得肿瘤学结局益处。根据圣加仑专家共识以及美国国立综合癌症网络（NCCN）和美国临床肿瘤学会（ASCO）的临床指南，符合ACOSOG Z0011所有纳入标准的患者可避免行ALND。该推荐也可扩展至接受乳房切除术、有1或2个SLN阳性且有胸壁放疗指征的患者，对于这些患者可建议行腋窝放疗以替代完成ALND。本研究的目的是评估不符合NCCN和ASCO临床指南及Z0011标准的情况，即不建议行ALND时完成ALND的实施率，以及建议行ALND时未完成ALND的发生率。
方法
对2015年11月至2017年5月在乔治 - 弗朗索瓦·勒克莱尔癌症中心接受SLN手术并治疗的T1 - 2 N0期乳腺癌患者的数据进行前瞻性分析。使用逻辑回归确定与不符合治疗决策相关的因素。
结果
在纳入的563例患者中，122例（21.7%）至少有1个阳性SLN。76例患者（62.3%）不建议行ALND，46例患者（37.7%）建议行ALND。总体不符合治疗率为32%（39/122）：16/76例患者（21.1%）尽管不建议仍进行了ALND，而建议行ALND的患者中有50%（23/46）未进行。多因素分析显示，淋巴管浸润（比值比（OR）=6.1；95%置信区间（CI）：1.4 - 26.7；P = 0.02）和仅切除1个SLN（OR = 9.1；95%CI：2.2 - 33.3；P = 0.002）与不建议时完成ALND的实施相关。相反，切除>1个SLN（OR = 5.1；95%CI：1.2 - 22.2；P = 0.03）与建议时未完成ALND相关。
结论
几乎三分之一的浸润性乳腺癌患者接受的治疗不符合关于完成ALND的推荐。
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