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Abstract
Venetoclax is a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor approved as continuous monotherapy and in combination with rituximab as fixed-treatment duration for relapsed and refractory chronic lymphocytic leukemia (R/R CLL). DEVOTE was a 24-week, multicenter observational study (NCT03310190) evaluating the safety, healthcare resource utilization (HCRU) and health-related quality of life (HRQoL) of patients initiating venetoclax for R/R CLL in Canada. Overall, 89 patients received 1 dose of venetoclax; 80% had prior exposure (42% resistant) to ibrutinib. Biochemical tumor lysis syndrome (TLS) occurred in five patients. We observed differences in hospitalization across Canadian provinces including in patients at low risk for TLS with no clear impact on TLS incidence. Additionally, a rapid and sustained improvement in several domains of HRQoL was observed during venetoclax initiation. Early adoption of venetoclax was mainly for R/R CLL patients with few treatment options; nonetheless, acceptable toxicity and a positive impact on HRQoL were observed.
Acknowledgments
AbbVie and the authors thank the patients who participated in the study and all study investigators for their contributions. AbbVie Corp. participated in the study design, data review, and the development and approval of this manuscript for publication. All authors had access to the data; participated in the development, review, and approval of the manuscript. AbbVie funded the research for this study. The authors wish to thank, from Alimentiv Inc., Hong Chen and Jim Wang for statistical analysis and support, and John Howell, of John Howell Consulting Inc. for medical writing and editing services in the development of this manuscript, which was funded by AbbVie. The authors also wish to thank Kelly Boyd, Rima El-Hadi, Luiza Manasyan, Karla Manzano Vargas and Vivianne Mourani from AbbVie for clinical operational support. No author has received funding for developing the manuscript. AbbVie provided financial support for the study.
Data sharing
The data that support the findings of this study are available from the corresponding author, VB, upon reasonable request.
Disclosure statement
Nizar Abdel-Samad has served as a consultant to AbbVie, Amgen, Celgene, Janssen Biotech and Roche. Andrew Aw has received honoraria from Abbvie and AstraZeneca accepted into a separate account within the Ottawa Hospital Research Institute, for research/academic use only. Versha Banerji has received research funding from CIHR, LLSC, CancerCare Manitoba Foundation, Research Manitoba, Janssen and AbbVie which are independent of this study. VB has served as a consultant to AbbVie, Janssen AstraZeneca, Gilead, Roche. VB is the PI on Clinical trials from AstraZeneca, Lily Oncology and a SWOG/CCTG cooperative group study. Marie-Pierre Bernard has participated in advisory board for GSK Canada and received honorarium from Janssen. Sathish Gopalakrishnan has received research funding from AbbVie. Annette Hay has received institutional research funding from AbbVie, Roche, Karyopharm, Janssen, Merck and Seattle Genetics. Nathalie Johnson has provided consultancy for Abbvie, Merck, Roche, BMS, Janssen, Seattle Genetics, Lundbeck and has received honoraria from Roche and Lundbeck. Nicole Laferriere has received honoraria from AbbVie, Alexion, Amgen, Astellas, BMS, Gilead, Leo Pharma, Janssen, Novartis, Roche, Sanofi, Takeda, and Teva. Carolyn Owen has received honoraria from AbbVie, AstraZeneca, Janssen, Roche, Merck, Servier, and Incyte. Anthea Peters has participated in advisory boards with AbbVie, AstraZeneca, Roche, Janssen, Incyte; has received honoraria from AbbVie, AstraZeneca and Janssen. Sue Robinson has received honoraria from AbbVie, AstraZeneca, Biogene, Janssen, Roche, Seattle Genetics. Sarah-Jane Bull, Pierre-André Fournier and Adi Klil-Drori are AbbVie employees and may own AbbVie Stocks.