Tumor lysis, adverse events, and dose adjustments in 297 venetoclax-treated CLL patients in routine clinical practice

Abstract

Purpose: Clinical trials of venetoclax reported negligible imaging prior to venetoclax initiation. Clinical TLS occurred rates of clinical tumor lysis syndrome (TLS) in patients with in 2.7% of patients and laboratory TLS occurred in 5.7%. chronic lymphocytic leukemia (CLL) when using an extended Pre-venetoclax TLS risk group and creatinine clearance inde-dose escalation schedule. We aimed to understand TLS pro-pendently predict TLS development in multivariable anal-phylaxis, rates of select adverse events (AE), and impact of ysis. Grade 3/4 AEs included neutropenia (39.6%), throm-dosing modifications in routine clinical practice. bocytopenia (29.2%), infection (25%), neutropenic fever Experimental Design: This retrospective cohort study (7.9%), and diarrhea (6.9%). Twenty-two patients (7.4%) included 297 CLL venetoclax-treated patients outside of clin-discontinued venetoclax due to an AE. Progression-free ical trials in academic and community centers. Demographics, survival was similar regardless of number of dose interrup-baseline disease characteristics, venetoclax dosing, TLS risk tions, length of dose interruption, and stable venetoclax and prophylaxis, and AEs were collected. dose. Results: The group was 69% male, 96% had relapsed/ Conclusions: These data provide insights into current use of refractory CLL, 45% had deletion chromosome 17p, 84% venetoclax in clinical practice, including TLS rates observed in had unmutated IGHV, 80% received venetoclax monother-clinical practice. We identified opportunities for improved apy, and median age was 67. TLS risk was categorized as low adherence to TLS risk stratification and prophylaxis, which (40%), intermediate (32%), or high (28%), and 62% had may improve safety.