Testing for EGFR Mutations and ALK Rearrangements in Advanced Non-Small-Cell Lung Cancer: Considerations for Countries in Emerging Markets

Abstract

Mercedes L Dalurzo,1,* Alejandro Avilés-Salas,2,* Fernando Augusto Soares,3,* Yingyong Hou,4,* Yuan Li,5,* Anna Stroganova,6,* Büge Öz,7,* Arif Abdillah,8,* Hui Wan,8,* Yoon-La Choi9,* 1Department of Pathology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina; 2Department of Pathology, Instituto Nacional de Cancerología, Mexico City, Mexico; 3Department of Pathology, A.C. Camargo Cancer Center, São Paulo, Brazil; 4Department of Pathology, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China; 5Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, People’s Republic of China; 6N.N. Blokhin National Medical Research Centre of Oncology, Russian Academy of Medical Sciences, Moscow, Russia; 7Cerrahpaşa School of Medicine, Istanbul University-Cerrahpaşa, Istanbul, Turkey; 8Takeda Pharmaceuticals International AG – Singapore Branch, Singapore, Singapore; 9Department of Pathology and Translational Genomics, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea*These authors contributed equally to this workCorrespondence: Yoon-La ChoiDepartment of Pathology and Translational Genomics, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, South KoreaTel [phone]Fax [phone]Email [email protected]: The treatment of patients with advanced non-small-cell lung cancer (NSCLC) in recent years has been increasingly guided by biomarker testing. Testing has centered on driver genetic alterations involving the epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements. The presence of these mutations is predictive of response to targeted therapies such as EGFR tyrosine kinase inhibitors (TKIs) and ALK TKIs. However, there are substantial challenges for the implementation of biomarker testing, particularly in emerging countries. Understanding the barriers to testing in NSCLC will be key to improving molecular testing rates worldwide and patient outcomes as a result. In this article, we review EGFR mutations and ALK rearrangements as predictive biomarkers for NSCLC, discuss a selection of appropriate tests and review the literature with respect to the global uptake of EGFR and ALK testing. To help improve testing rates and unify procedures, we review our experiences with biomarker testing in China, South Korea, Russia, Turkey, Brazil, Argentina and Mexico, and propose a set of recommendations that pathologists from emerging countries can apply to assist with the diagnosis of NSCLC.Keywords: non-small-cell lung cancer, EGFR testing, ALK testing, immunohistochemistry, FISH, next-generation sequencing

Keywords

• non-small-cell lung cancer
• egfr testing
• alk testing
• immunohistochemistry
• fish
• next-generation sequencing