Approach to Personalized Care of the Lung Cancer Patient

Abstract

Identification of predictive biomarkers for targets of molecular therapy is the most reliable basis for selecting lung cancer patients for targeted therapies, a major component of personalized health care. Currently “established” predictive biomarker tests for lung cancer are EGFR mutation analysis and FISH for ALK fusion gene and are the primary focus of Lung Cancer Biomarker Guidelines under development by a joint committee of the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Exclusion based on clinical criteria, such as gender, ethnicity, and smoking status are likely to omit patients who might benefit from targeted therapy and current evidence indicates that tumor morphology is the most reliable criteria for selecting patients for biomarker testing. The pathologist has a crucial role in the selection of which lung cancers receive testing for a particular predictive biomarker, a paradigm shift after decades in which the primary role of the pathologist in patient therapy was to diagnose small cell carcinoma versus non-small cell carcinoma. In the pre-analytic phase of testing, a pathologist must review a representative tissue section to determine the cellularity and purity of the tumor sample being submitted for biomarker testing. Typically, a pathologist administers the molecular diagnostics laboratory, validating tests, interpreting results, and producing reports of results.