Anaplastic lymphoma kinase rearrangement prevalence in patients with advanced non-small cell lung cancer in the United States: retrospective real world data
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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
|Eric H. Bernicker,||email:||firstname.lastname@example.org|
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
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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