Cardiovascular adverse events in patients with chronic lymphocytic leukemia receiving acalabrutinib monotherapy: pooled analysis of 762 patients
Cardiovascular (CV) toxicities of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib may limit use of this effective therapy in patients with chronic lymphocytic leukemia (CLL). Acalabrutinib is a second-generation BTK inhibitor with greater BTK selectivity. This analysis characterizes pooled CV a...
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Published in | Haematologica (Roma) Vol. 107; no. 6; pp. 1335 - 1346 |
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Main Authors | , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Fondazione Ferrata Storti
01.06.2022
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Abstract | Cardiovascular (CV) toxicities of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib may limit use of this effective therapy in patients with chronic lymphocytic leukemia (CLL). Acalabrutinib is a second-generation BTK inhibitor with greater BTK selectivity. This analysis characterizes pooled CV adverse events (AE) data in patients with CLL who received acalabrutinib monotherapy in clinical trials (clinicaltrials gov. Identifier: NCT02029443, NCT02475681, NCT02970318 and NCT02337829). Acalabrutinib was given orally at total daily doses of 100-400 mg, later switched to 100 mg twice daily, and continued until disease progression or toxicity. Data from 762 patients (median age: 67 years [range, 32-89]; median follow-up: 25.9 months [range, 0-58.5]) were analyzed. Cardiac AE of any grade were reported in 129 patients (17%; grade ≥3, n=37 [5%]) and led to treatment discontinuation in seven patients (1%). The most common any-grade cardiac AE were atrial fibrillation/flutter (5%), palpitations (3%), and tachycardia (2%). Overall, 91% of patients with cardiac AE had CV risk factors before acalabrutinib treatment. Among 38 patients with atrial fibrillation/flutter events, seven (18%) had prior history of arrhythmia or atrial fibrillation/flutter. Hypertension AE were reported in 67 patients (9%), 43 (64%) of whom had a preexisting history of hypertension; no patients discontinued treatment due to hypertension. No sudden cardiac deaths were reported. Overall, these data demonstrate a low incidence of new-onset cardiac AE with acalabrutinib in patients with CLL. Findings from the head-to-head, randomized trial of ibrutinib and acalabrutinib in patients with highrisk CLL (clinicaltrials gov. Identifier: NCT02477696) prospectively assess differences in CV toxicity between the two agents. |
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AbstractList | Cardiovascular (CV) toxicities of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib may limit use of this effective therapy in patients with chronic lymphocytic leukemia (CLL). Acalabrutinib is a second-generation BTK inhibitor with greater BTK selectivity. This analysis characterizes pooled CV adverse events (AE) data in patients with CLL who received acalabrutinib monotherapy in clinical trials (clinicaltrials gov. Identifier: NCT02029443, NCT02475681, NCT02970318 and NCT02337829). Acalabrutinib was given orally at total daily doses of 100-400 mg, later switched to 100 mg twice daily, and continued until disease progression or toxicity. Data from 762 patients (median age: 67 years [range, 32-89]; median follow-up: 25.9 months [range, 0-58.5]) were analyzed. Cardiac AE of any grade were reported in 129 patients (17%; grade ≥3, n=37 [5%]) and led to treatment discontinuation in seven patients (1%). The most common any-grade cardiac AE were atrial fibrillation/flutter (5%), palpitations (3%), and tachycardia (2%). Overall, 91% of patients with cardiac AE had CV risk factors before acalabrutinib treatment. Among 38 patients with atrial fibrillation/flutter events, seven (18%) had prior history of arrhythmia or atrial fibrillation/flutter. Hypertension AE were reported in 67 patients (9%), 43 (64%) of whom had a preexisting history of hypertension; no patients discontinued treatment due to hypertension. No sudden cardiac deaths were reported. Overall, these data demonstrate a low incidence of new-onset cardiac AE with acalabrutinib in patients with CLL. Findings from the head-to-head, randomized trial of ibrutinib and acalabrutinib in patients with highrisk CLL (clinicaltrials gov. Identifier: NCT02477696) prospectively assess differences in CV toxicity between the two agents.Cardiovascular (CV) toxicities of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib may limit use of this effective therapy in patients with chronic lymphocytic leukemia (CLL). Acalabrutinib