Jean-Francois Boileau, Mark Basik, and Andre Lisbona, Montreal Jewish General Segal Cancer Centre, McGill University; Louis Gaboury, Isabelle Trop, Rami J. Younan, Erica Patocskai, and Andre Robidoux, Centre Hospitalier de l'Universite de Montreal; Lucas Sideris, Hopital Maisonneuve Rosemont, Universite de Montreal; Sarkis Meterissian and Atilla Omeroglu, McGill University Health Centre, Montreal; Brigitte Poirier and Louise Provencher, Hopital Saint-Sacrement, Universite Laval, Quebec City, Quebec; Claire M.B. Holloway and Frances C. Wright, Sunnybrook Odette Cancer Centre, University of Toronto; David R. McCready, University Health Network, University of Toronto, Toronto; Angel Arnaout, Ottawa Hospital, University of Ottawa, Ottawa; Muriel Brackstone, London Regional Cancer Program, University of Western Ontario, London, Ontario, Canada; and Stephen E. Karp, Lahey Hospital and Medical Center, Tufts University School of Medicine, Boston, MA.
J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.
PURPOSE: An increasing proportion of patients (> 30%) with node-positive breast cancer will obtain an axillary pathologic complete response after neoadjuvant chemotherapy (NAC). If sentinel node (SN) biopsy (SNB) is accurate in this setting, completion node dissection (CND) morbidity could be avoided. PATIENTS AND METHODS: In the prospective multicentric SN FNAC study, patients with biopsy-proven node-positive breast cancer (T0-3, N1-2) underwent both SNB and CND. Immunohistochemistry (IHC) use was mandatory, and SN metastases of any size, including isolated tumor cells (ypN0[i+], ≤ 0.2 mm), were considered positive. The optimal SNB identification rate (IR) ≥ 90% and false-negative rate (FNR) ≤ 10% were predetermined. RESULTS: From March 2009 to December 2012, 153 patients were accrued to the study. The SNB IR was 87.6% (127 of 145; 95% CI, 82.2% to 93.0%), and the FNR was 8.4% (seven of 83; 95% CI, 2.4% to 14.4%). If SN ypN0(i+)s had been considered negative, the FNR would have increased to 13.3% (11 of 83; 95% CI, 6.0% to 20.6%). There was no correlation between size of SN metastases and rate of positive non-SNs. Using this method, 30.3% of patients could potentially avoid CND. CONCLUSION: In biopsy-proven node-positive breast cancer after NAC, a low SNB FNR (8.4%) can be achieved with mandatory use of IHC. SN metastases of any size should be considered positive. The SNB IR was 87.6%, and in the presence of a technical failure, axillary node dissection should be performed. We recommend that SN evaluation with IHC be further evaluated before being included in future guidelines on the use of SNB after NAC in this setting.
目的：越来越多的淋巴结阳性乳腺癌患者（>30%）在新辅助化疗（NAC）后会获得腋窝病理完全缓解。如果前哨淋巴结（SN）活检（SNB）在这种情况下准确，那么可以避免完成淋巴结清扫术（CND）的发病率。
患者和方法：在这项前瞻性多中心 SN FNAC 研究中，经活检证实的淋巴结阳性乳腺癌（T0-3，N1-2）患者均接受 SNB 和 CND。必须使用免疫组织化学（IHC），并且包括任何大小的 SN 转移，包括孤立肿瘤细胞（ypN0[i+]，≤0.2mm），均被认为是阳性。预先确定了最佳 SNB 识别率（IR）≥90%和假阴性率（FNR）≤10%。
结果：从 2009 年 3 月至 2012 年 12 月，共有 153 名患者入组该研究。SNB 的 IR 为 87.6%（127/145；95%CI，82.2%至 93.0%），FNR 为 8.4%（7/83；95%CI，2.4%至 14.4%）。如果将 SN ypN0（i+）s 视为阴性，FNR 将增加至 13.3%（11/83；95%CI，6.0%至 20.6%）。SN 转移的大小与非 SN 阳性率之间无相关性。使用这种方法，30.3%的患者可能可以避免 CND。
结论：在 NAC 后的活检证实的淋巴结阳性乳腺癌中，通过强制性使用 IHC，可实现低 SNB FNR（8.4%）。任何大小的 SN 转移均应视为阳性。SNB 的 IR 为 87.6%，如果出现技术失败，应进行腋窝淋巴结清扫术。我们建议在该研究中进一步评估使用 IHC 进行 SN 评估后，再将其纳入 NAC 后 SNB 使用指南中。
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