Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell malignancies.

Szczegóły
Abstrakt

Tytuł:: Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell malignancies.
Autorzy:: Furman RR; Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY, USA. .
Byrd JC; The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.
Owen RG; St. James's University Hospital, Leeds, UK.
O'Brien SM; Chao Family Comprehensive Cancer Center, University of California-Irvine, Irvine, CA, USA.
Brown JR; Dana-Farber Cancer Institute, Boston, MA, USA.
Hillmen P; St. James's University Hospital, Leeds, UK.
Stephens DM; University of Utah Huntsman Cancer Institute, Salt Lake City, UT, USA.
Chernyukhin N; AstraZeneca, South San Francisco, CA, USA.
Lezhava T; AstraZeneca, South San Francisco, CA, USA.
Hamdy AM; AstraZeneca, South San Francisco, CA, USA.
Izumi R; AstraZeneca, South San Francisco, CA, USA.
Patel P; AstraZeneca, South San Francisco, CA, USA.
Baek M; AstraZeneca, South San Francisco, CA, USA.
Christian B; The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.
Dyer MJS; The Ernest and Helen Scott Haematological Research Institute, University Hospitals of Leicester NHS Trust, Leicester, UK.
Streetly MJ; Guy's Hospital, Guy's and St. Thomas' NHS Foundation Trust, London, UK.
Sun C; National Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Rule S; Plymouth University Medical School, Plymouth, UK.
Wang M; The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ghia P; Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy.
Jurczak W; Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland.
Pagel JM; Swedish Cancer Institute, Seattle, WA, USA.
Sharman JP; Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA.
Źródło:: Leukemia [Leukemia] 2021 Nov; Vol. 35 (11), pp. 3201-3211. Date of Electronic Publication: 2021 Apr 27.
Typ publikacji:: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Publication: 2000- : London : Nature Publishing Group, Specialist Journals
Original Publication: [Baltimore, Md.] : Williams & Wilkins, [c1987-
MeSH Terms:: Antineoplastic Agents/*adverse effects
Benzamides/*adverse effects
Clinical Trials as Topic/*statistics & numerical data
Drug-Related Side Effects and Adverse Reactions/*pathology
Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy
Pyrazines/*adverse effects
Adult ; Aged ; Aged, 80 and over ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/etiology ; Female ; Follow-Up Studies ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell/pathology ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Survival Rate ; United States/epidemiology
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Grant Information:: R35 CA198183 United States CA NCI NIH HHS
Substance Nomenclature:: 0 (Antineoplastic Agents)
0 (Benzamides)
0 (Pyrazines)
I42748ELQW (acalabrutinib)
Entry Date(s):: Date Created: 20210428 Date Completed: 20211230 Latest Revision: 20221018
Update Code:: 20240105
DOI:: 10.1038/s41375-021-01252-y
PMID:: 33907299
: Czasopismo naukowe

Bruton tyrosine kinase (BTK) inhibition is an effective therapy for many B-cell malignancies. Acalabrutinib is a next-generation, potent, highly selective, covalent BTK inhibitor. To characterize acalabrutinib tolerability, we pooled safety data from 1040 patients with mature B-cell malignancies treated with acalabrutinib monotherapy in nine clinical studies (treatment-naïve: n = 366 [35%], relapsed/refractory: n = 674 [65%]; median [range] age: 67 [32-90] years; median [range] prior treatments: 1 [0-13]; median [range] duration of exposure: 24.6 [0.0-58.5] months). The most common adverse events (AEs) were headache (38%), diarrhea (37%), upper respiratory tract infection (22%), contusion (22%), nausea (22%), fatigue (21%), and cough (21%). Serious AEs (SAEs) occurred in 39% of patients; pneumonia (6%) was the only SAE that occurred in ≥2%. Deaths due to AEs occurred in 52 patients (5%); pneumonia (n = 8) was the only fatal AE to occur in ≥3 patients. AEs led to treatment discontinuation in 9%. Rates for the AEs of interest (all grades) included infections (67%), hemorrhages (46%), neutropenia (16%), anemia (14%), second primary malignancies (12%), thrombocytopenia (9%), hypertension (8%), and atrial fibrillation (4%). This pooled analysis confirmed acalabrutinib's tolerability and identified no newly emerging late toxicities, supporting acalabrutinib as a long-term treatment for patients with mature B-cell malignancies.
(© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

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