Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting

Background: Long-term clinical trials and real-world data have established a comprehensive risk–benefit profile for ibrutinib, informing adverse event (AE) management strategies to optimize safety and efficacy. Methods: We retrospectively assessed the incidence of AEs of special interest and managem...

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Main Authors: Ibraheem Othman, Seyedeh Zahra (Mona) Moossavi, Samaneh Bayati, Yi Sin Chang, Shubrandu Sanjoy, Karolina Grzyb, Eric Sy, Kayla Cropper, Sandy Kassir, Waleed Sabry
Format: Article
Language:English
Published: MDPI AG 2025-05-01
Series:Current Oncology
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Online Access:https://www.mdpi.com/1718-7729/32/6/296
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author Ibraheem Othman
Seyedeh Zahra (Mona) Moossavi
Samaneh Bayati
Yi Sin Chang
Shubrandu Sanjoy
Karolina Grzyb
Eric Sy
Kayla Cropper
Sandy Kassir
Waleed Sabry
author_facet Ibraheem Othman
Seyedeh Zahra (Mona) Moossavi
Samaneh Bayati
Yi Sin Chang
Shubrandu Sanjoy
Karolina Grzyb
Eric Sy
Kayla Cropper
Sandy Kassir
Waleed Sabry
author_sort Ibraheem Othman
collection DOAJ
description Background: Long-term clinical trials and real-world data have established a comprehensive risk–benefit profile for ibrutinib, informing adverse event (AE) management strategies to optimize safety and efficacy. Methods: We retrospectively assessed the incidence of AEs of special interest and management strategies in all patients treated with ibrutinib for chronic lymphocytic leukemia (CLL) in Saskatchewan, Canada, since 2014. Results: Among 187 patients (median age 75.7 years, 63% male), the median time from ibrutinib treatment initiation to data cutoff was 3.1 years. Approximately two-thirds of patients received ibrutinib for relapsed CLL (33.7% second-line and 32.6% third-line and beyond), with 33.7% receiving it first-line. All patients initiated ibrutinib as monotherapy at 420 mg. AEs of interest were observed in 81.3% of patients, with 42.8% experiencing ≥2 AEs. No grade 5 AEs were reported. Among the 284 first-onset AEs observed in 152 patients, 90.8% were successfully managed, allowing treatment continuation. The median time to successful management ranged from 27.0 days (range: 12.5–73.0) for infections to 84.0 days (range: 55.0–141.0) for hypertension. Both AE and discontinuation rates were comparable or favourable to previous reports. Conclusion: This real-world analysis suggests that ibrutinib may be safely used in the majority of CLL patients encountered in routine practice.
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spelling doaj-art-60f47a3ba87144efa2fe003dcee035692025-08-20T03:27:13ZengMDPI AGCurrent Oncology1198-00521718-77292025-05-0132629610.3390/curroncol32060296Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World SettingIbraheem Othman0Seyedeh Zahra (Mona) Moossavi1Samaneh Bayati2Yi Sin Chang3Shubrandu Sanjoy4Karolina Grzyb5Eric Sy6Kayla Cropper7Sandy Kassir8Waleed Sabry9Division of Hematology, Department of Medical Oncology and Hematology, Allan Blair Cancer Centre, Regina, SK S4T 7T1, CanadaCollege of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, CanadaCollege of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, CanadaCollege of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, CanadaEpidemiology and Performance Measurement, Saskatchewan Cancer Agency, Saskatoon, SK S7N 4H4, CanadaResearch Department, Saskatchewan Health Authority, Regina, SK S7K 0M7, CanadaCollege of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, CanadaCollege of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, CanadaResearch Department, Saskatchewan Health Authority, Regina, SK S7K 0M7, CanadaCollege of Medicine, University of Saskatchewan, Saskatoon, SK S7N 5E5, CanadaBackground: Long-term clinical trials and real-world data have established a comprehensive risk–benefit profile for ibrutinib, informing adverse event (AE) management strategies to optimize safety and efficacy. Methods: We retrospectively assessed the incidence of AEs of special interest and management strategies in all patients treated with ibrutinib for chronic lymphocytic leukemia (CLL) in Saskatchewan, Canada, since 2014. Results: Among 187 patients (median age 75.7 years, 63% male), the median time from ibrutinib treatment initiation to data cutoff was 3.1 years. Approximately two-thirds of patients received ibrutinib for relapsed CLL (33.7% second-line and 32.6% third-line and beyond), with 33.7% receiving it first-line. All patients initiated ibrutinib as monotherapy at 420 mg. AEs of interest were observed in 81.3% of patients, with 42.8% experiencing ≥2 AEs. No grade 5 AEs were reported. Among the 284 first-onset AEs observed in 152 patients, 90.8% were successfully managed, allowing treatment continuation. The median time to successful management ranged from 27.0 days (range: 12.5–73.0) for infections to 84.0 days (range: 55.0–141.0) for hypertension. Both AE and discontinuation rates were comparable or favourable to previous reports. Conclusion: This real-world analysis suggests that ibrutinib may be safely used in the majority of CLL patients encountered in routine practice.https://www.mdpi.com/1718-7729/32/6/296chronic lymphocytic leukemiaibrutinibadverse eventstreatment discontinuation
spellingShingle Ibraheem Othman
Seyedeh Zahra (Mona) Moossavi
Samaneh Bayati
Yi Sin Chang
Shubrandu Sanjoy
Karolina Grzyb
Eric Sy
Kayla Cropper
Sandy Kassir
Waleed Sabry
Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting
Current Oncology
chronic lymphocytic leukemia
ibrutinib
adverse events
treatment discontinuation
title Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting
title_full Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting
title_fullStr Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting
title_full_unstemmed Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting
title_short Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting
title_sort ibrutinib in elderly patients with chronic lymphocytic leukemia adverse event incidence management and outcomes in a canadian real world setting
topic chronic lymphocytic leukemia
ibrutinib
adverse events
treatment discontinuation
url https://www.mdpi.com/1718-7729/32/6/296
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