前哨淋巴结阳性乳腺癌患者非前哨淋巴结转移的影响因素分析

目的 前哨淋巴结活检术(sentinel lymph nodes biopsy,SLNB)已经广泛应用于乳腺癌外科治疗,临床发现部分转移淋巴结仅局限于前哨淋巴结.本研究分析前哨淋巴结(sentinel lymph nodes,SLN)阳性乳腺癌患者非前哨淋巴结(non-sentinel lymph nodes,NSLN)转移的影响因素,从而避免不必要的腋窝淋巴结清除(axillary lymph node dissection,ALND).方法 回顾性分析聊城市人民医院乳腺外科2013-07-1-2015-06-30 SLNB阳性行ALND的77例女性乳腺癌患者临床病理资料,分析NSLN转移的影响因素.结果 在SIN清除个数≥4个的情况下,单因素分析发现阳性SLN≥2个(x2=10.109,P=0.01)以及LuminalB型患者(x2=6.442,P=0.02)发生NSLN转移的风险高.Logistic回归进行多因素分析发现,阳性SLN≥2个是影响NSLN转移的独立危险因素(OR=207.833,95％ CI为1.430～30 201.980,P=0.036).结论 阳性SLN数和分子亚型是影响NSLN转移的危险因素,阳性SLN≥2个是影响NSLN转移的独立危险因素.     

1枚前哨淋巴结阳性早期乳腺癌保腋窝的可行性分析

目的探讨1枚前哨淋巴结（sentinel lymph node,SLN）阳性的早期乳腺癌患者保腋窝（omitting axillary dissection,OAD）的可行性。方法用美蓝作为示踪剂先行乳腺癌前哨淋巴结活检术（sentinel lymph node biopsy,SLNB）,根据快速冰冻病理结果分为SLN阴性组与1枚SLN阳性组,随后两组均行常规腋窝淋巴结清扫（axillary lymph node dissection,ALND）以解剖出非前哨淋巴结（non—sentinellymphnode,NSLN）,比较两组间NSLN的阳性率。结果SLN阴性组30例,1例NSLN阳性,阳性率为3．3％,准确性为96．7％（29／30）;1枚SLN阳性组30例,仅3例NSLN阳性,阳性率为10．0％;两组阳性率差异无统计学意义（X^2=1．071,P=0．612）。全组随访1～48个月,均无区域淋巴结复发。结论1枚SLN阳性的早期乳腺癌患者可考虑OAD。     

ACOSOG Z0011试验标准用于中国前哨淋巴结阳性乳腺癌患者以避免腋窝淋巴结清扫的可行性研究

背景与目的:美国外科医师学会肿瘤学组(American College of Surgeons Oncology Group,ACOSOG)Z0011试验的结果改变了乳腺癌前哨淋巴结(sentinel lymph node,SLN)阳性患者的传统治疗模式。本研究的目的在于探讨ACOSOG Z0011试验标准用于中国前哨淋巴结阳性乳腺癌患者以避免腋窝淋巴结清扫(axillary lymph node dissection,ALND)的可行性。方法:连续收集194例SLN阳性的乳腺癌患者,根据Z0011的标准分为可以只做前哨淋巴结活检(sentinel lymph node biopsy,SLNB)组和仍需做ALND组。将SLNB组患者的临床病理学特征与Z0011试验标准的原始入组人群进行比较,再将SLNB组与ALND组患者的临床病理学特征进行比较。结果:194例患者中有77例符合Z0011标准可以只做SLNB,117例患者不符合Z0011标准,需要做ALND;SLNB组患者与Z0011标准原始入组人群比较,T1期肿瘤、ER阳性肿瘤、淋巴结转移数目少的肿瘤、非前哨淋巴结(non-sentinel lymph node,NSLN)阴性的肿瘤都显著多于Z0011标准原始人群,差异有统计学意义(P<0.05)。本研究ALND组患者与SLNB组患者比较,T2、T3期肿瘤较多,但差异无统计学意义(P>0.05)。ALND组腋窝淋巴结转移数目多的患者比例要明显多于SLNB组,NSLN阳性患者比例也高于SLNB组,差异均有统计学意义(P<0.05)。结论:将Z0011试验标准用于SLN阳性乳腺癌患者,能够筛选出较Z0011标准研究中预后更好、更为低危的患者,使得该部分患者可以更为安全的只接受SLNB。     

