Assessment of a New ROS 1 Immunohistochemistry Clone ( SP 384 ) for the Identification of ROS 1 Rearrangements in Non-Small Cell Lung Carcinoma Patients : the ROSING Study Running title : ROS 1 Immnunohistochemistry with clone SP 384

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

[1]  C. Marquette,et al.  Multicenter Evaluation of a Novel ROS1 Immunohistochemistry Assay (SP384) for Detection of ROS1 Rearrangements in a Large Cohort of Lung Adenocarcinoma Patients. , 2019, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[2]  M. Hellmich,et al.  Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial. , 2019, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[3]  M. Salido,et al.  Next-generation Sequencing for ALK and ROS1 Rearrangement Detection in Patients With Non-small-cell Lung Cancer: Implications of FISH-positive Patterns. , 2019, Clinical lung cancer.

[4]  N. Girard,et al.  Advanced-Stage Non-Small Cell Lung Cancer: Advances in Thoracic Oncology 2018. , 2019, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[5]  M. Ladanyi,et al.  High Yield of RNA Sequencing for Targetable Kinase Fusions in Lung Adenocarcinomas with No Mitogenic Driver Alteration Detected by DNA Sequencing and Low Tumor Mutation Burden , 2019, Clinical Cancer Research.

[6]  A. Nicholson,et al.  MA26.07 ROS1 (SP384) Immunohistochemistry Inter-Reader Precision Between 12 Pathologists , 2018, Journal of Thoracic Oncology.

[7]  L. Sholl.  Recognizing the Challenges of Oncogene Fusion Detection: A Critical Step toward Optimal Selection of Lung Cancer Patients for Targeted Therapies. , 2018, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[8]  I. Menzl,et al.  P2.09-13 Correlation of ROS1 (SP384) Immunohistochemistry with ROS1 Rearrangement Determined by Fluorescence in Situ Hybridization , 2018, Journal of Thoracic Oncology.

[9]  J. Ahn,et al.  Characteristics and Outcome of ROS1‐Positive Non–Small Cell Lung Cancer Patients in Routine Clinical Practice , 2018, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[10]  J. Zhao,et al.  A genomic and clinicopathological study of non‐small‐cell lung cancers with discordant ROS1 gene status by fluorescence in‐situ hybridisation and immunohistochemical analysis , 2018, Histopathology.

[11]  Jia Huang,et al.  Efficacy of Crizotinib among Different Types of ROS1 Fusion Partners in Patients with ROS1‐Rearranged Non–Small Cell Lung Cancer , 2018, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[12]  T. Yamanaka,et al.  Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer. , 2018, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[13]  Benjamin Solomon,et al.  Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology , 2018, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[14]  A. Shaw,et al.  Lorlatinib in ALK- or ROS1-rearranged non-small cell lung cancer: an international, multicenter, open-label phase 1 trial , 2017, The Lancet. Oncology.

[15]  Kenneth L. Jones,et al.  Comparison of Molecular Testing Modalities for Detection of ROS1 Rearrangements in a Cohort of Positive Patient Samples , 2017, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[16]  A. Shaw,et al.  Recent Advances in Targeting ROS1 in Lung Cancer , 2017, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[17]  R. Franco,et al.  Detection of ROS1 rearrangement in non-small cell lung cancer: current and future perspectives , 2017, Lung Cancer.

[18]  M. Ahn,et al.  Open-Label, Multicenter, Phase II Study of Ceritinib in Patients With Non-Small-Cell Lung Cancer Harboring ROS1 Rearrangement. , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[19]  L. Bubendorf,et al.  Lonely Driver ROS1. , 2017, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[20]  Lauren L. Ritterhouse,et al.  ROS1 Fusions Rarely Overlap with Other Oncogenic Drivers in Non–Small Cell Lung Cancer , 2017, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[21]  A. Drilon,et al.  Safety and Antitumor Activity of the Multitargeted Pan-TRK, ROS1, and ALK Inhibitor Entrectinib: Combined Results from Two Phase I Trials (ALKA-372-001 and STARTRK-1). , 2017, Cancer discovery.

