O'Brien, Susan, Hillmen, Peter ORCID: 0000-0001-5617-4403, Coutre, Steven, Barr, Paul M., Fraser, Graeme, Tedeschi, Alessandra, Burger, Jan A., Dilhuydy, Marie-Sarah, Hess, Georg, Moreno, Carol, Cramer, Paula, Liu, Emily, Chang, Stephen, Vermeulen, Jessica, Styles, Lori, Howes, Angela, James, Danelle F., Patel, Kalpesh, Graef, Thorsten and Valentino, Rudolph (2018). Safety Analysis of Four Randomized Controlled Studies of Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Mantle Cell Lymphoma. Clin. Lymphoma Myeloma Leuk., 18 (10). S. 648 - 673. DALLAS: CIG MEDIA GROUP, LP. ISSN 2152-2669

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Abstract

Ibrutinib, a Bruton's tyrosine kinase inhibitor, has become a standard treatment for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The present pooled safety analysis of 4 randomized controlled studies demonstrated a favorable benefit/risk profile for ibrutinib in patients with CLL/SLL and mantle cell lymphoma. Background: Multiple studies have demonstrated the efficacy and safety of ibrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL). This first-in-class inhibitor of Bruton's tyrosine kinase has become a standard treatment for patients with CLL and MCL. Patients and Methods: We conducted an integrated safety analysis to characterize the frequency, severity, natural history, and outcomes of adverse events (AEs) with ibrutinib versus comparators. Data were pooled from 4 completed randomized controlled studies that had included 756 ibrutinib-treated and 749 comparator-treated patients with CLL/SLL or relapsed/refractory MCL. Safety analyses included reporting of AEs using crude and exposure-adjusted incidence rates. Results: The median treatment duration was 13.3 months (maximum, 28.2 months) for ibrutinib and 5.8 months (maximum, 27.3 months) for comparators. When adjusted for exposure, diarrhea, atrial fibrillation, and hypertension were the only common grade >= 3 AEs more often reported with ibrutinib than with the comparators. Dose reductions (7% vs. 14%) and discontinuation (12% vs. 16%) because of AEs occurred less often with ibrutinib, and deaths due to AEs occurred at similar rates (6% vs. 7%). When adjusted for exposure, the corresponding data were all lower with ibrutinib than with the comparators (0.06 vs. 0.22, 0.11 vs. 0.22, and 0.06 vs. 0.09 patient-exposure-years, respectively). The prevalence of common grade 3/4 AEs with ibrutinib generally decreased over time, with the exception of hypertension. Conclusion: These results from an integrated analysis support a favorable benefit/risk profile of ibrutinib in patients with CLL/SLL and MCL. (C) 2018 The Authors. Published by Elsevier Inc.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
O'Brien, SusanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hillmen, PeterUNSPECIFIEDorcid.org/0000-0001-5617-4403UNSPECIFIED
Coutre, StevenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barr, Paul M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fraser, GraemeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tedeschi, AlessandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burger, Jan A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dilhuydy, Marie-SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hess, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moreno, CarolUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Liu, EmilyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chang, StephenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vermeulen, JessicaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Styles, LoriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Howes, AngelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
James, Danelle F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Patel, KalpeshUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graef, ThorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Valentino, RudolphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-171008
DOI: 10.1016/j.clml.2018.06.016
Journal or Publication Title: Clin. Lymphoma Myeloma Leuk.
Volume: 18
Number: 10
Page Range: S. 648 - 673
Date: 2018
Publisher: CIG MEDIA GROUP, LP
Place of Publication: DALLAS
ISSN: 2152-2669
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SINGLE-AGENT IBRUTINIB; ATRIAL-FIBRILLATION; CLL; CANCER; PNEUMONIAMultiple languages
Oncology; HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/17100

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