Vernet-Tomás Maria, Argudo Nuria, Jimenez Marta, Masó Paula, De Miguel Maite, Martínez Anabel, Vidal-Sicart Sergi, Aguilar Yolanda, Rubio Lourdes, Valhondo Raquel, Alcantara Rodrigo, Arenas Natalia, Pitarch Mireia, de Las Heras Ivonne Vázquez, Comerma Laura, Sanz Javier, Algara Manuel, Noguera Alicia, Nicolau Pau
Breast Diseases Unit, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.
Department of General Surgery, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.
Gland Surg. 2023 Feb 28;12(2):140-151. doi: 10.21037/gs-22-480. Epub 2023 Feb 2.
Some studies suggested that the patients included in the Z0011 trial may represent patients with ultrasound-negative axillary nodes and axillary invasion diagnosed by sentinel node (SN) biopsy. Nevertheless, the National Comprehensive Cancer Network (NCCN) guidelines recommend SN mapping if 1 or 2 suspicious lymph nodes are identified on axillary ultrasound (AU). The aim of this preliminary phase of the Multimodal Targeted Axillary Surgery (MUTAS) trial was to establish the accuracy of SN mapping in patients with axillary involvement undergoing upfront surgery.
Between September 2019 and March 2022, we recruited patients with biopsy-proven metastatic axillary nodes and upfront surgery from a single center. We performed SN mapping in these patients before the surgical intervention, which included axillary lymph node dissection. The biopsy-proven metastatic node, SNs and the remaining axillary nodes were excised separately. SN status was considered representative of the status of the remaining axillary nodes. We calculated the sensitivity, specificity, negative predictive value and positive predictive value of the SN, overall and in patients with palpable nodes, in those with non-palpable nodes and an AU leading to diagnosis of axillary involvement, in those with 1 or 2 suspicious nodes on AU, and in patients with a single suspicious node on AU. We evaluated clinical, imaging and pathology features as predictors of the status of the remaining axillary nodes, false-negatives, and false-positives.
We included 25 patients in this phase. The false-negative rate of SN mapping was 28% overall, 21.42% for patients with palpable nodes, 36.36% for patients with non-palpable nodes and an AU diagnosis of axillary involvement, 28.75% for those with 1 or 2 suspicious nodes on AU, and 15.38% in patients with a single suspicious node on AU. The negative predictive value was highest in patients with a single suspicious node on AU (75%). The only significant predictive factor was that FN showed a higher Ki67 index score.
In this study, SN mapping was not reliable in patients with biopsy-proven metastatic axillary nodes and upfront surgery for any of the subgroups studied. Further research should elucidate the best staging pathways in these patients to avoid premature de-escalation.
一些研究表明，Z0011试验纳入的患者可能代表经前哨淋巴结（SN）活检诊断为超声阴性腋窝淋巴结且有腋窝侵犯的患者。然而，美国国立综合癌症网络（NCCN）指南建议，如果在腋窝超声（AU）检查中发现1个或2个可疑淋巴结，则进行SN定位。多模式靶向腋窝手术（MUTAS）试验这一初步阶段的目的是确定在接受 upfront 手术的腋窝受累患者中SN定位的准确性。
2019年9月至2022年3月期间，我们从单一中心招募了经活检证实有转移性腋窝淋巴结且接受 upfront 手术的患者。在手术干预（包括腋窝淋巴结清扫）前，我们对这些患者进行了SN定位。分别切除经活检证实的转移性淋巴结、前哨淋巴结和其余腋窝淋巴结。SN状态被认为代表其余腋窝淋巴结的状态。我们计算了SN的敏感性、特异性、阴性预测值和阳性预测值，包括总体情况以及可触及淋巴结的患者、不可触及淋巴结且AU检查诊断为腋窝受累的患者、AU检查发现1个或2个可疑淋巴结的患者以及AU检查发现单个可疑淋巴结的患者。我们评估了临床、影像学和病理特征作为其余腋窝淋巴结状态、假阴性和假阳性的预测因素。
本阶段我们纳入了25例患者。SN定位的总体假阴性率为28%，可触及淋巴结的患者为21.42%，不可触及淋巴结且AU诊断为腋窝受累的患者为36.36%，AU检查发现1个或2个可疑淋巴结的患者为28.75%，AU检查发现单个可疑淋巴结的患者为15.38%。AU检查发现单个可疑淋巴结的患者阴性预测值最高（75%）。唯一显著的预测因素是假阴性（FN）显示较高的Ki67指数评分。
在本研究中，对于经活检证实有转移性腋窝淋巴结且接受 upfront 手术的任何研究亚组患者，SN定位均不可靠。进一步的研究应阐明这些患者的最佳分期途径，以避免过早降级。