is a second-generation BTK inhibitor with greater BTK selectivity. This analysis characterizes pooled CV adverse events (AE) data in patients with CLL who received acalabrutinib monotherapy in clinical trials (clinicaltrials gov. Identifier: NCT02029443, NCT02475681, NCT02970318 and NCT02337829). Acalabrutinib was given orally at total daily doses of 100-400 mg, later switched to 100 mg twice daily, and continued until disease progression or toxicity. Data from 762 patients (median age: 67 years [range, 32-89]; median follow-up: 25.9 months [range, 0-58.5]) were analyzed. Cardiac AE of any grade were reported in 129 patients (17%; grade ≥3, n=37 [5%]) and led to treatment discontinuation in seven patients (1%). The most common any-grade cardiac AE were atrial fibrillation/flutter (5%), palpitations (3%), and tachycardia (2%). Overall, 91% of patients with cardiac AE had CV risk factors before acalabrutinib treatment. Among 38 patients with atrial fibrillation/flutter events, seven (18%) had prior history of arrhythmia or atrial fibrillation/flutter. Hypertension AE were reported in 67 patients (9%), 43 (64%) of whom had a preexisting history of hypertension; no patients discontinued treatment due to hypertension. No sudden cardiac deaths were reported. Overall, these data demonstrate a low incidence of new-onset cardiac AE with acalabrutinib in patients with CLL. Findings from the head-to-head, randomized trial of ibrutinib and acalabrutinib in patients with highrisk CLL (clinicaltrials gov. Identifier: NCT02477696) prospectively assess differences in CV toxicity between the two agents. Cardiovascular (CV) toxicities of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib may limit use of this effective therapy in patients with chronic lymphocytic leukemia (CLL). Acalabrutinib is a second-generation BTK inhibitor with greater BTK selectivity. This analysis characterizes pooled CV adverse events (AE) data in patients with CLL who received acalabrutinib monotherapy in clinical trials (clinicaltrials gov. Identifier: NCT02029443, NCT02475681, NCT02970318 and NCT02337829). Acalabrutinib was given orally at total daily doses of 100–400 mg, later switched to 100 mg twice daily, and continued until disease progression or toxicity. Data from 762 patients (median age: 67 years [range, 32–89]; median follow-up: 25.9 months [range, 0–58.5]) were analyzed. Cardiac AE of any grade were reported in 129 patients (17%; grade ≥3, n=37 [5%]) and led to treatment discontinuation in seven patients (1%). The most common any-grade cardiac AE were atrial fibrillation/flutter (5%), palpitations (3%), and tachycardia (2%). Overall, 91% of patients with cardiac AE had CV risk factors before acalabrutinib treatment. Among 38 patients with atrial fibrillation/flutter events, seven (18%) had prior history of arrhythmia or atrial fibrillation/flutter. Hypertension AE were reported in 67 patients (9%), 43 (64%) of whom had a preexisting history of hypertension; no patients discontinued treatment due to hypertension. No sudden cardiac deaths were reported. Overall, these data demonstrate a low incidence of new-onset cardiac AE with acalabrutinib in patients with CLL. Findings from the head-to-head, randomized trial of ibrutinib and acalabrutinib in patients with high-risk CLL (clinicaltrials gov. Identifier: NCT02477696) prospectively assess differences in CV toxicity between the two agents. Cardiovascular (CV) toxicities of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib may limit use of this effective therapy in patients with chronic lymphocytic leukemia (CLL). Acalabrutinib is a second-generation BTK inhibitor with greater BTK selectivity. This analysis characterizes pooled CV adverse events (AE) data in patients with CLL who received acalabrutinib monotherapy in clinical trials (clinicaltrials gov. Identifier: NCT02029443, NCT02475681, NCT02970318 and NCT02337829). Acalabrutinib was given orally at total daily doses of 100-400 mg, later switched to 100 mg twice daily, and continued until disease progression or toxicity. Data from 762 patients (median age: 67 years [range, 32-89]; median follow-up: 25.9 months [range, 0-58.5]) were analyzed. Cardiac AE of any grade were reported in 129 patients (17%; grade ≥3, n=37 [5%]) and led to treatment discontinuation in seven patients (1%). The most common any-grade cardiac AE were atrial fibrillation/flutter (5%), palpitations (3%), and tachycardia (2%). Overall, 91% of patients with cardiac AE had CV risk factors before acalabrutinib treatment. Among 38 patients with atrial fibrillation/flutter events, seven (18%) had prior history of arrhythmia or atrial fibrillation/flutter. Hypertension AE were reported in 67 patients (9%), 43 (64%) of whom had a preexisting history of hypertension; no patients discontinued treatment due to hypertension. No sudden cardiac deaths were reported. Overall, these data demonstrate a low incidence of new-onset cardiac AE with acalabrutinib in patients with CLL. Findings from the head-to-head, randomized trial of ibrutinib and acalabrutinib in patients with highrisk CLL (clinicaltrials gov. Identifier: NCT02477696) prospectively assess differences in CV toxicity between the two agents. |
