DOI: 10.1101/19013433Dec 4, 2019Paper

Evaluation of Prognostic Utility of Tumor Mutation Burden for Non Small Cell Lung Cancer (NSCLC) response to Immune Checkpoint Blockade Therapy: A Single Institute Study

MedRxiv : the Preprint Server for Health Sciences
J. R. ClemenceauTae Hyun Hwang

Abstract

IMPORTANCE: The role of Tumor Mutation Burden (TMB) as a prognostic and/or predictive biomarker for Immune Checkpoint Blockade (ICB) therapy in a real-world clinical setting is still unclear. OBJECTIVE: To assess whether TMB status provided by a clinically and commercially available tumor genomic profiling (TGP) assay is associated with overall survival of Non-Small Cell Lung Cancer (NSCLC) patients treated with ICB from a single institute. DESIGN, SETTING, AND PARTICIPANTS: Outcomes and genetic testing data were collected for 188 NSCLC patients treated within the Cleveland Clinic system between August 2012 and July 2017. MAIN OUTCOMES AND MEASURES: Overall survival (OS) from time receiving ICB therapy. RESULTS: Among 188 patients with NSCLC (median age, 62 years; 49.5% female), 86 (45.7%) received ICB therapy. Patients were grouped into three categories based on the status of TMB (in mutations/Mb): high (>= 20/Mb), intermediate (>=5 to <= 20/Mb), and low (<5/Mb). In patients treated with ICB, TMB high status was not significantly associated with improved OS from therapy initiation (HR: 0.90 [95% CI, 0.52-2.49, P>0.8], median OS difference: 9.7 months). CONCLUSIONS AND RELEVANCE: Among patients with NSCLC from a single institut...Continue Reading

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