One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)
Por:
Diestro, M, Berjon, A, Zapardiel, I, Yebenes, L, Ruiz, I, Lekuona, A, Rezola, M, Jaunarena, I, Siegrist, J, Sanchez-Pastor, M, Cuadra, M, Sagasta, A, Guerra, I, Lete, L, Roldan, F, Marta, C, Boillos, M, Cardiel, M, Lopez-de la Manzanara, C, Relea, F, Coronado, P, Pascual, A, Roman, M, Peiro, G, Matute, L, Montero, B, Muruzabal, J, Guarch, R, Zorrero, C, Calatrava, A, Ribot, L, Costa, I, Hernandez, A and Hardisson, D
Publicada:
1 sep 2021
Ahead of Print:
4 sep 2021
Resumen:
Simple Summary 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 mu m 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/mu L), 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.
Filiaciones:
Diestro, M:
Univ Autonoma Madrid, Hosp Univ La Paz, Hosp La Paz Inst Hlth Res IdiPAZ, Fac Med,Gynecol Oncol Unit,Dept Gynecol & Obstet, Madrid 28046, Spain
Berjon, A:
Univ Autonoma Madrid, Hosp Univ La Paz,CIBERONC,Fac Med, Hosp La Paz Inst Hlth Res IdiPAZ,Ctr Biomed Res C, Dept Pathol,Inst Salud Carlos III,Mol Pathol & Th, Madrid 28046, Spain
Zapardiel, I:
Univ Autonoma Madrid, Hosp Univ La Paz, Hosp La Paz Inst Hlth Res IdiPAZ, Fac Med,Gynecol Oncol Unit,Dept Gynecol & Obstet, Madrid 28046, Spain
Yebenes, L:
Univ Autonoma Madrid, Hosp Univ La Paz,CIBERONC,Fac Med, Hosp La Paz Inst Hlth Res IdiPAZ,Ctr Biomed Res C, Dept Pathol,Inst Salud Carlos III,Mol Pathol & Th, Madrid 28046, Spain
Ruiz, I:
Hosp Univ Donostia Osakidetza, Dept Pathol, Donostia San Sebastian 20014, Spain
Lekuona, A:
Hosp Univ Donostia Osakidetza, Dept Gynecol, Donostia San Sebastian 20014, Spain
Rezola, M:
Hosp Univ Donostia Osakidetza, Dept Pathol, Donostia San Sebastian 20014, Spain
Jaunarena, I:
Hosp Univ Donostia Osakidetza, Dept Gynecol, Donostia San Sebastian 20014, Spain
Siegrist, J:
Univ Autonoma Madrid, Hosp Univ La Paz, Hosp La Paz Inst Hlth Res IdiPAZ, Fac Med,Gynecol Oncol Unit,Dept Gynecol & Obstet, Madrid 28046, Spain
Sanchez-Pastor, M:
Univ Autonoma Madrid, Hosp Univ La Paz, Hosp La Paz Inst Hlth Res IdiPAZ, Fac Med,Gynecol Oncol Unit,Dept Gynecol & Obstet, Madrid 28046, Spain
Cuadra, M:
OSI Araba Hosp Univ, Inst Invest Bioaraba, Dept Gynecol, Vitoria 01009, Spain
Sagasta, A:
OSI Araba Hosp Univ, Inst Invest Bioaraba, Dept Pathol, Vitoria 01009, Spain
Guerra, I:
OSI Araba Hosp Univ, Inst Invest Bioaraba, Dept Pathol, Vitoria 01009, Spain
Lete, L:
OSI Araba Hosp Univ, Inst Invest Bioaraba, Dept Gynecol, Vitoria 01009, Spain
Roldan, F:
Hosp Clin Univ Lozano Blesa, Dept Gynecol, Zaragoza 50009, Spain
Marta, C:
Hosp Clin Univ Lozano Blesa, Dept Pathol, Zaragoza 50009, Spain
Boillos, M:
Hosp Clin Univ Lozano Blesa, Dept Gynecol, Zaragoza 50009, Spain
Cardiel, M:
Hosp Clin Univ Lozano Blesa, Dept Pathol, Zaragoza 50009, Spain
Lopez-de la Manzanara, C:
Univ Castilla La Mancha, Hosp Gen Univ Ciudad Real, Dept Gynecol, Ciudad Real 13005, Spain
Relea, F:
Univ Castilla La Mancha, Hosp Gen Univ Ciudad Real, Dept Pathol, Ciudad Real 13005, Spain
Coronado, P:
Univ Complutense Madrid, Hosp Clin Univ San Carlos, Women Hlth Inst, IdISSC, Madrid 28040, Spain
Pascual, A:
Hosp Clin Univ San Carlos, Dept Pathol, Madrid 28040, Spain
:
Hosp Gen Univ Alicante, Dept Gynecol, Alicante 03010, Spain
Alicante Inst Hlth & Biomed Res ISABIAL, Alicante 03010, Spain
:
Alicante Inst Hlth & Biomed Res ISABIAL, Alicante 03010, Spain
Hosp Gen Univ Alicante, Dept Pathol, Alicante 03010, Spain
Matute, L:
Hosp Univ & Politecn La Fe, Dept Gynecol, Valencia 46026, Spain
Montero, B:
Hosp Univ & Politecn La Fe, Dept Pathol, Valencia 46026, Spain
Muruzabal, J:
Complejo Hosp Univ Navarra, Dept Gynecol, Pamplona 31008, Spain
Guarch, R:
Complejo Hosp Univ Navarra, Dept Pathol, Pamplona 31008, Spain
Zorrero, C:
Hosp Fdn IVO, Dept Gynecol, Valencia 46009, Spain
Calatrava, A:
Hosp Fdn IVO, Dept Pathol, Valencia 46009, Spain
Ribot, L:
Corp Sanitaria Parc Tauli Sabadell, Dept Gynecol, Barcelona 08208, Spain
Costa, I:
Corp Sanitaria Parc Tauli Sabadell, Dept Pathol, Barcelona 08208, Spain
Hernandez, A:
Univ Autonoma Madrid, Hosp Univ La Paz, Hosp La Paz Inst Hlth Res IdiPAZ, Fac Med,Gynecol Oncol Unit,Dept Gynecol & Obstet, Madrid 28046, Spain
Hardisson, D:
Univ Autonoma Madrid, Hosp Univ La Paz,CIBERONC,Fac Med, Hosp La Paz Inst Hlth Res IdiPAZ,Ctr Biomed Res C, Dept Pathol,Inst Salud Carlos III,Mol Pathol & Th, Madrid 28046, Spain
Green Published, gold
|