van Hemert Annemiek K E, van Loevezijn Ariane A, Baas Marie-Sophie P D, Stokkel Marcel P M, Groen Emma J, van der Noort Vincent, Loo Claudette E, Sonke Gabe S, Russell Nicola, van Duijnhoven Frederieke H, Vrancken Peeters Marie-Jeanne T F D
Department of Surgical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.
Department of Nuclear Medicine, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.
Breast. 2025 Apr;80:104411. doi: 10.1016/j.breast.2025.104411. Epub 2025 Feb 4.
Axillary lymph node staging techniques after primary systemic therapy (PST) show low false negative rates, stimulating the omission of axillary lymph node dissection (ALND). Breast cancer patients with extensive nodal disease are underreported in studies on response-guided axillary treatment. In this study, we present the oncologic outcome of breast cancer patients with ≥4 involved axillary lymph nodes treated according to the MARI-protocol.
This prospective single arm registration study included breast cancer patients with extensive nodal disease defined as ≥4 involved axillary lymph nodes on FDG-PET/CT pre-PST between July 2014 and December 2021. After PST, the marked (MARI) lymph node was excised. Patients with a pathologic complete response (pCR) of the MARI node (ypN0) received locoregional radiation treatment (RT). In patients with residual disease of the MARI node (ypN+), ALND was performed followed by RT. Primary endpoint was axillary recurrence rate. Secondary endpoints were invasive disease-free survival (DFS) and overall survival (OS).
In total, 218 patients were registered of which 39 % of patients also had extra-axillary nodal disease. Median (IQR) age was 50 (42-57) years. After PST 47 % of patients (103/218) had ypN0, whereas 53 % of patients (115/218) had ypN+. After a median follow up of 44 (26-62) months, axillary recurrence rate was 2.9 % (n = 3) in the ypN0 group and 3.5 % (n = 4) in the ypN + group. Five-year invasive DFS and OS were respectively 89 % (95 % CI 83 %-96 %) and 95 % (95 % CI 91 %-99 %) in ypN0 patients.
Omission of ALND after PST in breast cancer patients with extensive nodal involvement who achieve pCR of the MARI node is associated with excellent five-year oncologic outcome.
初次全身治疗（PST）后的腋窝淋巴结分期技术显示假阴性率较低，这促使人们省略腋窝淋巴结清扫术（ALND）。在关于反应引导下腋窝治疗的研究中，有广泛淋巴结疾病的乳腺癌患者报告不足。在本研究中，我们展示了根据MARI方案治疗的腋窝淋巴结受累≥4个的乳腺癌患者的肿瘤学结局。
这项前瞻性单臂注册研究纳入了2014年7月至2021年12月期间在PST前经氟脱氧葡萄糖正电子发射断层扫描/计算机断层扫描（FDG-PET/CT）显示腋窝淋巴结受累≥4个、有广泛淋巴结疾病的乳腺癌患者。PST后，切除标记（MARI）淋巴结。MARI淋巴结病理完全缓解（pCR，ypN0）的患者接受局部区域放射治疗（RT）。MARI淋巴结有残留疾病（ypN+）的患者先进行ALND，然后进行RT。主要终点是腋窝复发率。次要终点是无侵袭性疾病生存期（DFS）和总生存期（OS）。
总共登记了218例患者，其中39%的患者也有腋窝外淋巴结疾病。中位（四分位间距）年龄为50（42-57）岁。PST后，47%的患者（103/218）为ypN0，而53%的患者（115/218）为ypN+。中位随访44（26-62）个月后，ypN0组的腋窝复发率为2.9%（n = 3），ypN+组为3.5%（n = 4）。ypN0患者的五年无侵袭性DFS和OS分别为89%（95%置信区间83%-96%）和95%（95%置信区间91%-99%）。
对于有广泛淋巴结受累且MARI淋巴结达到pCR的乳腺癌患者，PST后省略ALND与优异的五年肿瘤学结局相关。