前哨淋巴结活检在早期乳腺癌患者腋窝管理中的研究进展

传统的观点认为腋窝淋巴结清扫(axillary lymph node dissection,ALND)是前哨淋巴结(sentinellymph node,SLN)阳性乳腺癌患者的标准治疗方法,而ALND容易引起上肢水肿、功能障碍等术后并发症,影响患者生活质量.近几年研究显示,对于SLN阳性的早期乳腺癌,并非所有患者都需...     

乳腺癌SLN阳性与残余腋淋巴结阳性的预测因素

目的明确前哨淋巴结(SLN)阳性乳腺癌中不同的临床病理特点,并确定非SLN(NSLN)发生转移的预测因素。方法回顾分析726例成功确定了SLN的0~Ⅱ期乳腺癌病例,SLN阳性的185例患者接受腋窝淋巴结清除(ALND)。根据NSLN有无转移,将该185例分为两组,残余腋窝淋巴结有转移组(NSLN )81例,残余腋窝淋巴结无转移组(NSLN-)104例。结果多变量分析显示,原发肿瘤较大(>2.0cm)、淋巴管浸润、阳性SLN较大(>2mm)、所获得的SLN全部阳性4项均与NSLN阳性相关。在4项因素均存在的病例中,73%(30/41)存在NSLN阳性。结论4项独立的预测因素与NSLN转移有关。     

腋窝前哨淋巴结阳性乳腺癌患者腋窝非前哨淋巴结转移风险预测

目的探讨腋窝前哨淋巴结(SLN)1～2枚阳性的乳腺癌患者, 腋窝非前哨淋巴结(nSLN)转移的危险因素, 预测nSLN转移风险。方法选择2002—2017年手术治疗的、SLN 1～2枚阳性的乳腺癌患者917例, 收集其临床病理资料。根据手术时间将患者分为建模组(497例)和验证组(420例)。以nSLN是否转移为因变量, 建立列线图模型, 并对模型的预测效果进行验证。结果 917例患者的nSLN转移率为27.4%。单因素分析显示, 病理分级、原发肿瘤脉管瘤栓、淋巴结包膜外受侵、SLN阳性数、SLN阴性数、SLN是否宏转移与乳腺癌患者腋窝nSLN转移有关(均P<0.05)。多因素Logistic回归分析显示, SLN阳性数、SLN阴性数和SLN是否宏转移为乳腺癌患者腋窝nSLN转移的独立影响因素(均P<0.05)。以有统计学意义的变量, 建立了列线图模型。建模组预测nSLN转移风险的受试者工作特征(ROC)曲线下面积为0.718, 验证组预测nSLN转移风险的ROC曲线下面积为0.742。结论利用6个危险因素建立的nSLN转移风险预测模型有较高的准确性, 可能有助于临床医师进...     

简化腋窝淋巴结清扫术在早期乳腺癌治疗中的应用

目的探讨简化腋窝淋巴结清扫术(axillary lymph node dissection,ALND)在乳腺癌手术中的应用及效果。方法分析2009年1月至2013年6月间行前哨淋巴结活检(sentinel lymph node biopsy,SLNB)327例乳腺癌患者的临床资料,行亚甲蓝染色法SLNB后根据前哨淋巴结(sentinel lymph node,SLN)冰冻病理结果,对SLN阳性者行规范的ALND,SLN阴性则行简化的ALND(只清扫LevelⅠ),比较两组在手术时间、术后住院时间、腋窝引流时间及术后并发症的差异。结果 327例患者中,314例成功进行了SLNB,119例SLN阳性者行标准的ALND,195例SLN阴性者行简化的ALND,11例SLN阴性患者出现LevelⅠ组织淋巴结转移;简化组手术时间、术后住院时间、腋窝引流时间明显缩短,术后腋窝积液、肌力减退、活动受限、疼痛、麻木、肿胀等并发症明显减少。术后随访3~60个月,患者无腋窝淋巴结复发及远处转移。结论蓝染法SLNB是乳腺癌患者腋窝淋巴结转移状态的重要检测技术,对SLN阴性行简化的ALND,可节省医疗资源、减少术后并发症。     

