对于ACOSOG Z0011型试验的候选者，可触及的淋巴结是否应该是排他性的？
Should Palpable Nodes Be Exclusionary in Patients Who Are Otherwise Candidates for ACOSOG Z0011-Type Trials?
影响因子:3.50000
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
摘要
在美国外科医生肿瘤学院（ACOSOG）Z0011中，可触及的节点是排他性的，而Sinodar-one则不包括那些通过触诊和超声检查的腋窝淋巴结阳性的人。为了确定在满足Acosog Z0011和类似试验的那些满足病理标准的临床结节状态，本研究分析了临床淋巴结阳性的准确性和含义。患者与CT1-T2，CN0-CN1，M0乳腺癌的患者与2004年的CN0-CN1，M0乳腺癌在2004年度和2019年相结合。最终的病理淋巴结状况和总生存期（OS）。发现57,823例患者，CT1为77.0％，CT2为23.0％。在上演CN0的93.9％的患者中，PN1为16.7％；在剩下的6.1％为CN1中，发现9.6％为PN0。在CN1/PN0患者中，有14.9％的患者没有前哨淋巴结活检。被发现为PN1的患者与CN1相比，调整的OS的调整OS没有差异（HR 1.13，95％CI 0.93-1.37，P = 0.22），这一发现持续存在于具有两个正节点的患者中的子集分析中，HR 0.91，95％CI 0.62-1.62-1.33，PNENED n.1ccl = 0.63，pn noctial nos。临床淋巴结评估既可以超过阶段患者，也可以导致不必要的腋窝手术。这些数据表明，否则为Z0011样范式候选的CN1患者仍应被认为是符合条件的。他们的最终候选人应由手术淋巴结病理学和术前临床状况确定。
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.