美国外科医师学会肿瘤学组 (ACOSOG) Z0011 排除可触及淋巴结，而 SINODAR-ONE 排除触诊和超声检查腋窝淋巴结阳性的患者。为了确定临床淋巴结状态是否应排除在满足 ACOSOG Z0011 和类似试验的病理标准的患者中，本研究分析了临床淋巴结阳性的准确性和影响。 ≥ 18 岁的 cT1-T2、cN0-cN1、M0 乳腺癌患者2004 年至 2019 年间，在国家癌症数据库中确定了 cN1 和 cN0 的子集特征，比较了最终病理淋巴结状态和总生存期 (OS)。在确定的 57,823 名患者中，77.0% 为 cT1，23.0% 为 cT2。 93.9% 的分期为 cN0 的患者中，16.7% 为 pN1；其余 6.1% 为 cN1，其中 9.6% 为 pN0。在 cN1/pN0 患者中，14.9% 的患者接受了腋窝淋巴结清扫术，但未进行前哨淋巴结活检。对于分期为 cN0 的患者与分期为 pN1 的 cN1 患者，调整后的 OS 没有差异（HR 1.13，95% CI 0.93-1.37，p = 0.22），这一发现在具有两个阳性淋巴结的患者的子集分析中仍然存在（ 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会夸大患者的分期并导致不必要的腋窝手术。这些数据表明，在其他方面属于 Z0011 样范式候选者的 cN1 患者仍应被视为符合资格。他们的最终候选资格应根据手术淋巴结病理学而不是术前临床状态来确定。© 2024。外科肿瘤学会。

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.© 2024. Society of Surgical Oncology.