Anaplastic lymphoma kinase rearrangement prevalence in patients with advanced non-small cell lung cancer in the United States - retrospective real world data

Abstract

// Timothy Craig Allen 1 , Yan Xiao 2 , 6 , Baiyu Yang 2 , Denise Croix 3 , Anup Abraham 4 , Stella Redpath 3 , 7 , Julia Engstrom-Melynk 3 , 7 , Roma Shah 2 , Jaya Madala 2 and Eric H. Bernicker 5 1 Department of Pathology, University of Mississippi Medical Center, Jackson, MS, USA 2 Data Services, Roche Information Solutions, Pleasanton, CA, USA 3 Medical and Scientific Affairs, Roche Diagnostics Corporation, Indianapolis, IN, USA 4 Evidence Strategy, Genesis Research, Hoboken, NJ, USA 5 Cancer Center, Houston Methodist Hospital, Houston, TX, USA 6 Current affiliation: Digital Health, AstraZeneca R&D, Beijing, China 7 Current affiliation: Medical Diagnostics, AstraZeneca, Gaithersburg, MD, USA Correspondence to: Eric H. Bernicker, email: [email protected] Keywords: ALK rearrangement; NSCLC; prevalence Abbreviations: aNSCLC: advanced non-small cell lung carcinoma; ALK: anaplastic lymphoma kinase; NSCLC NOS: non-small cell lung carcinoma not otherwise specified; TKI: tryosine kinase inhibitor Received: July 01, 2021     Accepted: October 25, 2021     Published: November 09, 2021 Copyright: © 2021 Allen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. ABSTRACT Objective: This study assessed the prevalence of anaplastic lymphoma kinase (ALK) rearrangements in US oncology practices. Materials and Methods: Using a nationwide real-world database, we included adults with advanced non-small cell lung cancer (aNSCLC, stage IIIB- IV) diagnosed January 2015 – May 2019, with documented ALK testing results and smoking status. Rearrangement prevalence was assessed overall and then stratified by patient characteristics. Results: The cohort included 19,895 eligible patients with a mean age 68.5 years, majority ever-smokers (85.5%) and from community centers (92.2%). The overall ALK rearrangement prevalence was 2.6%. Positivity rate varied by histology and smoking status; it was the highest among non-smoking patients with non-squamous histology (9.3%). Differences in ALK status also varied by age and race, with young patients (18–39 years) having a higher prevalence (21.6%) vs. older patients (age ≥55 = 2.2%); Asian patients had a prevalence of 6.3%. Patients that were positive for other mutations or rearrangements had a lower ALK positivity rate (0.5%) and patients positive for PD-L1 had a rate of 3.0%. Conclusions: The likelihood of finding an ALK translocation was highest in younger patients and nonsmokers; however, age and smoking history were not discriminative enough to exclude testing based on clinical variables.

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