Houvenaeghel G, Boher J M, Reyal F, Cohen M, Garbay J R, Classe J M, Rouzier R, Giard S, Faure C, Charitansky H, Tunon de Lara C, Daraï E, Hudry D, Azuar P, Gimbergues P, Villet R, Sfumato P, Lambaudie E
Institut Paoli Calmettes and CRCM, 232 Bd Ste Marguerite, Marseille, France; Aix Marseille Université, France.
Department of Biostatistics and Methodology, Institut Paoli Calmettes, 13009, France; Aix-Marseille University, Unité Mixte de Recherche S912, Institut de Recherche pour le Développement, 13385, Marseille, France.
Eur J Cancer. 2016 Nov;67:106-118. doi: 10.1016/j.ejca.2016.08.003. Epub 2016 Sep 16.
Omission of completion axillary lymph node dissection (ALND) is a standard practice in patients with breast cancer (BC) and negative sentinel nodes (SNs) but has shown insufficient evidence to be recommended in those with SN invasion.
A retrospective analysis of a cohort of patients with BC and micrometastases (Mic) or isolated tumour cells (ITCs) in SN. Factors associated with ALND were identified, and patients with ALND were matched to patients without ALND. Overall survival (OS) and recurrence-free survival (RFS) were estimated in the overall population, in Mic and in ITC cohorts.
Among 2009 patients analysed, 1390 and 619 had Mic and ITC in SN, respectively. Factors significantly associated with ALND were SN status, histological type, age, number of SN harvested and absence of adjuvant chemotherapy. After a median follow-up of 60.4 months, ALND omission was independently associated with reduced OS (hazard ratio [HR] 2.41, 90 confidence interval [CI] 1.36-4.27, p = 0.0102), but not with increased RFS (HR 1.21, 90 CI 0.74-2.0, p = 0.52) in the overall population. In matched patients, the increased risk of death in case of ALND omission was found only in the Mic cohort (HR 2.88, 90 CI 1.46-5.69), not in the ITC cohort. The risk of recurrence was also significantly increased in the subgroup of matched Mic patients (HR 1.56, 90 CI 0.90-2.73).
A separate analysis of Mic and ITC groups, matched for the determinants of ALND, suggested that patients with Mic had increased recurrence rates and shorter OS when ALND was not performed. Our results are consistent with those of previous studies for patients with ITC but not for those with Mic. Randomised controlled clinical trials are still warranted to show with a high level of evidence if ALND can be safely omitted in patients with micrometastatic disease in SN.
对于乳腺癌（BC）且前哨淋巴结（SN）阴性的患者，省略腋窝淋巴结清扫术（ALND）是一种标准做法，但对于SN有转移的患者，尚无充分证据支持推荐省略该手术。
对一组BC患者且SN有微转移（Mic）或孤立肿瘤细胞（ITC）的患者进行回顾性分析。确定与ALND相关的因素，并将接受ALND的患者与未接受ALND的患者进行匹配。在总体人群、Mic人群和ITC人群中估计总生存期（OS）和无复发生存期（RFS）。
在分析的2009例患者中，分别有1390例和619例SN中有Mic和ITC。与ALND显著相关的因素包括SN状态、组织学类型、年龄、获取的SN数量和辅助化疗的缺失。中位随访60.4个月后，在总体人群中，省略ALND与OS降低独立相关（风险比[HR]2.41，90%置信区间[CI]1.36 - 4.27，p = 0.0102），但与RFS增加无关（HR 1.21，90% CI 0.74 - 2.0，p = 0.52）。在匹配患者中，仅在Mic人群中发现省略ALND时死亡风险增加（HR 2.88，90% CI 1.46 - 5.69），在ITC人群中未发现。在匹配的Mic患者亚组中复发风险也显著增加（HR 1.56，90% CI 0.90 - 2.73）。
对根据ALND决定因素进行匹配的Mic和ITC组进行单独分析表明，未进行ALND时，Mic患者的复发率增加且OS缩短。我们的结果与先前针对ITC患者的研究结果一致，但与Mic患者的研究结果不一致。仍有必要进行随机对照临床试验，以高水平证据表明对于SN有微转移疾病的患者是否可以安全省略ALND。
