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

Esther Conde, Susana Hernandez, Rebeca Martinez, Barbara Angulo, Javier De Castro, Ana Collazo-Lorduy, Beatriz Jimenez, Alfonso Muriel, Jose Luis Mate, Teresa Moran, Ignacio Aranda, Bartomeu Massuti, Federico Rojo, Manuel Domine, Irene Sansano, Felip Garcia, Enriqueta Felip, Nuria Mancheño, Oscar Juan, Julian SanzJose Luis Gonzalez-Larriba, Lidia Atienza-Cuevas, Esperanza Arriola-Arellano, Ihab Abdulkader, Jorge Garcia-Gonzalez, Carmen Camacho, Delvys Rodriguez-Abreu, Cristina Teixido, Noemi Reguart, Ana Gonzalez-Piñeiro, Martin Lazaro-Quintela, Maria Dolores Lozano, Alfonso Gurpide, Javier Gomez-Roman, Marta Lopez-Brea, Lara Pijuan, Marta Salido, Edurne Arriola, Amparo Company, Amelia Insa, Isabel Esteban-Rodriguez, Monica Saiz, Eider Azkona, Ramiro Alvarez, Angel Artal, Maria Luz Plaza, David Aguiar, Ana Belen Enguita, Amparo Benito, Luis Paz-Ares, Pilar Garrido, Fernando López-Ríos

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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.
Idioma originalEnglish
Pàgines (de-a)2120-2132
Nombre de pàgines13
RevistaJournal of Thoracic Oncology
Estat de la publicacióPublicada - de des. 2019


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