Prediction of the pathological subtypes by intraoperative frozen section for patients with cT1N0M0 invasive lung adenocarcinoma (ECTOP-1015): a prospective multicenter study.

Zichen Fu,Zichen Fu,Zichen Fu,Zichen Fu,Zichen Fu,Zichen Fu,Zichen Fu,Zichen Fu,Zichen Fu,Qiang Zheng,Qiang Zheng,Yang Zhang,Fangqiu Fu,Junjie Ma,Chaoqiang Deng,Haiquan Chen,Yang Zhang,Yang Zhang,Hang Cao,Chaoqiang Deng,Chaoqiang Deng,Haiquan Chen,Haiquan Chen,Haiquan Chen,Chaoqiang Deng,Haiquan Chen,Haiquan Chen,Fangqiu Fu,Yang Zhang,Yan Jin,Yang Zhang,Xuxia Shen,Yan Jin,Fangqiu Fu,Qiang Zheng,Yang Zhang,Weihua Wang,Lei Zhang,Yang Zhang,Yang Zhang,Yongguo Yang,Hang Cao,Hang Cao,Yan Jin,Qiang Zheng,Chunyan Yuan,Hang Cao,Senzhong Zheng,Fangqiu Fu,Hang Cao,Haiquan Chen,Haiquan Chen,Xuxia Shen,Hang Cao,Shuying Zuo,Fangqiu Fu,Hang Cao,Chaoqiang Deng,Yan Jin,Fangqiu Fu,Chaoqiang Deng,Chaoqiang Deng,Qingli Gao,Yang Zhang,Fangqiu Fu,Xuxia Shen,Haiquan Chen,Shuqing You,Chaoqiang Deng,Guangli Su,Xuxia Shen,Yuan Li,Qingping Song,Chaoqiang Deng,Yuan Li,Bing Qian,Fangqiu Fu,Yuan Li,Hang Cao,Fangqiu Fu,Hang Cao,Yuan Li

doi:10.1097/js9.0000000000001667

Abstract

This study aims to assess the diagnostic accuracy of the intraoperative frozen section (FS) in determining the pathological subtypes among patients diagnosed with cT1N0M0 invasive lung adenocarcinoma. This was a prospective, multicenter (seven centers in China) clinical trial of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1015). Patients with cT1N0M0 invasive lung adenocarcinoma were enrolled in the study. Pathological images obtained from FS and final pathology (FP) were reviewed by at least two pathologists. The primary endpoint was the concordance between FS and FP diagnoses. The interobserver agreement for identifying pathological subtypes on FS was evaluated among three pathologists. A total of 935 patients were enrolled. The best sensitivity of diagnosing the predominant subtype was 78.2% in the evaluation of the acinar pattern. The presence of an acinar pattern diagnosed by FS was an independent factor for the concordance between FS and FP ( P =0.007, 95% confidence interval: 2.332-4.736). Patients with tumor size >2cm measured by pathology showed a better concordance rate for the predominant subtype (81.6% vs. 74.6%, P =0.023). The presence of radiological ground glass opacity component did not affect the diagnosis accuracy of FS for the predominant subtype (concordance rate: 76.4% vs. 75.2%, P =0.687). Patients with ground glass opacity component showed better accuracy of the identification in the presence of lepidic pattern-predominant adenocarcinoma (82.1% vs. 71.0%, P =0.026). Substantial agreement between the FS diagnosis from three pathologists for the predominant pathological pattern was revealed with κ=0.846. This is the largest prospective trial evaluating FS diagnosing pathological subtype in cT1N0M0 invasive lung adenocarcinoma. A favorable concordance in the assessment of the pathological subtypes between FS and FP was observed, indicating the feasibility of utilizing accurate intraoperative pathological diagnoses from FS in guiding surgical strategies. A combination of radiology could improve the precision of FS.

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