Chong Yue, Zhou Haibin, Zhang Peng, Xue Li, Du Qiao, Chong Tie, Wang Zhenlong
Department of Urology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi Wu Road, Xin Cheng district, Xi'an, Shaanxi, 710004, China.
Department of Urology, First Affiliated Hospital of Xi'an Medical University, Xi'an, Shaanxi, 710077, China.
BMC Cancer. 2025 Mar 11;25(1):436. doi: 10.1186/s12885-025-13815-8.
The diagnostic criteria for cM0 (i+) stage proposed by American Joint Committee on Cancer (AJCC) in renal cell carcinoma (RCC) still remains unclear. The present study aimed to establish and validate the criteria of cM0 (i+) stage based on postoperative circulating tumor cells (CTCs) monitoring in patients with localized renal cell carcinoma (LRCC).
This study enrolled 204 patients with LRCC who received partial or radical nephrectomy from January 2015 to November 2021. Cases were randomly divided into test set and validation set. The correlation between clinicopathological features and CTCs counts were analyzed and prognostic variables were determined by Lasso regression. Receiver operating characteristic curve of the prognosis-related CTCs terms were plotted to determine their optimal cut-off value to establish the criteria of cM0 (i+) stage. Its clinical prognostic significance was explored by Kaplan-Meier analysis and Log-rank test. The above analysis was conducted by SPSS26.0 software and R Studio software. P < 0.05 was considered to be statistically significant.
A total of 204 patients were analyzed in this study.There were no significant differences in variables between the validation and test sets (P>0.05). Total CTCs, mesenchymal CTCs (MCTCs), and CTCs showing a progressive trend were selected as the diagnostic basis for the cM0 (i+) stage through correlation analysis and Lasso regression. The cM0 (i+) stage identified patients meeting the following criteria simultaneously: (1) total CTCs ≥ 6; (2) MCTCs ≥ 1; and (3) a demonstrated trend of progression in either total CTCs or MCTCs. In the validation group, Kaplan-Meier analysis showed that patients with cM0 (i+) stage had significantly shorter progression-free survival than the control group(P<0.05). The results of multivariate Cox regression analysis also showed cM0 (i+) was an independent risk factor for postoperative progression of LRCC patients [12.448 (1.874-82.666) P < 0.05]. Its 1-3 years' prediction discrimination is better than that of UISS score and SSIGN score, which was also verified in the validation set.
The study proposed a diagnostic criterion for M0 (i+) stage in LRCC based on postoperative CTCs monitoring. It was identified as an independent risk factor for postoperative progression and demonstrated potential advantages over the UISS and SSIGN scores in internal validation.
美国癌症联合委员会（AJCC）提出的肾细胞癌（RCC）cM0（i+）期诊断标准仍不明确。本研究旨在基于局限性肾细胞癌（LRCC）患者术后循环肿瘤细胞（CTC）监测建立并验证cM0（i+）期标准。
本研究纳入了2015年1月至2021年11月期间接受部分或根治性肾切除术的204例LRCC患者。病例随机分为测试集和验证集。分析临床病理特征与CTC计数之间的相关性，并通过Lasso回归确定预后变量。绘制与预后相关的CTC指标的受试者工作特征曲线，以确定其最佳截断值，从而建立cM0（i+）期标准。通过Kaplan-Meier分析和Log-rank检验探讨其临床预后意义。上述分析使用SPSS26.0软件和R Studio软件进行。P < 0.05被认为具有统计学意义。
本研究共分析了204例患者。验证集和测试集之间的变量无显著差异（P>0.05）。通过相关性分析和Lasso回归，选择总CTC、间充质CTC（MCTC）以及呈进展趋势的CTC作为cM0（i+）期的诊断依据。cM0（i+）期定义为同时符合以下标准的患者：（1）总CTC≥6；（2）MCTC≥1；（3）总CTC或MCTC呈进展趋势。在验证组中，Kaplan-Meier分析显示，cM0（i+）期患者的无进展生存期明显短于对照组（P<0.05）。多因素Cox回归分析结果还显示，cM0（i+）是LRCC患者术后进展的独立危险因素[12.448（1.874 - 82.666），P < 0.05]。其1至3年的预测辨别能力优于UISS评分和SSIGN评分，这在验证集中也得到了验证。
本研究基于术后CTC监测提出了LRCC中M0（i+）期的诊断标准。它被确定为术后进展的独立危险因素，并且在内部验证中显示出相对于UISS和SSIGN评分的潜在优势。