Author | Ferrajoli, Alessandra Pagel, John M Patel, Priti Moslehi, Javid Byrd, John C Sharman, Jeff P Brown, Jennifer R Sun, Clare Jurczak, Wojciech Furman, Richard R Kuptsova-Clarkson, Nataliya Hillmen, Peter Stephens, Deborah M Ghia, Paolo Tao, Lin |
AuthorAffiliation | 4 Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA 8 Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland 13 Section of Cardio-Oncology & Immunology, Division of Cardiology and the Cardiovascular Research Institute, University of California San Francisco , San Francisco, CA, USA 1 Dana-Farber Cancer Institute , Boston, MA, USA 10 University of Texas MD Anderson Cancer Center , Houston, TX, USA 7 National Heart, Lung, and Blood Institute , Bethesda, MD, USA 2 The Ohio State University Comprehensive Cancer Center , Columbus, OH, USA 3 Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele , Milano, Italy 11 AstraZeneca, South San Francisco, CA, USA 6 University of Utah Huntsman Cancer Institute , Salt Lake City, UT, USA 9 Swedish Cancer Institute , Seattle, WA, USA 14 Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY, USA 12 AstraZeneca, Gaithersburg, MD, USA 5 St. James’s University Hospital , Leeds, UK |
AuthorAffiliation_xml | – name: 2 The Ohio State University Comprehensive Cancer Center , Columbus, OH, USA – name: 9 Swedish Cancer Institute , Seattle, WA, USA – name: 3 Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele , Milano, Italy – name: 4 Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA – name: 10 University of Texas MD Anderson Cancer Center , Houston, TX, USA – name: 8 Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland – name: 5 St. James’s University Hospital , Leeds, UK – name: 1 Dana-Farber Cancer Institute , Boston, MA, USA – name: 12 AstraZeneca, Gaithersburg, MD, USA – name: 14 Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY, USA – name: 11 AstraZeneca, South San Francisco, CA, USA – name: 6 University of Utah Huntsman Cancer Institute , Salt Lake City, UT, USA – name: 7 National Heart, Lung, and Blood Institute , Bethesda, MD, USA – name: 13 Section of Cardio-Oncology & Immunology, Division of Cardiology and the Cardiovascular Research Institute, University of California San Francisco , San Francisco, CA, USA |
Author_xml | – sequence: 1 givenname: Jennifer R surname: Brown fullname: Brown, Jennifer R email: jennifer_brown@dfci.harvard.edu organization: Dana-Farber Cancer Institute, Boston, MA. jennifer_brown@dfci.harvard.edu – sequence: 2 givenname: John C surname: Byrd fullname: Byrd, John C organization: The Ohio State University Comprehensive Cancer Center, Columbus, OH – sequence: 3 givenname: Paolo surname: Ghia fullname: Ghia, Paolo organization: Universita Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano – sequence: 4 givenname: Jeff P surname: Sharman fullname: Sharman, Jeff P organization: Willamette Valley Cancer Institute/US Oncology, Eugene, OR – sequence: 5 givenname: Peter surname: Hillmen fullname: Hillmen, Peter organization: St. James's University Hospital, Leeds – sequence: 6 givenname: Deborah M surname: Stephens fullname: Stephens, Deborah M organization: University of Utah Huntsman Cancer Institute, Salt Lake City, UT – sequence: 7 givenname: Clare surname: Sun fullname: Sun, Clare organization: National Heart, Lung, and Blood Institute, Bethesda, MD – sequence: 8 givenname: Wojciech surname: Jurczak fullname: Jurczak, Wojciech organization: Maria Sklodowska-Curie National Research Institute of Oncology, Krakow – sequence: 9 givenname: John M surname: Pagel fullname: Pagel, John M organization: Swedish Cancer Institute, Seattle, WA – sequence: 10 givenname: Alessandra surname: Ferrajoli fullname: Ferrajoli, Alessandra organization: University of Texas MD Anderson Cancer Center, Houston, TX – sequence: 11 givenname: Priti surname: Patel fullname: Patel, Priti organization: AstraZeneca, South San Francisco, CA – sequence: 12 givenname: Lin surname: Tao fullname: Tao, Lin organization: AstraZeneca, South San Francisco, CA – sequence: 13 givenname: Nataliya surname: Kuptsova-Clarkson fullname: Kuptsova-Clarkson, Nataliya organization: AstraZeneca, Gaithersburg, MD – sequence: 14 givenname: Javid surname: Moslehi fullname: Moslehi, Javid organization: Vanderbilt University Medical Center, Nashville, TN – sequence: 15 givenname: Richard R surname: Furman fullname: Furman, Richard R organization: Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34587719$$D View this record in MEDLINE/PubMed |