不同分子分型1～2枚前哨淋巴结阳性乳腺癌免行腋窝淋巴结清扫的多因素分析

目的探讨不同分子分型1～2枚前哨淋巴结（sentinel lymph nodes,SLNs）阳性乳腺癌免行腋窝淋巴结清扫（axillary lymph node dissection,ALND）的临床病理因素,并为临床精准化提供依据。方法回顾性分析2009年6月至2018年6月274例就诊于内蒙古医科大学附属医院和内蒙古医科大学附属人民医院经病理证实的乳腺癌患者的临床病理资料,采用单因素及Logistic多因素分析筛选1～2枚SLN阳性但非前哨淋巴结（nonsentinel lymph node,NSLN）转移率较低的患者,同时明确其与不同分子分型的关系。结果274例1～2枚SLN阳性乳腺癌患者中,NSLN转移率为36.9%（101/274）。HER-2阳性（HR阳性）患者NSLN转移率最高, 占55.3%（21/38）;三阴性乳腺癌（triple negative breast cancer,TNBC）患者中NSLN转移率最低,占18.5%（5/27）。Luminal B型（HER-2阴性）乳腺癌患者的NSLN转移率明显高于Luminal A型（P=0.010）和TNBC患者（P=0.011）;HER-2阳性（HR阳性）乳腺癌患者的NSLN转移率明显高于Luminal A型（P=0.002）和TNBC患者（P=0.003）。 Logistic多因素分析显示,SLN转移数目（OR=4.022, 95%CI为2.348～6.889,P<0.001）,SLN检测（OR=3.846, 95%CI为1.541～9.600,P=0.004）,组织学分级（P<0.001）和分子分型（P=0.004）是1～2枚SLN阳性乳腺癌NSLN转移的独立影响因素。结论Luminal B型（HER-2阴性）和HER-2阳性（HR阳性）患者的NSLN阳性率较高,SLN转移数目、SLN检测、组织学分级和分子分型是NSLN转移的独立影响因素。      

乳腺癌伴1～2枚前哨淋巴结转移腋窝外科处理的研究进展

摘 要：乳腺癌腋窝手术对确立临床分期、辅助治疗选择及预后判断均有重要价值。临床淋巴结阴性的乳腺癌,应用前哨淋巴结活检（SLNB）确定腋窝淋巴结分期已成为标准。对于前哨淋巴结（SLN）阴性的乳腺癌,腋窝淋巴结清扫（ALND）可以避免;而对于SLN阳性的乳腺癌,ALND仍是标准的腋窝处理方式。然而,在SLN阳性患者中进一步行ALND后发现,在仅1～2枚SLN阳性患者中,61.4%～64.5%非前哨淋巴结（nSLN）为阴性。已有大量的临床研究探索了特定条件下的1～2枚SLN阳性患者免除ALND的可行性与安全性。全文就乳腺癌伴1～2枚SLN转移腋窝外科处理的相关研究进行综述。     

女性乳腺癌患者前哨淋巴结和非前哨淋巴结转移危险因素研究

目的 分析前哨淋巴结(SLN)与非前哨淋巴结(NSLN)转移的危险因素,从而避免过度的腋窝淋巴清除治疗.方法 收集2015-09-01-2020-04-25新疆石河子大学医学院第一附属医院收治的422例患乳腺癌并行前哨淋巴结活检术(SLNB)患者的相关临床资料,部分SLN阳性患者行腋窝淋巴结清除术(ALND).采用病例...     

Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients

Several models have been developed to predict non-sentinel nodes (NSLN) metastasis in patients with a positive sentinel node (SLN) that incorporates a standard pathology examination of the SLN. It has been reported that total tumoral load (TTL) in the SLNs assessed by one-step nucleic acid amplification (OSNA) is a predictive factor for additional NSLN metastasis in the axillary lymph node dissection (ALND). The objective was to develop a nomogram that predicts patient´s risk of additional NSLN metastasis incorporating TTL in the SLNs assessed by OSNA. Six hundred and ninety-seven consecutive patients with positive SLN evaluation by OSNA and a completion ALND were recruited. Pathologic features of the primary tumor and SLN metastases, including TTL were collected. Multivariate logistic regression identified factors predictive of non-SLN metastasis. A nomogram was developed with these variables and validated in an external cohort. On multivariate logistic regression analysis, tumor size, number of affected SLN, Her2 overexpression, lymphovascular invasion, and TTL were each associated with the likelihood of additional NSLN metastasis (p < 0.05). The overall predictive accuracy of the nomogram, as measured by the AUC was 0.7552 (95 %CI 0.7159–0.7945). When applied to the external cohort the nomogram was accurate with an AUC = 0.678 (95 %CI 0.621–0.736). This novel nomogram that incorporates TTL assessed by OSNA performs well and may help clinicians to make decisions about ALND for individual patients. Moreover, the standardization of pathologic assessment by OSNA may help to achieve interinstitutional reproducibility among nomograms.     

A Breast Cancer Nomogram for Prediction of Non-Sentinel Node Metastasis - Validation of Fourteen Existing Models

Background: To avoid performing axillary lymph node dissection (ALND) for non-sentinel lymph node(SLN)-negative patients with-SLN positive axilla, nomograms for predicting the status have been developed inmany centers. We created a new nomogram predicting non-SLN metastasis in SLN-positive patients with invasivebreast cancer and evaluated 14 existing breast cancer models in our patient group. Materials and Methods:Two hundred and thirty seven invasive breast cancer patients with SLN metastases who underwent ALND wereincluded in the study. Based on independent predictive factors for non-SLN metastasis identified by logisticregression analysis, we developed a new nomogram. Receiver operating characteristics (ROC) curves for themodels were created and the areas under the curves (AUC) were computed. Results: In a multivariate analysis,tumor size, presence of lymphovascular invasion, extranodal extension of SLN, large size of metastatic SLN,the number of negative SLNs, and multifocality were found to be independent predictive factors for non-SLNmetastasis. The AUC was found to be 0.87, and calibration was good for the present Ondokuz Mayis nomogram.Among the 14 validated models, the MSKCC, Stanford, Turkish, MD Anderson, MOU (Masaryk), Ljubljana,and DEU models yielded excellent AUC values of > 0.80. Conclusions: We present a new model to predict thelikelihood of non-SLN metastasis. Each clinic should determine and use the most suitable nomogram or shouldcreate their own nomograms for the prediction of non- SLN metastasis.     

Sentinel lymph node analysis in breast cancer: contribution of one-step nucleic acid amplification (OSNA)

One-step nucleic acid amplification (OSNA, Sysmex, Kobe, Japan) offers an excellent opportunity for accurate exhaustive sentinel lymph node (SLN) examination in breast cancer patients. Calibrated with conventional postoperative histology, this molecular technique yields comparable results intraoperatively, expressed as micrometastasis, macrometastasis or no metastasis depending on the CK19 mRNA copy number amplified in SLN lysates. We applied OSNA to detect metastasis in 810 SLNs from 367 patients with early stage breast cancer. We compared the rate of OSNA-positive SLNs in patients with invasive breast cancer (< 2 cm) versus the rate observed in a historical cohort using conventional histological examination of SLNs. No significant difference was observed, the OSNA assay was positive in 24.4% of patients, compared with positive histology in 24.8% in the historical cohort if including patients with isolated tumour cell (ITC) and in 23.4% excluding them. Opportunities for optimised patient management using OSNA are discussed: intraoperative detection of OSNA-positive SLNs enables axillary lymph node dissection (ALND) during the same procedure; standard OSNA techniques enable the establishment of homogeneous groups based on examination of whole SLNs for valid comparisons between different centres.     

