Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study.

IF 42.1 1区医学 Q1 ONCOLOGY Journal of Clinical Oncology Pub Date : 2024-11-07 DOI:10.1200/JCO.24.01052

Giacomo Montagna, Alison Laws, Massimo Ferrucci, Mary M Mrdutt, Susie X Sun, Suleyman Bademler, Hakan Balbaloglu, Nora Balint-Lahat, Maggie Banys-Paluchowski, Andrea V Barrio, John Benson, Nuran Bese, Judy C Boughey, Marissa K Boyle, Emilia J Diego, Claire Eden, Ruth Eller, Maite Goldschmidt, Callie Hlavin, Martin Heidinger, Justyna Jelinska, Güldeniz Karadeniz Cakmak, Susan B Kesmodel, Tari A King, Henry M Kuerer, Julie Loesch, Francesco Milardi, Dawid Murawa, Tracy-Ann Moo, Tehillah S Menes, Daniele Passeri, Jessica M Pastoriza, Andraz Perhavec, Nina Pislar, Natália Polidorio, Avina Rami, Jai Min Ryu, Alexandra Schulz, Varadan Sevilimedu, M Umit Ugurlu, Cihan Uras, Annemiek van Hemert, Stephanie M Wong, Tae-Kyung Robyn Yoo, Jennifer Q Zhang, Hasan Karanlik, Neslihan Cabioğlu, Marie-Jeanne Vrancken Peeters, Monica Morrow, Walter P Weber

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Abstract

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% v 7%, P < .001), have ITCs detected on frozen section (62% v 8%, P < .001), have lymphovascular invasion (38% v 24%, P < .001), and receive adjuvant chest wall (89% v 78%, P = .024) and nodal radiation (82% v 75%, P = .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+).

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新辅助化疗后残留孤立肿瘤细胞（ypN0i+）患者的结节负荷和肿瘤学预后：OPBC-05/ICARO 研究。

目的：新辅助化疗（NAC）后前哨淋巴结（SLN）残留孤立肿瘤细胞（ITC）（ypN0i+）患者的结节负荷尚不清楚，腋窝管理也未标准化。我们调查了腋窝淋巴结清扫（ALND）时额外淋巴结（LNs）阳性率以及接受和未接受ALND治疗的ypN0i+患者的肿瘤预后：乳腺肿瘤整形联盟-05/ICARO队列研究（ClinicalTrials.gov标识符：NCT06464341）回顾性分析了18个国家62个中心的I期至III期乳腺癌患者的数据，这些患者在接受NAC治疗后，SLN中出现了ITC。主要终点是3年腋窝复发率。任何浸润性复发率是次要终点：共纳入 583 例患者，其中 182 例（31%）完成了 ALND，401 例（69%）未完成 ALND。中位年龄为 48 岁。大多数患者（74%）确诊时临床结节阳性，41%的患者激素受体阳性/人表皮生长因子受体2阴性。带有ITC的SLN平均数量为1.2个。接受 ALND 治疗的患者更有可能出现 cN2/3 病变（17% 对 7%，P < .001）、在冰冻切片上检测到 ITC（62% 对 8%，P < .001）、淋巴管受侵（38% 对 24%，P < .001），并接受胸壁辅助治疗（89% 对 78%，P = .024）和结节放射治疗（82% 对 75%，P = .038）。30%的患者在ALND时发现了额外的阳性结节，但只有5%的患者有大转移灶。任何腋窝和任何浸润性复发的3年率分别为2%（95% CI，0.95至3.6）和11%（95% CI，8至14），腋窝手术类型无统计学差异：结论：ypN0(i+)患者的结节负荷较低，在选择这种方法的患者中，省略ALND后腋窝复发的情况很少见。这些结果并不支持对所有ypN0(i+)患者进行常规ALND。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Oncology 医学-肿瘤学

CiteScore

41.20

自引率

2.20%

发文量

8215

审稿时长

2 months

期刊介绍： The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.