应否将可触及淋巴结排除在符合ACOSOG Z0011型试验候选患者之外？

Should Palpable Nodes Be Exclusionary in Patients Who Are Otherwise Candidates for ACOSOG Z0011-Type Trials?

ANNALS OF SURGICAL ONCOLOGY

影响因子:3.5

分区:医学2区 / 外科2区肿瘤学3区

发表日期:2024 Oct

作者: Cassandra L Cardarelli, Elissa C Dalton, Cecilia Chang, Austin D Williams, Allison A Aggon, Andrea S Porpiglia, Mary T Pronovost, Richard J Bleicher

DOI: 10.1245/s10434-024-15704-z

摘要

在美国外科医师协会肿瘤学组（ACOSOG）Z0011试验中，可触及淋巴结被排除在研究范围之外，而SINODAR-ONE试验则排除了通过触诊和超声检测出阳性的腋窝淋巴结患者。为确定临床淋巴结状态是否应在符合ACOSOG Z0011及类似试验的病理学标准患者中作为排除条件，本研究分析了临床淋巴结阳性诊断的准确性及其影响。筛选条件为2004年至2019年间在国家癌症数据库中识别的年龄≥18岁、患有cT1-T2、cN0-cN1、M0的乳腺癌患者。比较cN1与cN0患者的亚组特征，重点关注最终病理淋巴结状态和总体生存（OS）。在57,823名患者中，77.0%为cT1，23.0%为cT2。在被分期为cN0的患者中，93.9%中有16.7%为pN1；而在剩余的6.1%被分期为cN1的患者中，有9.6%被发现为pN0。在cN1/pN0患者中，有14.9%接受了腋窝清扫而未行哨兵淋巴结活检。对于被分期为cN0而最终病理为pN1的患者，其调整后的OS无显著差异（HR 1.13，95% CI 0.93-1.37，p=0.22），在两阳性淋巴结患者的亚组分析中，此结论依然成立（HR 0.91，95% CI 0.62-1.33，p=0.63）。临床淋巴结分期不影响pN1患者的OS。临床淋巴结评估可能导致患者被高估分期，亦可能引发不必要的腋窝手术。这些数据表明，符合Z0011类似方案的cN1患者，若其他条件符合，应仍被视为符合资格。最终的候选资格应由手术淋巴结病理结果决定，而非术前临床状态。

Abstract

Palpable nodes were exclusionary in American College of Surgeons Oncology Group (ACOSOG) Z0011, while SINODAR-ONE excluded those with positive axillary nodes by palpation and ultrasound. To determine whether clinical nodal status should be exclusionary in those fulfilling pathologic criteria for ACOSOG Z0011 and similar trials, this study analyzed the accuracy and implications of clinical nodal positivity.Patients ≥ 18 years old with cT1-T2, cN0-cN1, M0 breast cancer were identified in the National Cancer Database between 2004 and 2019. Subset characteristics of cN1 and cN0 were compared with respect to final pathologic nodal status and overall survival (OS).Of 57,823 patients identified, 77.0% were cT1 and 23.0% were cT2. Of the 93.9% of patients who were staged as cN0, 16.7% were pN1; of the remaining 6.1% staged as cN1, 9.6% were found to be pN0. Among cN1/pN0 patients, 14.9% underwent axillary dissection without sentinel node biopsy. There was no difference in adjusted OS for patients staged as cN0 versus cN1 who were found to be pN1 (HR 1.13, 95% CI 0.93-1.37, p = 0.22), a finding that persisted on subset analysis in those with two positive nodes (HR 0.91, 95% CI 0.62-1.33, p = 0.63).Clinical nodal stage does not affect OS in pN1 patients. Clinical nodal assessment can both overstage patients and result in unnecessary axillary surgery. These data suggest that cN1 patients who are otherwise candidates for a Z0011-like paradigm should still be considered eligible. Their final candidacy should be determined by surgical lymph node pathology and not preoperative clinical status.