Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLL

Abstract: In patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), high-risk cytogenetic features such as del(17p), del(11q), and unmutated immunoglobulin variable heavy chain (IGHV) may be associated with unfavorable outcomes. In this large retrospective cohort study, d...

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Main Authors: John N. Allan, Tao Ran, Zhijie Ding, Jinghua He, Alex Bokun, Zaina P. Qureshi, Susan M. O’Brien
Format: Article
Language:English
Published: Elsevier 2025-08-01
Series:Blood Advances
Online Access:http://www.sciencedirect.com/science/article/pii/S2473952925002848
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author John N. Allan
Tao Ran
Zhijie Ding
Jinghua He
Alex Bokun
Zaina P. Qureshi
Susan M. O’Brien
author_facet John N. Allan
Tao Ran
Zhijie Ding
Jinghua He
Alex Bokun
Zaina P. Qureshi
Susan M. O’Brien
author_sort John N. Allan
collection DOAJ
description Abstract: In patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), high-risk cytogenetic features such as del(17p), del(11q), and unmutated immunoglobulin variable heavy chain (IGHV) may be associated with unfavorable outcomes. In this large retrospective cohort study, data from a nationwide electronic health record–derived deidentified database were analyzed to assess real-world overall survival (rwOS) among patients treated with first-line (1L) ibrutinib with and without high-risk cytogenetic features (ie, del(17p), del(11q), unmutated IGHV). Inverse probability of treatment weighting was used to account for differences in patient characteristics between cohorts. Of 1242 patients included, 969 and 273 had high- and non–high-risk CLL/SLL, with a mean age of 70.0 and 70.8 years, and a median follow-up of 32 and 31 months, respectively. Within the high-risk cohort, 32.9%, 36.7%, and 58.7% had the presence of del(17p), del(11q), and unmutated IGHV, respectively. The median rwOS was not reached for either cohort; the hazard ratio (HR) comparing rwOS between the 2 cohorts was 1.09 (95% confidence interval [CI], 0.79-1.51). In a sensitivity analysis in which del(11q) was not part of the high-risk definition, similar results were found, with a HR of 1.19 (95% CI, 0.86-1.64) and median rwOS not reached for either cohort. Similarly, among the subgroup of patients with Medicare coverage, the HR was 0.98 (95% CI, 0.63-1.53), and median rwOS was not reached. In this real-world study using a large community health care data set, there was no difference in rwOS between patients treated with 1L ibrutinib with and without high-risk cytogenetic features.
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spelling doaj-art-b94d295ce66b481caa5224a17a1e0ac02025-08-20T03:13:59ZengElsevierBlood Advances2473-95292025-08-019153801380910.1182/bloodadvances.2024015417Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLLJohn N. Allan0Tao Ran1Zhijie Ding2Jinghua He3Alex Bokun4Zaina P. Qureshi5Susan M. O’Brien6Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York, NYJanssen Scientific Affairs, LLC, a Johnson & Johnson Company, Titusville, NJJanssen Scientific Affairs, LLC, a Johnson & Johnson Company, Horsham, PAJanssen Scientific Affairs, LLC, a Johnson & Johnson Company, Titusville, NJJanssen Scientific Affairs, LLC, a Johnson & Johnson Company, Horsham, PAJanssen Scientific Affairs, LLC, a Johnson & Johnson Company, Horsham, PA; Correspondence: Zaina P. Qureshi, Janssen Scientific Affairs, LLC, a Johnson & Johnson company, 800 Ridgeview Dr, Horsham, PA 19044;Division of Hematology and Oncology, Department of Medicine, University of California Irvine, Orange, CAAbstract: In patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), high-risk cytogenetic features such as del(17p), del(11q), and unmutated immunoglobulin variable heavy chain (IGHV) may be associated with unfavorable outcomes. In this large retrospective cohort study, data from a nationwide electronic health record–derived deidentified database were analyzed to assess real-world overall survival (rwOS) among patients treated with first-line (1L) ibrutinib with and without high-risk cytogenetic features (ie, del(17p), del(11q), unmutated IGHV). Inverse probability of treatment weighting was used to account for differences in patient characteristics between cohorts. Of 1242 patients included, 969 and 273 had high- and non–high-risk CLL/SLL, with a mean age of 70.0 and 70.8 years, and a median follow-up of 32 and 31 months, respectively. Within the high-risk cohort, 32.9%, 36.7%, and 58.7% had the presence of del(17p), del(11q), and unmutated IGHV, respectively. The median rwOS was not reached for either cohort; the hazard ratio (HR) comparing rwOS between the 2 cohorts was 1.09 (95% confidence interval [CI], 0.79-1.51). In a sensitivity analysis in which del(11q) was not part of the high-risk definition, similar results were found, with a HR of 1.19 (95% CI, 0.86-1.64) and median rwOS not reached for either cohort. Similarly, among the subgroup of patients with Medicare coverage, the HR was 0.98 (95% CI, 0.63-1.53), and median rwOS was not reached. In this real-world study using a large community health care data set, there was no difference in rwOS between patients treated with 1L ibrutinib with and without high-risk cytogenetic features.http://www.sciencedirect.com/science/article/pii/S2473952925002848
spellingShingle John N. Allan
Tao Ran
Zhijie Ding
Jinghua He
Alex Bokun
Zaina P. Qureshi
Susan M. O’Brien
Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLL
Blood Advances
title Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLL
title_full Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLL
title_fullStr Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLL
title_full_unstemmed Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLL
title_short Real-world survival outcomes in first-line ibrutinib-treated patients with high-risk CLL/SLL
title_sort real world survival outcomes in first line ibrutinib treated patients with high risk cll sll
url http://www.sciencedirect.com/science/article/pii/S2473952925002848
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