Assessment of a New ROS1 Immunohistochemistry Clone (SP384) for the Identification of ROS1 Rearrangements in Patients with Non-Small Cell Lung Carcinoma : the ROSING Study
Conde, Esther (Hospital Universitario HM Sanchinarro (Madrid))
Hernández, Susana (Hospital Universitario HM Sanchinarro (Madrid))
Martinez, Rebeca (Hospital Universitario HM Sanchinarro (Madrid))
Angulo, Bárbara (Hospital Universitario HM Sanchinarro (Madrid))
de Castro, Javier ![Identificador ORCID](/img/uab/orcid.ico)
(Hospital Universitario La Paz (Madrid))
Collazo-Lorduy, Ana (Hospital Universitario HM Sanchinarro (Madrid))
Jimenez, Beatriz (Hospital Universitario HM Sanchinarro (Madrid))
Muriel, Alfonso
(Hospital Universitario Ramón y Cajal (Madrid))
Mate Sanz, Jose Luís
(Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Morán, Teresa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Aranda, Ignacio (Instituto de Investigación Sanitaria y Biomédica de Alicante)
Massuti, Bartomeu
(Instituto de Investigación Sanitaria y Biomédica de Alicante)
Rojo, Federico
(Centro de Investigación Biomédica en Red de Cáncer)
Dómine Gómez, Manuel
(Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz)
Sansano, Irene
(Hospital Universitari Vall d'Hebron)
Garcia, Felip (Quironsalud Hospital)
Felip, Enriqueta
(Hospital Universitari Vall d'Hebron)
Mancheño, Nuria (Hospital Universitari i Politècnic La Fe (València))
Juan, Óscar
(Hospital Universitari i Politècnic La Fe (València))
Sanz, Julián (Hospital Clínico San Carlos (Madrid))
Gonzalez-Larriba, José Luis (Hospital Clínico San Carlos (Madrid))
Atienza-Cuevas, Lidia (Hospital Universitario Puerta del Mar (Cadis, Andalusia))
Arriola-Arellano, Esperanza (Hospital Universitario Puerta del Mar (Cadis, Andalusia))
Abdulkader, Ihab (Complejo Hospitalario Universitario de Santiago de Compostela)
Garcia-Gonzalez, Jorge (Complejo Hospitalario Universitario de Santiago de Compostela)
Camacho, Carmen (Insular Materno-Infantil University Hospital Complex)
Rodríguez-Abreu, Delvys
(Insular Materno-Infantil University Hospital Complex)
Teixidó, Cristina
(Hospital Clínic i Provincial de Barcelona)
Reguart, Noemi
(Hospital Clínic i Provincial de Barcelona)
Gonzalez-Piñeiro, Ana (Hospital Álvaro Cunqueiro (Vigo))
Lázaro, Martín
(Hospital Álvaro Cunqueiro (Vigo))
Lozano, María Dolores (Clínica Universidad de Navarra)
Gurpide, Alfonso (Clínica Universidad de Navarra)
Gómez-Román, Javier (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Lopez-Brea, M. (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Pijuan, Lara
(Hospital del Mar (Barcelona, Catalunya))
Salido, Marta
(Hospital del Mar (Barcelona, Catalunya))
Arriola, Edurne
(Hospital del Mar (Barcelona, Catalunya))
Company, Amparo (Hospital Clínic Universitari (València))
Insa, Amelia
(Hospital Clínic Universitari (València))
Esteban-Rodriguez, Isabel (Hospital Universitario La Paz (Madrid))
Saiz, Mónica (Hospital Universitario de Cruces (Barakaldo, País Basc))
Azkona, Eider (Hospital Universitario de Cruces (Barakaldo, País Basc))
Álvarez, Ramiro
(Hospital Universitario Miguel Servet (Saragossa))
Artal, Ángel (Hospital Universitario Miguel Servet (Saragossa))
Plaza, María Luz (Hospital Universitario de Gran Canaria Dr. Negrín)
Aguiar de Sousa, Diana
(Hospital Universitario de Gran Canaria Dr. Negrín)
Enguita, Ana Belén (Hospital Universitario 12 de Octubre (Madrid))
Benito, Amparo (Hospital Universitario Ramón y Cajal (Madrid))
Paz-Ares, Luis
(Hospital Universitario 12 de Octubre (Madrid))
Garrido, Pilar
(Centro de Investigación Biomédica en Red de Cáncer)
Lopez-Rios, Fernando (Hospital Universitario HM Sanchinarro (Madrid))
Universitat Autònoma de Barcelona
Data: |
2019 |
Resum: |
Introduction: The ROS1 gene rearrangement has become an important biomarker in NSCLC. The College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology testing guidelines support the use of ROS1 immunohistochemistry (IHC) as a screening test, followed by confirmation with fluorescence in situ hybridization (FISH) or a molecular test in all positive results. We have evaluated a novel anti-ROS1 IHC antibody (SP384) in a large multicenter series to obtain real-world data. Methods: A total of 43 ROS1 FISH-positive and 193 ROS1 FISH-negative NSCLC samples were studied. All specimens were screened by using two antibodies (clone D4D6 from Cell Signaling Technology and clone SP384 from Ventana Medical Systems), and the different interpretation criteria were compared with break-apart FISH (Vysis). FISH-positive samples were also analyzed with next-generation sequencing (Oncomine Dx Target Test Panel, Thermo Fisher Scientific). Results: An H-score of 150 or higher or the presence of at least 70% of tumor cells with an intensity of staining of 2+ or higher by the SP384 clone was the optimal cutoff value (both with 93% sensitivity and 100% specificity). The D4D6 clone showed similar results, with an H-score of at least 100 (91% sensitivity and 100% specificity). ROS1 expression in normal lung was more frequent with use of the SP384 clone (p < 0. 0001). The ezrin gene (EZR)-ROS1 variant was associated with membranous staining and an isolated green signal FISH pattern (p = 0. 001 and p = 0. 017, respectively). Conclusions: The new SP384 ROS1 IHC clone showed excellent sensitivity without compromising specificity, so it is another excellent analytical option for the proposed testing algorithm. |
Ajuts: |
Instituto de Salud Carlos III PI14-01176 Instituto de Salud Carlos III PI17-01001 Instituto de Salud Carlos III PI18-00382 Instituto de Salud Carlos III PT17-0015-0006
|
Nota: |
Altres ajuts: Funding for this study was provided bythe iLUNG Program (B2017/BMD-3884) from the Comunidad de Madrid. |
Drets: |
Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. ![Creative Commons](/img/licenses/by-nc-nd.ico) |
Llengua: |
Anglès |
Document: |
Article ; recerca ; Versió publicada |
Matèria: |
FISH ;
Immunohistochemistry ;
Lung carcinoma ;
Next-generation sequencing ;
ROS1 |
Publicat a: |
Journal of thoracic oncology, Vol. 14 Núm. 12 (december 2019) , p. 2120-2132, ISSN 1556-1380 |
DOI: 10.1016/j.jtho.2019.07.005
PMID: 31349061
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Registre creat el 2020-06-03, darrera modificació el 2024-06-15