One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer : Spanish Multicenter Study (ENDO-OSNA)
Diestro Tejeda, María Dolores (Hospital Universitario La Paz (Madrid))
Berjón, Alberto (Hospital Universitario La Paz (Madrid))
Zapardiel, Ignacio (Hospital Universitario La Paz (Madrid))
Yébenes, Laura (Hospital Universitario La Paz (Madrid))
Ruiz, Irune (Hospital Universitario Donostia Osakidetza)
Lekuona, Arantza (Hospital Universitario Donostia Osakidetza)
Rezola, Marta (Hospital Universitario Donostia Osakidetza)
Jaunarena, Ibon (Hospital Universitario Donostia Osakidetza)
Siegrist, Jaime (Hospital Universitario La Paz (Madrid))
Sánchez-Pastor, Margarita (Hospital Universitario La Paz (Madrid))
Cuadra, María (OSI Araba Hospital Universitario)
Sagasta, Amaia (OSI Araba Hospital Universitario)
Guerra, Isabel (OSI Araba Hospital Universitario)
Lete, Luis I. (OSI Araba Hospital Universitario)
Roldán, Fernando (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Marta, Carlo B. (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Boillos, María J. (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Cardiel, María J. (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
López-de la Manzanara, Carlos (Hospital General Universitario Ciudad Real)
Relea, Fernanda (Hospital General Universitario Ciudad Real)
Coronado, Pluvio (Hospital Clínico San Carlos (Madrid))
Pascual, Alejandro (Hospital Clínico San Carlos (Madrid))
Román, María J. (Hospital General Universitari Dr. Balmis)
Peiró, Gloria (Hospital General Universitari Dr. Balmis)
Matute, Luis J. (Hospital Universitari i Politècnic La Fe (València))
Montero, Beatriz (Hospital Universitari i Politècnic La Fe (València))
Muruzábal, Juan C. (Complejo Hospitalario Universitario Navarra)
Guarch, Rosa (Complejo Hospitalario Universitario Navarra)
Zorrero, Cristina (Hospital Fundación IVO)
Calatrava, Ana (Hospital Fundación IVO, 46009 Valencia)
Ribot, Laia (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Costa, Irmgard (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Hernández Gutierrez, Alicia (Hospital Universitario La Paz (Madrid))
Hardisson, David (Hospital Universitario La Paz (Madrid))
Universitat Autònoma de Barcelona

Data:	2021
Resum:	One-step nucleic acid amplification (OSNA) is an automated molecular diagnostic assay used to detect metastases by analyzing the levels of cytokeratin 19 mRNA in whole lymph nodes. It has been validated as an accurate and reliable tool for staging in several types of cancers and is included in the National Institute for Health and Care Excellence guidelines for the management of breast cancer. ENDO-OSNA is a large, observational, multicenter study designed to evaluate the efficacy of OSNA for the detection of sentinel lymph node (SLN) metastasis in patients with early-stage endometrial cancer. We found that the OSNA assay shows higher sensitivity, specificity, and diagnostic accuracy in the detection of SLN metastasis, including low-volume metastasis, compared to standard pathological ultrastaging. Moreover, OSNA could aid in the identification of patients with intermediate or high-risk endometrial cancer, and lead to treatment decisions that could improve their prognosis. The objective of this study was to evaluate the efficacy of one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis compared to standard pathological ultrastaging in patients with early-stage endometrial cancer (EC). A total of 526 SLNs from 191 patients with EC were included in the study, and 379 SLNs (147 patients) were evaluated by both methods, OSNA and standard pathological ultrastaging. The central 1 mm portion of each lymph node was subjected to semi-serial sectioning at 200 μm intervals and examined by hematoxylin-eosin and immunohistochemistry with CK19; the remaining tissue was analyzed by OSNA for CK19 mRNA. The OSNA assay detected metastases in 19. 7% of patients (14. 9% micrometastasis and 4. 8% macrometastasis), whereas pathological ultrastaging detected metastasis in 8. 8% of patients (3. 4% micrometastasis and 5. 4% macrometastasis). Using the established cut-off value for detecting SLN metastasis by OSNA in EC (250 copies/μL), the sensitivity of the OSNA assay was 92%, specificity was 82%, diagnostic accuracy was 83%, and the negative predictive value was 99%. Discordant results between both methods were recorded in 20 patients (13. 6%). OSNA resulted in an upstaging in 12 patients (8. 2%). OSNA could aid in the identification of patients requiring adjuvant treatment at the time of diagnosis.
Drets:	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.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Cytokeratin 19 ; Endometrial cancer ; Micrometastases ; One-step nucleic acid amplification ; OSNA ; Sentinel lymph node ; Ultrastaging
Publicat a:	Cancers, Vol. 13 (september 2021) , ISSN 2072-6694

DOI: 10.3390/cancers13174465
PMID: 34503275

12 p, 613.3 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d’Investigació i Innovació Parc Taulí (I3PT)
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