Ljubljana nomograms for predicting the likelihood of non-sentinel lymph node metastases in breast cancer patients with a positive sentinel lymph node

Several tools for predicting the likelihood of non-sentinel lymph node (non-SLN) involvement in SLN-positive breast cancer patients have been created so far. The aim of our study was to create and validate different nomograms for predicting the likelihood of non-SLN involvement that would be applicable in different institutions and that would also include the results of the preoperative US examination of the axilla. From January 2000 to January 2009, 534 breast cancer patients underwent axillary lymph node dissection (ALND) due to metastatic SLN at our institution. Using logistic regression results three nomograms differing in the inclusion of the results of intraoperative examination of SLN were created. The nomograms were validated using bootstrap methods. In all three nomograms, US examination of the axilla was a powerful independent variable. Other variables included (different in different nomograms) were tumor size, lymphovascular invasion, metastasis size in SLN, number of negative and number of positive SLNs. Mean absolute error and mean area under the ROC curve equals to 0.016 and 0.77 for the first, 0.023 and 0.75 for the second and 0.014 and 0.79 for the third nomogram. Three nomograms for predicting the likelihood of non-SLN metastases including the results of the preoperative US examination of the axilla were created at our institution. They differ in the inclusion of the results of intraoperative examination of SLNs and are thus applicable in different institutions. The validation results seem promising and omission of completion ALND might be considered in patients with the probability of having non-SLN metastases of 10% or less.     

Intraoperative Molecular Analysis of Total Tumor Load in Sentinel Lymph Node: A Predictor of Axillary Status in Early Breast Cancer

Background: Axillary lymph node dissection (ALND) remains the standard of care in breast cancer patients with positive sentinel lymph node (SLN). However, approximately 40–60% of patients with positive SLNs have not developed to non-SLN metastasis and ALND seems to be an overtreatment. The purpose of this study was to analyze predictors and define a specific cut-off of total tumor load (TTL) of CK19 that can be used as a predictive factor of non-SLN metastasis in early breast cancer patients. Materials and Methods: The records of 238 patients with cT1-3N0 breast cancer who had an intraoperative SLN evaluation performed through One-Step nucleic acid (OSNA) assay at Songklanagarind Hospital between 1 January 2015 and 31 December 2019 were examined. Univariate and Multivariate analysis was used to identify clinicopathologic features in SLN-positive patients that predict metastasis to non-SLNs. Finally, receiver operative characteristics (ROC) curves were used to choose an optimal TTL cut-off value. Results: Of a total of 110 patients who had a positive SLN, only 48 (43.64%) were found to have positive nodes in non-SLN. Multivariate analysis revealed that lymphovascular invasion, type of SLN metastasis and SLN TTL (copies/μL) were independent predictors of positive non-SLNs.  TTL cut-off value was 19,000 copies/μL, with an AUC of 0.838 with 72.7% sensitivity and 84.7% specificity to predict non-SLN metastasis. Conclusions: The likelihood of positive non-SLNs in patients who showed a positive SLN correlates with lymphovascular invasion, type of SLN metastasis and SLN TTL (copies/μL). Our result revealed that the patients with a SLN TTL ≥19,000 copies/µl continue to attract the recommendation to proceed with ALND. This cut-off value can then help clinicians to assess which patients would benefit from ALND.     

