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KLASS-02随机临床试验中局部进展期胃癌术前临床分期的准确性

Accuracy of preoperative clinical staging for locally advanced gastric cancer in KLASS-02 randomized clinical trial.

作者信息

Kim Dong Jin, Hyung Woo Jin, Park Young-Kyu, Lee Hyuk-Joon, An Ji Yeong, Kim Hyoung-Il, Kim Hyung-Ho, Ryu Seung Wan, Hur Hoon, Kim Min-Chan, Kong Seong-Ho, Kim Jin-Jo, Park Do Joong, Ryu Keun Won, Kim Young Woo, Kim Jong Won, Lee Joo-Ho, Yang Han-Kwang, Han Sang-Uk, Kim Wook

机构信息

Department of Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.

Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea.

出版信息

Front Surg. 2022 Sep 23;9:1001245. doi: 10.3389/fsurg.2022.1001245. eCollection 2022.

DOI:10.3389/fsurg.2022.1001245
PMID:36211302
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9537949/
Abstract

PURPOSE

The discrepancy between preoperative and final pathological staging has been a long-standing challenge for the application of clinical trials or appropriate treatment options. This study aimed to demonstrate the accuracy of preoperative staging of locally advanced gastric cancer using data from a large-scale randomized clinical trial.

MATERIALS AND METHODS

Of the 1050 patients enrolled in the clinical trial, 26 were excluded due to withdrawal of consent ( = 20) or non-surgery (= 6). The clinical and pathological staging was compared. Risk factor analysis for underestimation was performed using univariate and multivariate analyses.

RESULTS

Regarding T staging by computed tomography, accuracy rates were 74.48, 61.62, 58.56, and 85.16% for T1, T2, T3 and T4a, respectively. Multivariate analysis for underestimation of T staging revealed that younger age, ulcerative gross type, circular location, larger tumor size, and undifferentiated histology were independent risk factors. Regarding nodal status estimation, 54.9% of patients with clinical N0 disease were pathologic N0, and 36.4% of patients were revealed to have pathologic N0 among clinical node-positive patients. The percentage of metastasis involvement at the D1, D1+, and D2 lymph node stations significantly increased with the advanced clinical N stage. Among all patients, 29 (2.8%), including 26 with peritoneal seeding, exhibited distant metastases.

CONCLUSIONS

Estimating the exact pathologic staging remains challenging. A thorough evaluation is mandatory before treatment selection or trial enrollment. Moreover, we need to set a sufficient case number when we design the clinical trial considering the stage migration.

摘要

目的

术前分期与最终病理分期之间的差异一直是临床试验应用或选择合适治疗方案的长期挑战。本研究旨在利用大规模随机临床试验的数据,证明局部进展期胃癌术前分期的准确性。

材料与方法

在纳入临床试验的1050例患者中,26例因撤回同意(n = 20)或未接受手术(n = 6)而被排除。比较临床分期和病理分期。采用单因素和多因素分析对分期低估的危险因素进行分析。

结果

关于计算机断层扫描的T分期,T1、T2、T3和T4a期的准确率分别为74.48%、61.62%、58.56%和85.16%。T分期低估的多因素分析显示,年龄较小、溃疡型大体类型、环形位置、肿瘤较大和未分化组织学是独立危险因素。关于淋巴结状态评估,临床N0期患者中54.9%为病理N0,临床淋巴结阳性患者中36.4%为病理N0。随着临床N分期的进展,D1、D1+和D2淋巴结站的转移累及百分比显著增加。在所有患者中,29例(2.8%)出现远处转移,其中26例有腹膜种植。

结论

准确估计病理分期仍然具有挑战性。在选择治疗方案或纳入试验之前,必须进行全面评估。此外,在设计考虑分期迁移的临床试验时,我们需要设定足够的病例数。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a9/9537949/d0df36363819/fsurg-09-1001245-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a9/9537949/78d3fe8e6e79/fsurg-09-1001245-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a9/9537949/c54083fa7b24/fsurg-09-1001245-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a9/9537949/d0df36363819/fsurg-09-1001245-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a9/9537949/78d3fe8e6e79/fsurg-09-1001245-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a9/9537949/c54083fa7b24/fsurg-09-1001245-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a9/9537949/d0df36363819/fsurg-09-1001245-g003.jpg

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