Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Institute of Medical Biometry and Informatics, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Breast Cancer Res Treat. 2019 Sep;177(2):457-467. doi: 10.1007/s10549-019-05327-4. Epub 2019 Jun 24.
In the ACOSOG Z0011 trial, patients with primary breast cancer (BC) and 1-2 tumor-involved sentinel lymph nodes (SLN) undergoing breast-conserving surgery gained no benefit from completing axillary lymph node dissection (cALND). This paper reports cALND rates performed in clinical routine on patients who would meet the Z0011 criteria. Further, patients still received cALND were analyzed concerning the number of non-sentinel metastases (NSM) to estimate occult axillary tumor burden.
Data were retrospectively analyzed from patients treated in 179 German breast centers between 2008 and 2015. Time-trend rates were determined for cALND regarding the presence of axillary macrometastases or micrometastases. Descriptive statistics were used to report the number of NSM depending on the number of SLN removed, tumor-involved SLN, tumor stage (pT1-2), and immunohistochemical subtype. Factors associated with NSM were identified using multivariable logistic regression.
Altogether, data for 188,909 patients were available, of whom 13,741 (7.3%) were identified eligible for the Z0011 criteria. For these patients, the cALND rate for macrometastases declined from 96.4% in 2008 to 49.7% in 2015, for micrometastases from 86.7 to 5.9%. In total 9773 patients still received cALND, 33.4% of whom had NSM. The NSM rates were: 38.8% for pN(1/1sn), 28.6% for pN(1/2sn), and 50.9% for pN(2/2sn). Hormone receptor (HR) positive/HER2+ showed the highest NSM rate (41.6%), HR-/HER2- the lowest rate (29.4%).
The rate of cALND for ACOSOG Z0011 eligible patients has decreased substantially in routine care in our nationwide cohort. Our data reveal a relatively high prevalence of additional axillary NSM tumor burden.
在 ACOSOG Z0011 试验中,接受保乳手术且存在 1-2 个肿瘤累及的前哨淋巴结(SLN)的原发性乳腺癌(BC)患者从完成腋窝淋巴结清扫术(cALND)中并未获益。本研究报告了在符合 Z0011 标准的患者中,在临床常规中进行 cALND 的比率。此外,对仍接受 cALND 的患者进行分析,以评估隐匿性腋窝肿瘤负荷的非前哨淋巴结转移(NSM)数量。
本研究回顾性分析了 2008 年至 2015 年期间在 179 家德国乳腺中心接受治疗的患者数据。针对存在腋窝大转移灶或微转移灶的患者,确定 cALND 的时间趋势率。使用描述性统计数据报告取决于 SLN 切除数量、肿瘤累及 SLN、肿瘤分期(pT1-2)和免疫组织化学亚型的 NSM 数量。使用多变量逻辑回归确定与 NSM 相关的因素。
共纳入 188909 例患者,其中 13741 例(7.3%)符合 Z0011 标准。对于这些患者,大转移灶的 cALND 率从 2008 年的 96.4%下降至 2015 年的 49.7%,微转移灶的 cALND 率从 86.7%下降至 5.9%。共有 9773 例患者仍接受 cALND,其中 33.4%有 NSM。NSM 率为:pN(1/1sn)为 38.8%,pN(1/2sn)为 28.6%,pN(2/2sn)为 50.9%。激素受体(HR)阳性/HER2+的 NSM 率最高(41.6%),HR-/HER2-的 NSM 率最低(29.4%)。
在我们的全国性队列中,符合 ACOSOG Z0011 标准的患者接受 cALND 的比率在常规治疗中已大幅下降。我们的数据显示,隐匿性腋窝 NSM 肿瘤负荷的比例相对较高。