1. Effective Tumor Debulking with Ibrutinib Before Initiation of Venetoclax: Results from the CAPTIVATE Minimal Residual Disease and Fixed-Duration Cohorts
- Author
-
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, and Tam, Constantine S
- Subjects
Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Cancer ,Rare Diseases ,Clinical Research ,Hematology ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adenine ,Antineoplastic Combined Chemotherapy Protocols ,Bridged Bicyclo Compounds ,Heterocyclic ,Creatinine ,Cytoreduction Surgical Procedures ,Humans ,Leukemia ,Lymphocytic ,Chronic ,B-Cell ,Neoplasm ,Residual ,Piperidines ,Sulfonamides ,Tumor Lysis Syndrome ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis - Abstract
PurposeThe 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.Patients and methodsIn 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).ResultsIn 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
- Published
- 2022