Outcomes in chronic lymphocytic leukemia patients on novel agents in the US Veterans Health Administration System

Abstract

The US veteran population has a high proportion of chronic lymphocytic leukemia (CLL) risk factors. Using the Veterans Health Administration (VHA) population, we conducted a retrospective chart review of 1205 CLL patients who initiated treatment with a novel oral agent. For 1L ibrutinib, 33% (n = 107) discontinued therapy during the study, of which 64% discontinued due to adverse events (AEs). For relapsed/refractory (R/R) ibrutinib, 35% (n = 262) discontinued therapy, of which 63% discontinued due to AEs. For R/R venetoclax, 31% (n = 27) discontinued therapy, of which 41% were due to AEs. For idelalisib, 84% (n = 41) discontinued therapy, of which 54% were due to AEs. This real-world study suggests that AEs play an important role in dose reductions and discontinuations; however, physician inexperience in using these drugs when they were first introduced could be part of what is leading to these negative outcomes.

Keywords:

• Chronic lymphocytic leukemia
• adverse events
• novel agents
• discontinuation
• dose reduction
• chart review

Acknowledgments

The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs, the National Institutes of Health, or the authors’ affiliated institutions. The study authors would like to thank Alyssa C. Eaves (student pharmacist at the UT Austin College of Pharmacy) for her creative adaptation of the study enrollment figure.

Author contributions

Study concept and design: CRF, ZN, HL, DM, KR. Statistical analysis: CRF. Interpretation of data: all authors. Drafting of the manuscript: CRF, CJB, CT, ZN, HL, DM, KR. Critical revision of the manuscript for important intellectual content: all authors. Study supervision: CRF and ZN.

Disclosure statement

This study was funded by AstraZeneca.

CRF’s institutions have received grant money, for CRF to perform research, from Allergan (formerly Forest), AstraZeneca, Nabriva, and Pharmacyclics in the last 3 years.

DM, KR and HL are employees and shareholders of AstraZeneca.

MEG, XJ, CJB, KF, MJ-M, DG, SA, SG, JT, RU, PS, ME-G, MMS, CT, OOO-O, and ZN have no conflicts of interest to disclose.

Additional information

Funding

Funding for the study was provided by AstraZeneca as a research grant to the Foundation for Advancing Veterans’ Health Research, a non-profit entity within the Audie L. Murphy Veterans Hospital, San Antonio, TX. Dr. Frei was supported, in part, by an NIH Clinical and Translational Science Award (National Center for Advancing Translational Sciences, UL1 TR002645) while the study was being conducted.