Liu Qing, Lopez-Prades Sandra, Saez de Gordoa Karmele, Rodrigo-Calvo Maite, Garcia Mireia, Ruiz Martin Juan, Romo Angel, Pinilla Ignacio, Tarragona Jordi, Alen Begoña Otero, Camps Jordi, Archilla Ivan, Cuatrecasas Miriam
August Pi i Sunyer Biomedical Research Institute (IDIBAPS), 08036 Barcelona, Spain.
Faculty of Medicine and Health Sciences, University of Barcelona, 08036 Barcelona, Spain.
Cancers (Basel). 2025 Jun 25;17(13):2141. doi: 10.3390/cancers17132141.
BACKGROUND/OBJECTIVES: Lymph node metastases (LNM) undetected by standard hematoxylin and eosin (H&E) have been associated with unfavorable prognosis in colorectal cancer. The One-Step Nucleic Acid Amplification (OSNA) assay has demonstrated superior sensitivity in detecting LNM compared to H&E. We aimed to assess the performance of OSNA in detecting LNM, as well as its prognostic value in rectal cancer (RC) patients.
Lymph nodes (LNs) of patients from 15 centers were analyzed by both H&E and OSNA. The total tumor load (TTL) was defined as the sum of cytokeratin 19 mRNA copies/µL in all LNs from a surgical specimen, using a threshold of 250 copies/μL for OSNA positivity. Cox proportional hazard regression was used to assess the effect of TTL ≥ 250 or 6000 copies/μL on cancer-specific survival (CSS) and recurrence-free survival (RFS), with Firth's method applied to account for low event rate.
A total of 97 RC patients were included. Of these, 84 patients were eligible for survival analysis. The sensitivity and specificity of OSNA, compared to H&E, were 91.7% and 84.7%, respectively. TTL ≥ 6000 versus <6000 copies/μL was related to worse CSS and RFS. When dividing TTL into three groups: ≤250, 250-6000, and >6000 copies/μL, only TTL ≥ 6000 copies/μL was significantly associated with worse CSS and RFS.
The OSNA assay is highly sensitive for detecting LNM in RC patients. A TTL of ≥6000 copies/μL could identify a subset of RC patients with worse CSS and RFS who might benefit from adjuvant treatment or intensive surveillance.
背景/目的：标准苏木精-伊红（H&E）染色未检测到的淋巴结转移（LNM）与结直肠癌的不良预后相关。与H&E相比，一步核酸扩增（OSNA）检测在检测LNM方面具有更高的灵敏度。我们旨在评估OSNA在检测LNM方面的性能及其对直肠癌（RC）患者的预后价值。
对来自15个中心的患者的淋巴结（LNs）进行H&E和OSNA分析。总肿瘤负荷（TTL）定义为手术标本中所有淋巴结中细胞角蛋白19 mRNA拷贝数/微升的总和，OSNA阳性阈值为250拷贝/微升。采用Cox比例风险回归评估TTL≥250或6000拷贝/微升对癌症特异性生存（CSS）和无复发生存（RFS）的影响，并应用Firth方法处理低事件率。
共纳入97例RC患者。其中，84例患者符合生存分析条件。与H&E相比，OSNA的灵敏度和特异性分别为91.7%和84.7%。TTL≥6000与<6000拷贝/微升与较差的CSS和RFS相关。将TTL分为三组：≤250、250 - 6000和>6000拷贝/微升时，只有TTL≥6000拷贝/微升与较差的CSS和RFS显著相关。
OSNA检测对RC患者LNM的检测具有高度敏感性。TTL≥6000拷贝/微升可识别出CSS和RFS较差的RC患者亚组，这些患者可能从辅助治疗或强化监测中获益。
