دورية أكاديمية
An indirect comparison of acalabrutinib with and without obinutuzumab vs zanubrutinib in treatment-naive CLL.
| العنوان: | An indirect comparison of acalabrutinib with and without obinutuzumab vs zanubrutinib in treatment-naive CLL. |
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| المؤلفون: | Kittai AS; Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH., Allan JN; Weill Cornell Medicine, New York, NY., James D; Polaris Biostatistics Ltd, Edinburgh, United Kingdom., Bridge H; AstraZeneca, Cambridge Biomedical Campus, Cambridge, United Kingdom., Miranda M; AstraZeneca, Cambridge Biomedical Campus, Cambridge, United Kingdom., Yong ASM; AstraZeneca, Gaithersburg, MD., Fam F; AstraZeneca, Cambridge Biomedical Campus, Cambridge, United Kingdom., Roos J; AstraZeneca, Gaithersburg, MD., Shetty V; AstraZeneca, Gaithersburg, MD., Skarbnik A; Novant Health Cancer Institute, Lymphoma and CLL Program, Charlotte, NC., Davids MS; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA. |
| المصدر: | Blood advances [Blood Adv] 2024 Jun 11; Vol. 8 (11), pp. 2861-2869. |
| نوع المنشور: | Journal Article; Comparative Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Hematology Country of Publication: United States NLM ID: 101698425 Publication Model: Print Cited Medium: Internet ISSN: 2473-9537 (Electronic) Linking ISSN: 24739529 NLM ISO Abbreviation: Blood Adv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Washington, DC : American Society of Hematology, [2016]- |
| مواضيع طبية MeSH: | Benzamides*/therapeutic use , Benzamides*/administration & dosage , Benzamides*/adverse effects , Antibodies, Monoclonal, Humanized*/therapeutic use , Antibodies, Monoclonal, Humanized*/adverse effects , Antibodies, Monoclonal, Humanized*/administration & dosage , Pyrazines*/administration & dosage , Pyrazines*/therapeutic use , Pyrazines*/adverse effects , Pyrimidines*/therapeutic use , Pyrimidines*/administration & dosage , Pyrimidines*/adverse effects , Pyrazoles*/therapeutic use , Pyrazoles*/administration & dosage , Pyrazoles*/adverse effects , Leukemia, Lymphocytic, Chronic, B-Cell*/drug therapy , Leukemia, Lymphocytic, Chronic, B-Cell*/mortality , Antineoplastic Combined Chemotherapy Protocols*/therapeutic use , Antineoplastic Combined Chemotherapy Protocols*/adverse effects, Humans ; Female ; Male ; Aged ; Middle Aged ; Aged, 80 and over ; Treatment Outcome ; Piperidines |
| مستخلص: | Abstract: The efficacy and safety of acalabrutinib plus obinutuzumab and acalabrutinib monotherapy vs zanubrutinib in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma without del(17p) were compared using an unanchored matching-adjusted indirect comparison. Individual patient-level data from ELEVATE-TN (acalabrutinib plus obinutuzumab, n = 162; acalabrutinib monotherapy, n = 163) were weighted to match published aggregate baseline data from SEQUOIA cohort 1, which excluded patients with del(17p) (zanubrutinib, n = 241), using variables that were prognostic/predictive of investigator-assessed progression-free survival (INV-PFS) in an exploratory Cox regression analysis of ELEVATE-TN. After matching, INV-PFS was longer with acalabrutinib plus obinutuzumab (hazard ratio [HR], 0.41; 95% confidence interval [CI], 0.23-0.74) and comparable with acalabrutinib monotherapy (HR, 0.91; 95% CI, 0.53-1.56) vs zanubrutinib. Acalabrutinib monotherapy had significantly lower odds of any grade hypertension vs zanubrutinib (odds ratio [OR], 0.44; 95% CI, 0.20-0.99), whereas acalabrutinib plus obinutuzumab had significantly higher odds of neutropenia (OR, 2.19; 95% CI, 1.33-3.60) and arthralgia (OR, 2.33; 95% CI, 1.37-3.96) vs zanubrutinib. No other significant differences in safety were observed. In summary, acalabrutinib plus obinutuzumab had longer INV-PFS with increased odds of neutropenia and arthralgia than zanubrutinib, whereas acalabrutinib monotherapy had similar INV-PFS with lower odds of any grade hypertension. These trials were registered at www.ClinicalTrials.gov as #NCT02475681 and #NCT03336333. (© 2024 by The American Society of Hematology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).) |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT03336333; NCT02475681 |
| المشرفين على المادة: | I42748ELQW (acalabrutinib) O43472U9X8 (obinutuzumab) 0 (Benzamides) 0 (Antibodies, Monoclonal, Humanized) AG9MHG098Z (zanubrutinib) 0 (Pyrazines) 0 (Pyrimidines) 0 (Pyrazoles) 0 (Piperidines) |
| تواريخ الأحداث: | Date Created: 20240410 Date Completed: 20240603 Latest Revision: 20240724 |
| رمز التحديث: | 20240726 |
| مُعرف محوري في PubMed: | PMC11176945 |
| DOI: | 10.1182/bloodadvances.2023012142 |
| PMID: | 38598745 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 2473-9537 |
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| DOI: | 10.1182/bloodadvances.2023012142 |