The MSKCC nomogram for prediction the likelihood of non-sentinel node involvement in a German breast cancer population

Objective To assess whether the Memorial Sloan Kettering Cancer Center (MSKCC) nomogram for prediction of NSLN metastasis is useful in a German breast cancer population and whether the characteristics of the breast tumor and the sentinel lymph node (SLN) are able to predict the likelihood of non-sentinel lymph node (NSLN) metastasis. Methods A total of 545 patients with primary breast cancer and SLN examination were evaluated. The MSKCC nomogram was applied to 98 patients with a positive SLN who subsequently had completion axillary lymph node dissection (ALND). Predictive accuracy was assessed by calculating the area under the receiver-operator characteristic (ROC) curve. The collective was evaluated by correlating the prevalence of NSLN and SLN metastasis to pathological features. Results The MSKCC nomogram achieved a ROC of 0.58 indicating a bad accuracy of the nomogram. Tumor size, histology, lymphovascular infiltration, multifocality, Her-2-neu positivity, and nuclear grade correlated with the probability of SLN metastasis. Histology and primary tumor localization correlated significantly with the probability of NSLN metastasis. Conclusions The MSKCC nomogram did not provide a reliable predictive model in our study population. However, the likelihood of SLN metastasis correlated with the presumed risk factors and no obvious differences between the MSKCC population and our population could be seen. In order to achieve interinstitutional reproducibility, standardization of surgical procedure and of the pathological assessment of the SLN is desirable.     

1个前哨淋巴结阳性乳腺癌患者的腋窝非前哨#br# 淋巴结转移情况及危险因素分析#br#

目的研究1个前哨淋巴结阳性的乳腺癌患者腋窝非前哨淋巴结（NSLN）转移情况及危险因素,为该类患者豁免腋窝淋巴结清扫（ALND）提供指导。方法选取2013年1月至2020年12月在哈尔滨医科大学附属肿瘤医院行前哨淋巴结活检（SLNB）证实仅有1个前哨淋巴结阳性且行ALND的乳腺癌患者465例,根据其腋窝NSLN转移情况,分为NSLN转移组104例,NSLN未转移组361例。比较两组的一般资料,采用二元Logistic回归分析腋窝NSLN转移的独立影响因素。结果465例仅1个前哨淋巴结转移的乳腺癌患者中,104例（224%）发生腋窝NSLN转移。其中,多个亚组患者的腋窝NSLN转移率<10%,如肿瘤T1a+b期的NSLN转移率仅91%、肿瘤T1期且前哨淋巴结数量＞5个的腋窝NSLN转移率仅70%等。单因素分析结果显示,NSLN转移组与NSLN未转移组前哨淋巴结数、肿瘤T分期差异有统计学意义（P<005）。前哨淋巴结2～5个、肿瘤分期为T2～T3期的患者更容易发生腋窝NSLN转移。多因素Logistic回归分析显示,肿瘤分期为T2～T3期、前哨淋巴结数≤5个是患者腋窝NSLN转移的独立危险因素。结论仅有1个前哨淋巴结转移的乳腺癌患者总体腋窝NSLN转移率为224%,肿瘤T分期和前哨淋巴结数为腋窝NSLN转移的影响因素,在对仅1个前哨淋巴结阳性的乳腺癌患者豁免ALND时应重点考虑。     

Routine clinical use of the one-step nucleic acid amplification assay for detection of sentinel lymph node metastases in breast cancer patients: results of a multicenter study in Japan

BACKGROUND:

The objective of this study was to confirm, by means of a multicenter study conducted in Japan, the reliability and usefulness of the one‐step nucleic acid amplification (OSNA) assay in routine clinical use for sentinel lymph node biopsy (SLNB) of breast cancer patients.

METHODS:

Patients with Tis‐T2N0M0 breast cancer who underwent SLNB before systemic chemotherapy comprised the study cohort. A whole sentinel lymph node (SLN) was examined intraoperatively with the OSNA assay except for a 1‐mm‐thick, central slice of the lymph node, which underwent pathologic examination after the operation. For patients who underwent axillary dissection, non‐SLNs were examined with routine pathologic examination.

