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Title: Effective Tumor Debulking with Ibrutinib Before Initiation of Venetoclax: Results from the CAPTIVATE Minimal Residual Disease and Fixed-Duration Cohorts.
Austin Authors: Barr, Paul M;Tedeschi, Alessandra;Wierda, William G;Allan, John N;Ghia, Paolo;Vallisa, Daniele;Jacobs, Ryan;O'Brien, Susan;Grigg, Andrew P ;Walker, Patricia;Zhou, Cathy;Ninomoto, Joi;Krigsfeld, Gabriel;Tam, Constantine S
Affiliation: Peter MacCallum Cancer Center & St. Vincent's Hospital and the University of Melbourne, Melbourne, Victoria, Australia
Peninsula Health and Peninsula Private Hospital, Frankston, Victoria, Australia
Austin Health
Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York..
ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas..
Weill Cornell Medicine, New York, New York.
Division of Experimental Oncology, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy..
Ospedale Guglielmo da Saliceto, Piacenza, Italy.
Levine Cancer Institute, Charlotte, North Carolina.
UC Irvine, Chao Family Comprehensive Cancer Center, Irvine, California.
Pharmacyclics LLC, an AbbVie Company, South San Francisco, California.
Issue Date: 14-Oct-2022
Publication information: Clinical Cancer Research : an Official Journal of the American Association for Cancer Research 2022; 28(20): 4385-4391
Abstract: The phase II CAPTIVATE study investigated first-line treatment with ibrutinib plus venetoclax for chronic lymphocytic leukemia in two cohorts: minimal residual disease (MRD)-guided randomized treatment discontinuation (MRD cohort) and fixed duration (FD cohort). We report tumor debulking and tumor lysis syndrome (TLS) risk category reduction with three cycles of single-agent ibrutinib lead-in before initiation of venetoclax using pooled data from the MRD and FD cohorts. In both cohorts, patients initially received three cycles of ibrutinib 420 mg/day then 12 cycles of ibrutinib plus venetoclax (5-week ramp-up to 400 mg/day). In the total population (N = 323), the following decreases from baseline to after ibrutinib lead-in were observed: percentage of patients with a lymph node diameter ≥5 cm decreased from 31% to 4%, with absolute lymphocyte count ≥25 × 109/L from 76% to 65%, with high tumor burden category for TLS risk from 23% to 2%, and with an indication for hospitalization (high TLS risk, or medium TLS risk and creatinine clearance <80 mL/minute) from 43% to 18%. Laboratory TLS per Howard criteria occurred in one patient; no clinical TLS was observed. Three cycles of ibrutinib lead-in before venetoclax initiation provides effective tumor debulking, decreases the TLS risk category and reduces the need for hospitalization for intensive monitoring for TLS.
DOI: 10.1158/1078-0432.CCR-22-0504
ORCID: 0000-0002-9733-401X
Journal: Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
PubMed URL: 35939599
Type: Journal Article
Appears in Collections:Journal articles

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