新辅助化疗后残留孤立肿瘤细胞患者（ypN0i+）的淋巴结负荷与肿瘤学结局：OPBC-05/ICARO研究
Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study.
作者信息
Montagna Giacomo, Laws Alison, Ferrucci Massimo, Mrdutt Mary M, Sun Susie X, Bademler Suleyman, Balbaloglu Hakan, Balint-Lahat Nora, Banys-Paluchowski Maggie, Barrio Andrea V, Benson John, Bese Nuran, Boughey Judy C, Boyle Marissa K, Diego Emilia J, Eden Claire, Eller Ruth, Goldschmidt Maite, Hlavin Callie, Heidinger Martin, Jelinska Justyna, Karadeniz Cakmak Güldeniz, Kesmodel Susan B, King Tari A, Kuerer Henry M, Loesch Julie, Milardi Francesco, Murawa Dawid, Moo Tracy-Ann, Menes Tehillah S, Passeri Daniele, Pastoriza Jessica M, Perhavec Andraz, Pislar Nina, Polidorio Natália, Rami Avina, Ryu Jai Min, Schulz Alexandra, Sevilimedu Varadan, Ugurlu M Umit, Uras Cihan, van Hemert Annemiek, Wong Stephanie M, Yoo Tae-Kyung Robyn, Zhang Jennifer Q, Karanlik Hasan, Cabioğlu Neslihan, Peeters Marie-Jeanne Vrancken, Morrow Monica, Weber Walter P
机构信息
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA.
出版信息
J Clin Oncol. 2025 Mar;43(7):810-820. doi: 10.1200/JCO.24.01052. Epub 2024 Nov 7.
PURPOSE
The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i+) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i+ treated with and without ALND.
METHODS
The Oncoplastic Breast Consortium-05/ICARO cohort study (ClinicalTrials.gov identifier: NCT06464341) retrospectively analyzed data from patients with stage I to III breast cancer with ITCs in SLNs after NAC from 62 centers in 18 countries. The primary end point was the 3-year rate of any axillary recurrence. The rate of any invasive recurrence was the secondary end point.
RESULTS
In total, 583 patients were included, of whom 182 (31%) had completion ALND and 401 (69%) did not. The median age was 48 years. Most patients (74%) were clinically node-positive at diagnosis and 41% had hormone receptor-positive/human epidermal growth factor receptor 2-negative tumors. The mean number of SLNs with ITCs was 1.2. Patients treated with ALND were more likely to present with cN2/3 disease (17% 7%, < .001), have ITCs detected on frozen section (62% 8%, < .001), have lymphovascular invasion (38% 24%, < .001), and receive adjuvant chest wall (89% 78%, = .024) and nodal radiation (82% 75%, = .038). Additional positive nodes were found at ALND in 30% of patients, but only 5% had macrometastases. The 3-year rates of any axillary and any invasive recurrence were 2% (95% CI, 0.95 to 3.6) and 11% (95% CI, 8 to 14), respectively, with no statistical difference by type of axillary surgery.
CONCLUSION
The nodal burden in patients with ypN0(i+) was low, and axillary recurrence after ALND omission was rare in patients selected for this approach. These results do not support routine ALND in all patients with ypN0(i+).
目的
新辅助化疗（NAC）后前哨淋巴结（SLN）中存在残留孤立肿瘤细胞（ITC）的患者（ypN0i+）的淋巴结负荷尚不清楚，腋窝处理也未标准化。我们调查了接受腋窝淋巴结清扫（ALND）和未接受ALND的ypN0i+患者在腋窝淋巴结清扫时额外阳性淋巴结（LN）的发生率及肿瘤学结局。
方法
肿瘤整形乳腺联盟-05/ICARO队列研究（ClinicalTrials.gov标识符：NCT06464341）回顾性分析了来自18个国家62个中心的I至III期乳腺癌患者在NAC后SLN中存在ITC的数据。主要终点是3年腋窝复发率。任何侵袭性复发率是次要终点。
结果
总共纳入583例患者，其中182例（31%）完成了ALND，401例（69%）未完成。中位年龄为48岁。大多数患者（74%）在诊断时临床淋巴结阳性，41%患有激素受体阳性/人表皮生长因子受体2阴性肿瘤。存在ITC的SLN的平均数量为1.2个。接受ALND治疗的患者更有可能表现为cN2/3疾病（17%对7%，P<.001），在冰冻切片上检测到ITC（62%对8%，P<.001），存在淋巴管浸润（38%对24%，P<.001），并接受辅助胸壁放疗（89%对78%，P =.024）和淋巴结放疗（82%对75%，P =.038）。30%的患者在ALND时发现额外的阳性淋巴结，但只有5%有大转移灶。任何腋窝和任何侵袭性复发的3年发生率分别为2%（95%CI，0.95至3.6）和11%（95%CI，8至14），腋窝手术类型之间无统计学差异。
结论
ypN0（i+）患者的淋巴结负荷较低，在选择该方法的患者中，省略ALND后腋窝复发很少见。这些结果不支持对所有ypN0（i+）患者进行常规ALND。
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