Performance and Prognostic Relevance of Lymph Node Assessment by One-Step Nucleic Acid Amplification Assay in Rectal Cancer : A Multicenter Study
Liu, Qing (Institut de Investigacions Biomèdiques Agustí Pi i Sunyer)
López-Prades, Sandra (Hospital Clínic i Provincial de Barcelona)
Saez de Gordoa, Karmele (Hospital Clínic i Provincial de Barcelona)
Rodrigo-Calvo, Maria Teresa (Hospital Clínic i Provincial de Barcelona)
Garcia Gerona, Mireia (Hospital Clínic i Provincial de Barcelona)
Ruiz Martin, Juan (Hospital Universitario de Toledo)
Romo-Navarro, Ángel (Hospital Universitario de Toledo)
Pinilla Pagnon, Ignacio (Hospital Universitario Severo Ochoa)
Tarragona, Jordi (Hospital Arnau de Vilanova (Lleida, Catalunya))
Otero Alén, Begoña (Complejo Hospitalario Universitario de A Coruña)
Camps, Jordi (Universitat Autònoma de Barcelona. Departament de Biologia Cel·lular, de Fisiologia i d'Immunologia)
Archilla, Ivan (Hospital Clínic i Provincial de Barcelona)
Cuatrecasas, Miriam (Hospital Clínic i Provincial de Barcelona)

Fecha:	2025
Resumen:	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. Methods: 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. Results: 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. Conclusions: 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.
Ayudas:	Instituto de Salud Carlos III PI20/00863 Agència de Gestió d'Ajuts Universitaris i de Recerca 2017/SGR-1035
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Rectal carcinoma ; Lymph node metastases ; Staging ; Diagnosis ; Prognosis ; OSNA
Publicado en:	Cancers, Vol. 17 Núm. 13 (july 2025) , p. 2141, ISSN 2072-6694

DOI: 10.3390/cancers17132141
PMID: 40647439

17 p, 2.0 MB

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