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Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Disclosures All authors contributed to data interpretation. Statistical and safety analyses were performed by MB and NK-C. All authors reviewed and provided important intellectual contributions to the manuscript; all authors approved the final version for publication. Contributions JRB has received grants or contracts from Gilead, Loxo/Lilly, Sun, TG Therapeutics, and Verastem/SecuraBio, is a consultant for AbbVie, Acerta/AstraZeneca, BeiGene, Bristol Myers Squibb/Juno/Celgene, Catapult, Dynamo, Eli Lilly, Genentech/Roche, Gilead, Kite, Loxo, MEI Pharma, Morphosys AG, Nextcea, Octapharma, Pfizer, Pharmacyclics, Rigel, Sunesis, TG Therapeutics, and Verastem, has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssen and Teva, and has participated on data safety monitoring or advisory boards for Invectys and Morphosys. JCB is a consultant for AstraZeneca, Trillium, Syndax, Novartis, Kartos, and has ownership in Vercerx. PG has received consulting/advisory fees/honoraria from AbbVie, Acerta/AstraZeneca, Adaptive Bio, ArQule/MSD, BeiGene, Gilead, Janssen, Juno/Celgene/Bristol Myers Squibb, and Loxo/Lilly, and has received research funding from AbbVie, Gilead, Janssen, and Sunesis. JPS is an employee of the US Oncology Network, is a consultant for AbbVie, Acerta/AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, Genentech, Pharmacyclics, Pfizer, and TG Therapeutics, has ownership in VelosBio, and receives research funding from Acerta, Celgene, Genentech, Gilead, Merck, Pharmacyclics, Seattle Genetics, Takeda, and TG Therapeutics. PH has received travel, accommodations, and expenses from AbbVie and Janssen, research funding from AbbVie and Janssen, honoraria and research funding from F. H o fmann-LaRoche, honoraria from AstraZeneca, and research funding from Pharmacyclics and Gilead, and is employed by the University of Leeds. DMS has participated in advisory boards for Adaptive Bio, BeiGene, Epizyme, Karyopharm, and TG Therapeutics, and has received clinical trial funding from Acerta, ArQule, Gilead, Juno, Mingsight, Novartis, Karyopharm, and Verastem. CS has received research funding from Genmab. WJ is a consultant for and currently employed by Maria Sklodowska-Curie National Research Institute of Oncology, has received research funding from and was previously employed by Jagiellonian University, and has received research funding from Janssen, Mei Pharma, Merck, Pharmacyclics, Roche, Takeda, and TG Therapeutics. JMP is a consultant for Actinium, Astra-Zeneca, BeiGene, Gilead, Loxo, and MEI Pharma. AF has nothing to disclose. PP is employed by and a stockholder in AstraZeneca. LT is an employee of AstraZeneca. NK-C is an employee of AstraZeneca. JM is a consultant for Astra-Zeneca, Janssen, Bristol Myers Squibb, Boston Biomedical, Immunocure, Myovant, and Deciphera, and is supported by National Institutes of Health grants (R01HL141466, R01HL155990, and R01HL156021). RRF is a consultant for AbbVie, AstraZeneca, BeiGene, Janssen, Loxo, and Pharmacyclics, has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, AstraZeneca, and Janssen, has received payment for expert testimony from AbbVie, and has participated on a data safety monitoring board or advisory board for Incyte. Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials. pharmacm.com/ST/Submission/Disclosure. Data-sharing statement |
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Snippet | Cardiovascular (CV) toxicities of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib may limit use of this effective therapy in patients with chronic... |
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SubjectTerms | Aged Atrial Fibrillation Benzamides Chronic Lymphocytic Leukemia Humans Hypertension Leukemia, Lymphocytic, Chronic, B-Cell - complications Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Protein Kinase Inhibitors - adverse effects Pyrazines |
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Title | Cardiovascular adverse events in patients with chronic lymphocytic leukemia receiving acalabrutinib monotherapy: pooled analysis of 762 patients |
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