Evaluation of an interdisciplinary venetoclax initiation process in minimizing risk of tumor lysis syndrome

Abstract

Venetoclax is a BCL-2 inhibitor approved for treatment of adult patients with chronic lymphocytic leukemia (CLL). Due to significant risk of tumor lysis syndrome (TLS) upon treatment initiation, a 5-week dose ramp-up is recommended. University of North Carolina Medical Center (UNCMC) utilizes a novel interdisciplinary model of care involving clinical pharmacists (CPs) who oversee the 5-week ramp-up to minimize treatment-related adverse events. The aim of this study was to investigate the effects of a pharmacist-led venetoclax initiation protocol on patient outcomes. The primary objective was to determine the incidence of venetoclax-induced TLS during dose ramp-up in patients managed by a CP. In this cohort (n = 39), there were no cases of TLS during the venetoclax ramp-up. Reduced TLS rates were observed in CP-managed real-world patients compared to previous real-world reports. This real-world analysis supports the utilization of CPs for intensive monitoring of patients initiated on venetoclax.

Keywords:

• Pharmacist
• venetoclax
• CLL
• tumor lysis syndrome
• real-world data

Acknowledgements

The authors gratefully acknowledge Jessica Beers, PharmD and William Zamboni, PharmD, Ph.D., who provided guidance on initial manuscript revisions. Additionally, the authors acknowledge Matthew Loop, Ph.D., who provided guidance on statistical analysis.

Author contributions

Monica Cozad, PharmD Candidate and Benyam Muluneh, PharmD, BCOP, CPP: participated in research design, data analysis, and writing of the manuscript. Sarah E. Stump, PharmD, BCOP: graciously shared unpublished data and preliminary results. Kaitlyn Buhlinger, PharmD, BCOP, CPP and Catherine C. Coombs, MD: participated in research design and data collection methods. James Collins IV, PharmD Candidate: provided assistance with manuscript editing process. Michele Muir, PharmD: provided assistance with manuscript editing process. All authors have thoroughly reviewed and provided revisions to the manuscript.

Disclosure statement

C.C.C. has served as a consultant for AbbVie, LOXO/Lilly, has received honoraria from AbbVie, AstraZeneca, Beigene, Genentech, LOXO/Lilly, MEI Pharma, Novartis, has served on the speaker’s bureau for AbbVie, and has received institutional funding for research from LOXO/Lilly and H3 Biomedicine. B.M.’s spouse is an employee and stockholder of Novartis Pharmaceuticals.

Data availability statement

Study data are available from the primary author, [MC], upon reasonable request.