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Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice.
- Source :
-
Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2019 Jul 15; Vol. 25 (14), pp. 4264-4270. Date of Electronic Publication: 2019 Apr 19. - Publication Year :
- 2019
-
Abstract
- Purpose: Clinical trials of venetoclax reported negligible rates of clinical tumor lysis syndrome (TLS) in patients with chronic lymphocytic leukemia (CLL) when using an extended dose escalation schedule. We aimed to understand TLS prophylaxis, rates of select adverse events (AE), and impact of dosing modifications in routine clinical practice.<br />Experimental Design: This retrospective cohort study included 297 CLL venetoclax-treated patients outside of clinical trials in academic and community centers. Demographics, baseline disease characteristics, venetoclax dosing, TLS risk and prophylaxis, and AEs were collected.<br />Results: The group was 69% male, 96% had relapsed/refractory CLL, 45% had deletion chromosome 17p, 84% had unmutated IGHV , 80% received venetoclax monotherapy, and median age was 67. TLS risk was categorized as low (40%), intermediate (32%), or high (28%), and 62% had imaging prior to venetoclax initiation. Clinical TLS occurred in 2.7% of patients and laboratory TLS occurred in 5.7%. Pre-venetoclax TLS risk group and creatinine clearance independently predict TLS development in multivariable analysis. Grade 3/4 AEs included neutropenia (39.6%), thrombocytopenia (29.2%), infection (25%), neutropenic fever (7.9%), and diarrhea (6.9%). Twenty-two patients (7.4%) discontinued venetoclax due to an AE. Progression-free survival was similar regardless of number of dose interruptions, length of dose interruption, and stable venetoclax dose.<br />Conclusions: These data provide insights into current use of venetoclax in clinical practice, including TLS rates observed in clinical practice. We identified opportunities for improved adherence to TLS risk stratification and prophylaxis, which may improve safety.<br /> (©2019 American Association for Cancer Research.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents therapeutic use
Dose-Response Relationship, Drug
Female
Humans
Leukemia, Lymphocytic, Chronic, B-Cell pathology
Male
Middle Aged
Patient Safety
Proto-Oncogene Proteins c-bcl-2 antagonists & inhibitors
Retrospective Studies
Treatment Outcome
Bridged Bicyclo Compounds, Heterocyclic therapeutic use
Drug-Related Side Effects and Adverse Reactions prevention & control
Leukemia, Lymphocytic, Chronic, B-Cell drug therapy
Practice Patterns, Physicians' standards
Sulfonamides therapeutic use
Tumor Lysis Syndrome prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1557-3265
- Volume :
- 25
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- Clinical cancer research : an official journal of the American Association for Cancer Research
- Publication Type :
- Academic Journal
- Accession number :
- 31004001
- Full Text :
- https://doi.org/10.1158/1078-0432.CCR-19-0361