Universität zu Köln

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:	Creators Email ORCID ORCID Put Code O'Brien, Susan UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillmen, Peter UNSPECIFIED orcid.org/0000-0001-5617-4403 UNSPECIFIED Coutre, Steven UNSPECIFIED UNSPECIFIED UNSPECIFIED Barr, Paul M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fraser, Graeme UNSPECIFIED UNSPECIFIED UNSPECIFIED Tedeschi, Alessandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Burger, Jan A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dilhuydy, Marie-Sarah UNSPECIFIED UNSPECIFIED UNSPECIFIED Hess, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Moreno, Carol UNSPECIFIED UNSPECIFIED UNSPECIFIED Cramer, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Liu, Emily UNSPECIFIED UNSPECIFIED UNSPECIFIED Chang, Stephen UNSPECIFIED UNSPECIFIED UNSPECIFIED Vermeulen, Jessica UNSPECIFIED UNSPECIFIED UNSPECIFIED Styles, Lori UNSPECIFIED UNSPECIFIED UNSPECIFIED Howes, Angela UNSPECIFIED UNSPECIFIED UNSPECIFIED James, Danelle F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Patel, Kalpesh UNSPECIFIED UNSPECIFIED UNSPECIFIED Graef, Thorsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Valentino, Rudolph UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language SINGLE-AGENT IBRUTINIB; ATRIAL-FIBRILLATION; CLL; CANCER; PNEUMONIA Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/17100