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Cited by 137Chronic Lymphocytic Leukemia ResearchLymphoma Diagnosis and TreatmentPharmacovigilance and Adverse Drug Reactions

The DOI matches its Crossref record; 30 of the 31 references it cites were found in a registry or an index.

Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies

Open access
Coutre, Steven E., Byrd, John C., Hillmen, Peter, Barrientos, Jacqueline C., Barr, Paul M., Devereux, Stephen, Robak, Tadeusz, Kipps, Thomas J., Schuh, Anna, Moreno, Carol, Furman, Richard R., Burger, Jan A., O’Dwyer, Michael, Ghia, Paolo, Valentino, Rudolph, Chang, Stephen, Dean, James P., James, Danelle F., O’Brien, Susan M.·2019·Blood Advances
DOI 10.1182/bloodadvances.2018028761PMC PMC6595265
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Abstract

Ibrutinib, a first-in-class once-daily oral Bruton tyrosine kinase inhibitor indicated for chronic lymphocytic leukemia (CLL), is continued until progressive disease or unacceptable toxicity. We conducted an integrated safety analysis of single-agent ibrutinib from randomized phase 3 studies PCYC-1112 (RESONATE, n = 195) and PCYC-1115/1116 (RESONATE-2, n = 135), and examined longer-term safety separately in the phase 1b/2 PCYC-1102/1103 study (n = 94, 420 mg/d). In the integrated analysis (ibrutinib treatment up to 43 months), the most common adverse events (AEs) were primarily grade 1/2; diarrhea (n = 173, 52% any-grade; n = 15, 5% grade 3) and fatigue (n = 119, 36% any-grade; n = 10, 3% grade 3). The most common grade 3/4 AEs were neutropenia (n = 60, 18%) and pneumonia (n = 38, 12%). Over time, prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension increased, but incidence decreased after year 1. AEs led to dose reductions in 42 (13%) patients and permanent discontinuations in 37 (11%); dose modifications due to AEs were most common during year 1 and decreased in frequency thereafter. The most common AEs (preferred term) contributing to discontinuation included pneumonia (n = 4), anemia (n = 3), and atrial fibrillation (n = 3). With long-term follow-up on PCYC-1102/1103 (ibrutinib treatment up to 67 months), grade 3/4 AEs were generally similar to those in the integrated analysis. Overall, A…

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Metadata

Authors
Coutre, S. E., Byrd, J. C., Hillmen, P., Barrientos, J. C., Barr, P. M., Devereux, S., Robak, T., Kipps, T. J., Schuh, A., Moreno, C., Furman, R. R., Burger, J. A., O’Dwyer, M., Ghia, P., Valentino, R., Chang, S., Dean, J. P., James, D. F., & O’Brien, S. M.
Affiliations
  • Stanford Medicine (US)
  • The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (US)
  • Leeds Cancer Centre, St. James’s Institute of Oncology, Leeds, United Kingdom;
  • Hofstra University (US)
  • University of Rochester Medicine (US)
  • National Health Service (GB)
  • Medical University of Lodz (PL)
  • University of California San Diego (US)
  • National Institute for Health and Care Research (GB)
  • Universitat Autònoma de Barcelona (ES)
  • NewYork–Presbyterian Hospital (US)
  • The University of Texas MD Anderson Cancer Center (US)
  • University College Hospital Galway, Galway, Ireland;
  • Vita-Salute San Raffaele University (IT)
  • Pharmacyclics (United States) (US)
  • Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA
ORCID
Venue
Blood Advances
Publisher
American Society of Hematology
Published
2019-06-13
Volume
3
Issue
12
Pages
1799-1807
ISSN
  • 2473-9529 (ISSN-L)
  • 2473-9537
DOI
10.1182/bloodadvances.2018028761
PMC
PMC6595265
OpenAlex
W2952939985
Cited by
134
References
31
Citations by year
2026: 6 · 2025: 22 · 2024: 9 · 2023: 17 · 2022: 23 · 2021: 26 · 2020: 27 · 2019: 3
FWCI
10.85
Type
journal article
Language
en
Open access
Licence
cc-by-nc-nd
Locations
  • Blood Advances (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
  • Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, public-domain)
  • eScholarship (California Digital Library) (submittedVersion, cc-by)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • Pharmacyclics
  • National Cancer Institute (R35CA197734, P30CA016672)
Topics
  • Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
ibrutinib, chronic lymphocytic leukemia, long-term safety, BTK inhibitors, adverse events, diarrhea, fatigue, neutropenia, pneumonia, hypertension, atrial fibrillation, dose reduction, treatment discontinuation, monotherapy
MeSH terms
Adenine, Adult, Aged, Aged, 80 and over, Anemia, Atrial Fibrillation, Diarrhea, Drug Tolerance, Fatigue, Female, Follow-Up Studies, Hemorrhage, Humans, Hypertension, Infections, Male, Middle Aged, Neutropenia, Piperidines, Pneumonia, Pyrazoles, Pyrimidines, Safety, Leukemia, Lymphocytic, Chronic, B-Cell, Prevalence, Protein Kinase Inhibitors

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