RESULTS:

In total, 417 SLNBs from 413 patients were analyzed. SLN metastases were detected with greater sensitivity by the OSNA assay than by pathologic examination (22.5% vs 15.8%; P < .001), as expected from the difference in size of the specimens examined. Patients who had SLN metastases assessed with the OSNA assay proved to harbor non‐SLN metastases with an overall risk ratio of 33.7%. The risk of non‐SLN metastasis was significantly lower for patients who had positive SLNs assessed as OSNA+ than for those who had SLNs assessed as OSNA++ (17.6% vs 44%; P = .012).

CONCLUSIONS:

The OSNA assay can be used for routine clinical SLNB, and its assessment for volume of metastasis may be a powerful predictive factor for non‐SLN metastasis. Further studies with more patients are needed to confirm the usefulness of this assay for selection in the clinical setting of patients who do not need axillary dissection. Cancer 2012;3477–3483. © 2012 American Cancer Society.     

Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients

The purpose of this prospective multicenter study was to assess one-step nucleic acid amplification (OSNA) for intraoperative sentinel lymph node (SLN) metastasis detection in breast cancer patients, using final histology as the reference standard. OSNA results were also compared to intraoperative histology SLN evaluation and to standard clinicopathological risk markers. For this study, fresh SLNs were cut in four blocks, and alternate blocks were used for OSNA and histology. CK19 mRNA copy number was categorized as strongly positive, positive or negative. Positive histology was defined as presence of macrometastasis or micrometastasis. When discrepancies occurred, the entire SLNs were subjected to histological studies and the node lysates to additional molecular studies. Five hundred three SLN samples from 233 patients were studied. Mean time to evaluate two SLNs was 40 min. Sensitivity per patient was 91.4% (95% CI, 76.9-98.2%), specificity 93.3% (95% CI, 88.6-96.6%), positive likelihood ratio 13.7 and negative likelihood ratio 0.1. Sensitivity was 63.6% for frozen sections and 47.1% for touch imprint cytology. Both methods were 100% specific. Positive histology and positive OSNA were significantly associated with highest clinical stage, N1 status and vascular invasion; and OSNA results correlated with HER2/neu status and benefited patients with negative histology. These findings show that OSNA assay can allow detection of SLN metastasis in breast cancer patients intraoperatively with a good sensitivity, thus minimizing the need for second surgeries for axillary lymph node detection.     

Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients

Objective To assess the intraoperative positive sentinel lymph node (SLN) total tumor load (TTL, defined as the amount of CK19 mRNA copies [copies/μL] in all positive SLNs) obtained by one-step nucleic acid amplification (OSNA) and to determine whether it is predictive of non-SLNs involvement. Summary background data The OSNA assay (Sysmex Corporation, Kobe, Japan) is a new diagnostic technique that uses molecular biological techniques to analyze SLN that has been validated as an accurate method for detection of positive SLN. Although the American College of Surgeons Oncology Group Z0011 trial has defined a select cohort of patients in whom a completion axillary lymph node dissection (cALND) may be safely omitted, there are a still a number of patients where prediction of non-SLN metastasis may be helpful for cALND decision making. Multiple studies suggest that specific pathologic characteristics of the primary tumor and the SLN metastases are associated with an increased likelihood of additional positive non-SLN. Methods This is a retrospective multicentric cohort study of 697 patients with cT1-3N0 breast cancer, who had had intraoperative SLN evaluation by OSNA assay with a cALND. TTL is defined as the amount of CK19 mRNA copies number in all positives SLN (copies/μL). Results Univariate logistic regression showed that, in addition to TTL (p < 0.001), the number of affected SLNs (p < 0.001), tumor size (p < 0.001), HER2 status (p = 0.007), and lymphovascular invasion (LVI, p < 0.001) were predictive of ALND status. The multivariate logistic regression analysis showed that TTL is an independent predictor of metastatic non-SLNs, after adjusting for the tumor size, HER2 status, LVI and, in particular, the number of affected SLNs. Conclusions TTL by OSNA is a newly standardized and automated tool that predicts axillary node status better and independently of the number of affected SLNs and the type of surgery. This value can then help clinicians to personalize surgical treatment. Prospective studies will be carried out to determine the clinical impact of this variable in the management of patients.