{"title":"A retrospective multi-center cohort study investigating safety of sentinel lymph node biopsy for axillary staging in clinical T3-4c breast cancer.","authors":"Sayaka Kuba, Yasuaki Sagara, Hiroshi Yano, Shigeto Maeda, Takehiko Sakai, Yasuyuki Kojima, Masaya Hattori, Sota Asaga, Eriko Tokunaga, Tadahiko Shien, Hiroko Bando, Keisei Anan, Nobutaka Iwakuma, Shigeki Minami, Miki Yamaguchi, Michiko Harao, Masahiro Oikawa, Takafumi Sangai, Makoto Ishitobi, Takahiro Nakayama, Tetsu Hayashida, Manami Tada, Kentaro Tamaki, Goro Kutomi, Mai Tomiguchi, Narumi Harada-Shoji, Kaname Kurashita, Kaori Terata, Kosho Yamanouchi, Makoto Kubo, Chika Yumura, Yoko Takahashi, Shigeru Imoto, Shinji Ohno, Naoki Hayashi","doi":"10.1007/s12282-025-01749-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Sentinel lymph node biopsy (SLNB) has become a standard procedure for patients with breast cancer (BC) without clinically evident axillary metastasis. However, its role in cT3-4cN0 BC remains underexplored, leading to uncertainty regarding its safety.</p><p><strong>Methods: </strong>This retrospective, multicenter observational study included patients with cT3-4cN0M0 BC who underwent radical surgery between 2006 and 2016. Patients were divided into an SLNB group, which included those who underwent SLNB exclusively and ALND after SLNB, and an ALND group, which included those who underwent ALND exclusively. Inverse probability treatment weighting was applied to balance the patient characteristics, with recurrence-free survival (RFS) as the primary endpoint.</p><p><strong>Results: </strong>The study included 930 patients: 716 in the SLNB group and 214 in the ALND group. The ALND group had a higher proportion of patients diagnosed earlier, more T4 tumors, and more frequent use of neoadjuvant chemotherapy. During a median follow-up period of 89 months, 176 RFS events and 51 loco-regional recurrence events occurred. After adjusting for confounding factors, no significant difference was found in 10-year RFS between the groups (74.2% vs. 79.2%). Adjusted hazard ratios for RFS did not differ between the groups, even when stratified by tumor stage (cT3, cT4) or neoadjuvant chemotherapy. No significant differences were observed between the SLNB and ALND groups in loco-regional recurrence rate (LRR), with 10-year LRR rates of 93.1% and 90.8%, respectively.</p><p><strong>Conclusions: </strong>SLNB was a safe axillary staging method for patients with cT3-4cN0M0 BC and does not impact RFS or LRR negatively when compared with ALND.</p>","PeriodicalId":520574,"journal":{"name":"Breast cancer (Tokyo, Japan)","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast cancer (Tokyo, Japan)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12282-025-01749-9","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract
Background: Sentinel lymph node biopsy (SLNB) has become a standard procedure for patients with breast cancer (BC) without clinically evident axillary metastasis. However, its role in cT3-4cN0 BC remains underexplored, leading to uncertainty regarding its safety.
Methods: This retrospective, multicenter observational study included patients with cT3-4cN0M0 BC who underwent radical surgery between 2006 and 2016. Patients were divided into an SLNB group, which included those who underwent SLNB exclusively and ALND after SLNB, and an ALND group, which included those who underwent ALND exclusively. Inverse probability treatment weighting was applied to balance the patient characteristics, with recurrence-free survival (RFS) as the primary endpoint.
Results: The study included 930 patients: 716 in the SLNB group and 214 in the ALND group. The ALND group had a higher proportion of patients diagnosed earlier, more T4 tumors, and more frequent use of neoadjuvant chemotherapy. During a median follow-up period of 89 months, 176 RFS events and 51 loco-regional recurrence events occurred. After adjusting for confounding factors, no significant difference was found in 10-year RFS between the groups (74.2% vs. 79.2%). Adjusted hazard ratios for RFS did not differ between the groups, even when stratified by tumor stage (cT3, cT4) or neoadjuvant chemotherapy. No significant differences were observed between the SLNB and ALND groups in loco-regional recurrence rate (LRR), with 10-year LRR rates of 93.1% and 90.8%, respectively.
Conclusions: SLNB was a safe axillary staging method for patients with cT3-4cN0M0 BC and does not impact RFS or LRR negatively when compared with ALND.
背景：前哨淋巴结活检（SLNB）已成为无临床明显腋窝转移的乳腺癌（BC）患者的标准手术。然而，其在cT3-4cN0 BC中的作用仍未被充分探索，导致其安全性的不确定性。方法：这项回顾性、多中心观察性研究纳入了2006年至2016年间接受根治性手术的cT3-4cN0M0型BC患者。患者被分为SLNB组和ALND组，前者包括单纯接受SLNB和SLNB后再进行ALND的患者，后者包括单纯接受ALND的患者。以无复发生存期（RFS）为主要终点，应用逆概率治疗加权来平衡患者特征。结果：共纳入930例患者，其中SLNB组716例，ALND组214例。ALND组患者早期诊断比例较高，T4肿瘤较多，新辅助化疗使用频率较高。在中位随访89个月期间，发生了176例RFS事件和51例局部区域复发事件。校正混杂因素后，两组10年RFS无显著差异（74.2% vs. 79.2%）。即使按肿瘤分期（cT3、cT4）或新辅助化疗分层，各组间RFS的校正风险比也没有差异。SLNB组和ALND组局部区域复发率（LRR）无显著差异，10年LRR分别为93.1%和90.8%。结论：对于cT3-4cN0M0型BC患者，SLNB是一种安全的腋窝分期方法，与ALND相比，SLNB不会对RFS或LRR产生负面影响。
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