https://orcid.org/0000-0002-7265-4076
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Abstract
Objectives
To evaluate the trend in cytogenetic/molecular testing rate in chronic lymphocytic leukemia (CLL) and assess the clinical and economic burden of first-line (1 L) treatment with chemoimmunotherapy (CIT) by risk status.
Methods
This retrospective cohort study identified patients with CLL from a U.S. managed care population. Medical records were obtained for eligible patients who initiated 1 L CIT between 1/1/2007 and 7/31/2019 and underwent prognostic testing to classify them as high risk (del(17p), TP53 mutation, del(11q), unmutated IGHV or complex karyotype) or as non-high risk by FISH only (non-del(17p) and non-del(11q)). Study outcomes included testing rate, time to next treatment (TTNT) or death, time to treatment failure (defined as time to change of therapy, non-chemotherapy intervention, hospice care or death), and total plan paid costs (medical + pharmacy) per patient per month (PPPM) in the 1 L period. Cox proportional hazard models and generalized linear models were used to calculate adjusted hazard ratio or rate ratio.
Results
Among the 1,808 patients with CLL, 612 were FISH or IGHV tested and the rate of testing increased from 30% to 44% from 2007–2019. High-risk patients (n = 119) had 65% higher risk of next treatment or death (median time: 2.4 vs 3.7 years), 65% higher risk of treatment failure (median time: 3.0 vs 4.9 years), and 33% higher costs ($12,194 vs $9,055, p = 0.027) during 1 L treatment than non-high risk patients (n = 134).
Conclusions
High-risk CLL patients treated with 1 L chemoimmunotherapy have poorer clinical and economic outcomes compared to non-high risk patients. Assessment of genetic risk remains suboptimal.
Transparency
Declaration of funding
This study was funded by Janssen Scientific Affairs LLC.
Declaration of financial/other relationships
Nilesh Gangan and Hiangkiat Tan are employees of HealthCore, Inc., an independent research organization that received funding from Janssen Scientific Affairs, LLC for the conduct of the study. Qing Huang is an employee of Janssen Scientific Affairs, LLC. Lori Leslie is a consultant to Janssen Scientific Affairs, LLC. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
Dr. Leslie was involved in conceptualization of the study, interpretation of data, critical revision of the manuscript for important intellectual content, and giving final approval of the version to be published; Dr. Gangan was involved in design of the study, analysis and interpretation of data, drafting of the manuscript and giving final approval of the version to be published; Mr. Tan was involved in conceptualization and design of the study, interpretation of data, critical revision of the manuscript for important intellectual content and giving final approval of the version to be published; Dr. Huang was involved in conceptualization and design of the study, interpretation of data, critical revision of the manuscript for important intellectual content and giving final approval of the version to be published.
Acknowledgements
Elizabeth Apgar provided writing and other editorial support for this manuscript. Mark Paullin and Manasi Vinod helped with physician outreach and medical chart abstraction process.
Data availability statement
The data that support the findings of this study are available from the corresponding author, NG, upon reasonable request.
Ethical approval
The authors state that they have obtained appropriate institutional review board approval and that the study received a Health Insurance Portability and Accountability Act (HIPAA) waiver of authorization.
Previous presentations
The research abstract was accepted for publication in the Journal of Clinical Oncology as part of submission for American Society of Clinical Oncology (ASCO) 2021 Meeting