[22]  N. Pavlakis,et al.  Screening for ROS1 gene rearrangements in non‐small‐cell lung cancers using immunohistochemistry with FISH confirmation is an effective method to identify this rare target , 2017, Histopathology.

[23]  E. Gabrielson,et al.  Heterogeneous expression of PD-L1 in pulmonary squamous cell carcinoma and adenocarcinoma: implications for assessment by small biopsy , 2017, Modern Pathology.

[24]  D. Dias-Santagata,et al.  Immunohistochemical Detection of ROS1 Fusion , 2016, American journal of clinical pathology.

[25]  K. Kerr,et al.  Precision medicine in NSCLC and pathology: how does ALK fit in the pathway? , 2016, Annals of oncology : official journal of the European Society for Medical Oncology.

[26]  A. Marchetti,et al.  Review and Perspectives , 2022 .

[27]  S. Sabour.  Reliability Assurance of EML4-ALK Rearrangement Detection in Non-Small Cell Lung Cancer: A Methodological and Statistical Issue. , 2016, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[28]  A. Nicholson,et al.  A Validation Study for the Use of ROS1 Immunohistochemical Staining in Screening for ROS1 Translocations in Lung Cancer , 2016, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[29]  S. Fox,et al.  Comparison of Methods in the Detection of ALK and ROS1 Rearrangements in Lung Cancer , 2015, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[30]  Roman K. Thomas,et al.  Crizotinib therapy for advanced lung adenocarcinoma and a ROS1 rearrangement: results from the EUROS1 cohort. , 2015, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[31]  Dongmei Lin,et al.  Detection of ROS1 Gene Rearrangement in Lung Adenocarcinoma: Comparison of IHC, FISH and Real-Time RT-PCR , 2015, PloS one.

[32]  K. Arnaoutakis.  Crizotinib in ROS1-rearranged non-small-cell lung cancer. , 2015, The New England journal of medicine.

[33]  F. Hirsch,et al.  ROS1 Immunohistochemistry Among Major Genotypes of Non—Small-Cell Lung Cancer , 2014, Clinical lung cancer.

[34]  E. Mahé.  Comment on ‘Testing for ALK rearrangement in lung adenocarcinoma: a multicenter comparison of immunohistochemistry and fluorescent in situ hybridization’ , 2014, Modern Pathology.

[35]  M. Salido,et al.  Accurate Identification of ALK Positive Lung Carcinoma Patients: Novel FDA-Cleared Automated Fluorescence In Situ Hybridization Scanning System and Ultrasensitive Immunohistochemistry , 2014, PloS one.

[36]  A. Warth,et al.  ROS1 expression and translocations in non‐small‐cell lung cancer: clinicopathological analysis of 1478 cases , 2014, Histopathology.

[37]  T. Kohno,et al.  Immunohistochemical detection of ROS1 is useful for identifying ROS1 rearrangements in lung cancers , 2014, Modern Pathology.

[38]  E. Brambilla,et al.  On the relevance of a testing algorithm for the detection of ROS1-rearranged lung adenocarcinomas. , 2014, Lung cancer.

[39]  P. Jänne,et al.  ROS1 Immunohistochemistry for Detection of ROS1-Rearranged Lung Adenocarcinomas , 2013, The American journal of surgical pathology.

[40]  A. Shaw,et al.  Novel targets in non-small cell lung cancer: ROS1 and RET fusions. , 2013, The oncologist.

[41]  T. Kohno,et al.  ROS1-Rearranged Lung Cancer: A Clinicopathologic and Molecular Study of 15 Surgical Cases , 2013, The American journal of surgical pathology.

[42]  Tatsuo Ito,et al.  Identification of KIF5B-RET and GOPC-ROS1 Fusions in Lung Adenocarcinomas through a Comprehensive mRNA-Based Screen for Tyrosine Kinase Fusions , 2012, Clinical Cancer Research.

[43]  K. Darwiche,et al.  High Prevalence of Concomitant Oncogene Mutations in Prospectively Identified Patients with ROS1‐Positive Metastatic Lung Cancer , 2017, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.