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Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice.

Publication ,  Journal Article
Roeker, LE; Fox, CP; Eyre, TA; Brander, DM; Allan, JN; Schuster, SJ; Nabhan, C; Hill, BT; Shah, NN; Lansigan, F; Yazdy, M; Cheson, BD; Goy, A ...
Published in: Clin Cancer Res
July 15, 2019

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. 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. 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. 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.

Duke Scholars

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Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

July 15, 2019

Volume

25

Issue

14

Start / End Page

4264 / 4270

Location

United States

Related Subject Headings

  • Tumor Lysis Syndrome
  • Treatment Outcome
  • Sulfonamides
  • Retrospective Studies
  • Proto-Oncogene Proteins c-bcl-2
  • Practice Patterns, Physicians'
  • Patient Safety
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
 

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Roeker, L. E., Fox, C. P., Eyre, T. A., Brander, D. M., Allan, J. N., Schuster, S. J., … Mato, A. R. (2019). Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice. Clin Cancer Res, 25(14), 4264–4270. https://doi.org/10.1158/1078-0432.CCR-19-0361
Roeker, Lindsey E., Christopher P. Fox, Toby A. Eyre, Danielle M. Brander, John N. Allan, Stephen J. Schuster, Chadi Nabhan, et al. “Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice.Clin Cancer Res 25, no. 14 (July 15, 2019): 4264–70. https://doi.org/10.1158/1078-0432.CCR-19-0361.
Roeker LE, Fox CP, Eyre TA, Brander DM, Allan JN, Schuster SJ, et al. Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice. Clin Cancer Res. 2019 Jul 15;25(14):4264–70.
Roeker, Lindsey E., et al. “Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice.Clin Cancer Res, vol. 25, no. 14, July 2019, pp. 4264–70. Pubmed, doi:10.1158/1078-0432.CCR-19-0361.
Roeker LE, Fox CP, Eyre TA, Brander DM, Allan JN, Schuster SJ, Nabhan C, Hill BT, Shah NN, Lansigan F, Yazdy M, Cheson BD, Lamanna N, Singavi AK, Coombs CC, Barr PM, Skarbnik AP, Shadman M, Ujjani CS, Tuncer HH, Winter AM, Rhodes J, Dorsey C, Morse H, Kabel C, Pagel JM, Williams AM, Jacobs R, Goy A, Muralikrishnan S, Pearson L, Sitlinger A, Bailey N, Schuh A, Kirkwood AA, Mato AR. Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice. Clin Cancer Res. 2019 Jul 15;25(14):4264–4270.

Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

July 15, 2019

Volume

25

Issue

14

Start / End Page

4264 / 4270

Location

United States

Related Subject Headings

  • Tumor Lysis Syndrome
  • Treatment Outcome
  • Sulfonamides
  • Retrospective Studies
  • Proto-Oncogene Proteins c-bcl-2
  • Practice Patterns, Physicians'
  • Patient Safety
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male