Research Papers:

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

Timothy Craig Allen, Yan Xiao, Baiyu Yang, Denise Croix, Anup Abraham, Stella Redpath, Julia Engstrom-Melynk, Roma Shah, Jaya Madala and Eric H. Bernicker _

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Oncotarget. 2021; 12:2308-2315. https://doi.org/10.18632/oncotarget.28114

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Timothy Craig Allen1, Yan Xiao2,6, Baiyu Yang2, Denise Croix3, Anup Abraham4, Stella Redpath3,7, Julia Engstrom-Melynk3,7, Roma Shah2, Jaya Madala2 and Eric H. Bernicker5

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.


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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