Comparison of molecular analysis and touch imprint cytology for the intraoperative evaluation of sentinel lymph nodes in primary breast cancer: Results of the China Breast Cancer Clinical Study Group (CBCSG) 001c trial
Comparison of molecular analysis and touch imprint cytology for the intraoperative evaluation of sentinel lymph nodes in primary breast cancer: Results of the China Breast Cancer Clinical Study Group (CBCSG) 001c trial
复制标题
DOI：
10.1016/j.ejso.2013.02.005
复制
发表时间：
2013-05-01
期刊：
影响因子：
3.8
通讯作者：
Wu, J.
中科院分区：
文献类型：
--
作者：
Chen, J. -J.;Chen, J. -Y.;Wu, J.
背景资料：为了验证一步核酸扩增（OSNA）乳腺癌系统在中国人群早期乳腺癌患者术中检测前哨淋巴结（SLN）转移的临床价值，进行了一项前瞻性多中心试验，即中国乳腺癌临床研究组（CBCSG）-001c试验。本研究旨在前瞻性地比较OSNA和接触印片细胞学（TIC）的性能。通过连续切片对组织块的交替切片进行OSNA分析或术后组织病理学评价。TIC进行每个组织块的每个样本表面，并由外科医生使用，以确定是否执行立即ALND.Results：共552例合格的分析。与TIC的敏感性、特异性和总体准确性相比，OSNA的敏感性、特异性和总体准确性分别为87.8%、89.6%和88.4%，TIC的敏感性、特异性和总体准确性分别为81.3%、96.9%和92.0%。在每个淋巴结的基础上，OSNA比TIC检测到更多的微转移相关淋巴结（52.8% vs. 25.0%; p = 0.029）。组织分配偏倚（TAB）是导致结果不一致的主要原因。TIC的性能差异显着的机构之间，而OSNA的性能是stabilized.Conclusions：OSNA和TIC可以作为合格的SLN术中评估。对于缺乏经验丰富的细胞病理学家支持的机构，OSNA可以作为术中评估的首选。此外，OSNA可作为组织病理学评估的补充。然而，本研究的结果并不支持常规应用OSNA在整个前哨淋巴结的病理连续切片的地方。(C)2013爱思唯尔有限公司保留所有权利。
Background: To validate the clinical value of the One-Step Nucleic Acid Amplification (OSNA) Breast Cancer System for the intraoperative detection of sentinel lymph node (SLN) metastases in early-stage breast cancer patients in a Chinese population, a prospective, multicenter trial, the China Breast Cancer Clinical Study Group (CBCSG)-001c trial, was conducted. The present study focused on the prospective comparison of the performance between OSNA and touch imprint cytology (TIC).Methods: The retrieved SLNs were divided into sections. Alternate slices from the tissue blocks were subjected either to OSNA analysis or to postoperative histopathology evaluation through serial sectioning. TIC was performed on every sample surface of each tissue block and was used by the surgeon to determine whether to perform an immediate ALND.Results: A total of 552 patients qualified for the analysis. The sensitivity, specificity, and overall accuracy of OSNA were 87.8%, 89.6%, and 88.4%, respectively, on a per-patient basis compared with those of TIC, which were 81.3%, 96.9%, and 92.0%, respectively. OSNA detected more micrometastasis-involved nodes than TIC (52.8% vs. 25.0%; p = 0.029) on a per-node basis. Tissue allocation bias (TAB) was the main cause of discordant results. The performance of TIC varied significantly among the institutes, while the performance of OSNA was steady.Conclusions: Both OSNA and TIC can serve as qualified intraoperative assessments of SLNs. For institutes lacking the support of experienced cytopathologists, OSNA can be the first choice for the intraoperative assessment. In addition, OSNA can be applied as a complement to histopathology assessment. However, the results of the present study do not support the routine application of OSNA in the entire SLNs in place of pathology with serial sectioning. (C) 2013 Elsevier Ltd. All rights reserved.