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Genomic Alterations Of Bone Metastases In Stage Iv Non-Small Cell Lung Cancer (Nsclc) And Real-World Outcomes

P. J. Voon,G. J. Riely, E. M. Lepisto,J. A. Lavery,J. L. Warner, M. L. Lenoue-Newton, S. M. Sweeney,C. G. Mccarthy, B. Samantha,K. S. Panageas,J. Weiss,C. Yu,A. Sacher, K. L. Kehl,N. Leighl,D. Schrag,P. Bedard

ANNALS OF ONCOLOGY(2021)

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Abstract
Bone metastases (BMs) occur in 20-40% of metastatic NSCLC. BMs adversely affect patient (pt) quality of life and are associated with increased mortality, but have not been typically used as stratification factor for clinical trials. Our aim was to evaluate genomic alterations associated with BMs at diagnosis in NSCLC and their impact on survival outcomes. The AACR GENIE Biopharma Collaborative (BPC) is a registry of clinical and genomic data from patients with NSCLC who had tumor sequencing (55-500 genes) from 2015-2017 at four academic centers. Imaging reports and medical oncologists’ clinical notes were retrospectively curated using the PRISSMM framework. Kaplan–Meier (KM) method was used to estimate the median overall survival (OS). Hazard ratio (HR) and 95% confidence intervals (95% CI) were calculated using the Cox Proportional-Hazards Model with survival endpoints adjusted for left truncation introduced by the study inclusion criteria. Association between variables and BMs were analyzed using Mann-Whitney U and Fisher’s exact test. There were 722 pts with Stage IV NSCLC in the BPC cohort, including 297 (41.1%) with BMs at diagnosis. Median OS from diagnosis was worse in pts with BMs vs without BMs (median 12.5 vs 18.2 months (m), HR 1.31; 95% CI 1.09-1.56). BMs at diagnosis was associated with worse OS in multivariate analysis after adjusting for age, sex, smoking, histology, and site of distant metastasis including brain and liver metastasis (HR 1.37; 95% CI 1.13-1.65). EGFRmut was associated with BMs vs no BMs (35% vs 23%, p<0.001). Ex19del (p=0.01) but not L858R (p=0.29) was associated with BMs. Median OS for EGFRmut pts with BMs was 25.4 vs 32.2 m in those without BMs (HR 1.42, 95% CI 0.99-2.03). OS from diagnosis was significantly worse in pts with BMs who had KRASmut (median 5.2 vs 12.0 m, p<0.01) or concurrent EGFRmut/TP53mut (median 22.2 vs 29.6 m, p=0.045) vs no BMs with these mutations. BMs at diagnosis in stage IV NSCLC are associated with EGFRmut, specifically EGFR ex19del, and worse survival despite adjusting for other known prognostic factors. BMs should be considered as a stratification factor for clinical trials in advanced NSCLC.
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Key words
bone metastases,cell lung cancer,lung cancer,non-small,real-world
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