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Title: | Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma. | Authors: | Tam C.S.;Opat S. ;Simpson D.;Cull G.;Munoz J.;Phillips T.J.;Kim W.S.;Rule S.;Atwal S.K.;Wei R.;Novotny W.;Huang J.;Wang M.;Trotman J. | Monash Health Department(s): | Haematology | Institution: | (Opat) Monash Health, Clayton, VIC, Australia (Tam) Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (Tam) St Vincent s Hospital, Fitzroy, VIC, Australia (Tam) Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia (Tam) Royal Melbourne Hospital, Parkville, VIC, Australia (Opat) Department of Haematology, Monash University, Clayton, VIC, Australia (Simpson) North Shore Hospital, Auckland, New Zealand (Simpson, Atwal, Wei, Novotny, Huang) BeiGene USA, Inc, San Mateo, CA, United States (Cull) Sir Charles Gairdner Hospital, Perth, WA, Australia (Cull) Pathology and Laboratory Medicine, University of Western Australia, Perth, WA, Australia (Munoz) Banner MD Anderson Cancer Center, Gilbert, AZ, United States (Phillips) Division of Hematology and Oncology, University of Michigan, Ann Arbor, MI, United States (Kim) Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Rule) Peninsula Medical School, University of Plymouth, Plymouth, United Kingdom (Wang) University of Texas MD Anderson Cancer Center, Houston, TX, United States (Trotman) Concord Repatriation Hospital, University of Sydney, Sydney, NSW, Australia |
Issue Date: | 17-Dec-2021 | Copyright year: | 2021 | Publisher: | American Society of Hematology | Place of publication: | United States | Publication information: | Blood Advances. 5(12) (pp 2577-2585), 2021. Date of Publication: 22 Jun 2021. | Journal: | Blood Advances | Abstract: | Zanubrutinib, a highly selective Bruton tyrosine kinase inhibitor, was evaluated in a phase 1/2 study in patients with various B-cell malignancies. In the subgroup of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), zanubrutinib was administered as 160 mg twice daily (n 5 14), 320 mg once daily (n 5 18), or #160 mg total dose (n 5 5). Herein, we report results for patients receiving a total daily dose of 320 mg (N 5 32). Median study follow-up was 18.8 months. Eighteen patients discontinued treatment, 10 because of progressive disease and 8 because of adverse events (AEs); 1 AE (peripheral edema) was considered to be related to zanubrutinib treatment. The most common AEs were diarrhea (43.8%), contusion (37.5%), constipation (31.3%), and upper respiratory tract infection (31.3%). Infection was the most commonly reported AE of interest (18.8% of patients experienced grade $3 infection). At least 1 AE of grade $3 was reported in 59.4% of patients; grade $3 AEs that were reported in .2 patients were anemia (12.5%), pneumonia (9.4%), and myalgia (9.4%). Overall response rate was 84%, with 25% achieving a complete response. Median duration of response was 18.5 months. Median progression-free survival (PFS) was 21.1 months. Zanubrutinib was well tolerated and demonstrated activity in patients with R/R MCL. The trial is registered at www.clinicaltrials.gov as #NCT02343120.Copyright © 2021 American Society of Hematology. All rights reserved. | DOI: | http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1182/bloodadvances.2020004074 | PubMed URL: | 34152395 [https://www.ncbi.nlm.nih.gov/pubmed/?term=34152395] | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/44024 | Type: | Article | Subjects: | acute kidney failure allogeneic stem cell transplantation ANCA associated vasculitis anemia apoptosis atrial fibrillation bone marrow biopsy brain infarction cancer survival computer assisted tomography congestive heart failure constipation contusion diarrhea diffuse large B cell lymphoma drug dose reduction drug efficacy drug safety drug tolerability drug withdrawal epistaxis hematoma hematuria hypertension ischemic heart disease mantle cell lymphoma maximum tolerated dose myalgia myelodysplastic syndrome neutropenia peripheral edema pneumonia progression free survival recommended drug dose septic shock thrombocytopenia upper respiratory tract infection bendamustine bilirubin bortezomib rituximab voriconazole warfarin zanubrutinib zanubrutinib/ct computed tomography scanner PET-CT scanner |
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