دورية أكاديمية
Acalabrutinib-based regimens in frontline or relapsed/refractory higher-risk CLL: pooled analysis of 5 clinical trials.
العنوان: | Acalabrutinib-based regimens in frontline or relapsed/refractory higher-risk CLL: pooled analysis of 5 clinical trials. |
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المؤلفون: | Davids MS; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA., Sharman JP; Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, OR., Ghia P; Division of Experimental Oncology, Università Vita-Salute San Raffaele, Milan, Italy.; Division of Experimental Oncology, IRCCS Ospedale San Raffaele, Milan, Italy., Woyach JA; The Ohio State University Comprehensive Cancer Center, Columbus, OH., Eyre TA; Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom., Jurczak W; Maria Skłodowska-Curie National Research Institute of Oncology, Krakow, Poland., Siddiqi T; City of Hope Comprehensive Cancer Center, Duarte, CA., Miranda P; AstraZeneca, Gaithersburg, MD., Shahkarami M; AstraZeneca, South San Francisco, CA., Butturini A; AstraZeneca, South San Francisco, CA., Emeribe U; AstraZeneca, Gaithersburg, MD., Byrd JC; Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH. |
المصدر: | Blood advances [Blood Adv] 2024 Jul 09; Vol. 8 (13), pp. 3345-3359. |
نوع المنشور: | Journal Article |
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: | Pyrazines*/therapeutic use , Leukemia, Lymphocytic, Chronic, B-Cell*/drug therapy , Leukemia, Lymphocytic, Chronic, B-Cell*/mortality , Benzamides*/therapeutic use, Humans ; Male ; Aged ; Female ; Middle Aged ; Aged, 80 and over ; Adult ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Recurrence ; Clinical Trials as Topic ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antibodies, Monoclonal, Humanized/administration & dosage ; Treatment Outcome |
مستخلص: | Abstract: Before targeted therapies, patients with higher-risk chronic lymphocytic leukemia (CLL), defined as del(17p) and/or TP53 mutation (TP53m), unmutated immunoglobulin heavy chain variable region genes (uIGHV), or complex karyotype (CK), had poorer prognosis with chemoimmunotherapy. Bruton tyrosine kinase inhibitors (BTKis) have demonstrated benefit in higher-risk patient populations with CLL in individual trials. To better understand the impact of the second-generation BTKi acalabrutinib, we pooled data from 5 prospective clinical studies of acalabrutinib as monotherapy or in combination with obinutuzumab (ACE-CL-001, ACE-CL-003, ELEVATE-TN, ELEVATE-RR, and ASCEND) in patients with higher-risk CLL in treatment-naive (TN) or relapsed/refractory (R/R) cohorts. A total of 808 patients were included (TN cohort, n = 320; R/R cohort, n = 488). Median follow-up was 59.1 months (TN cohort) and 44.3 months (R/R cohort); 51.3% and 26.8% of patients in the TN and R/R cohorts, respectively, remained on treatment at last follow-up. In the del(17p)/TP53m, uIGHV, and CK subgroups in the TN cohort, median progression-free survival (PFS) and median overall survival (OS) were not reached (NR). In the del(17p)/TP53m, uIGHV, and CK subgroups in the R/R cohort, median PFS was 38.6 months, 46.9 months, and 38.6 months, respectively, and median OS was 60.6 months, NR, and NR, respectively. The safety profile of acalabrutinib-based therapy in this population was consistent with the known safety profile of acalabrutinib in a broad CLL population. Our analysis demonstrates long-term benefit of acalabrutinib-based regimens in patients with higher-risk CLL, regardless of line of therapy. (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.) |
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المشرفين على المادة: | I42748ELQW (acalabrutinib) 0 (Pyrazines) 0 (Benzamides) 0 (Antibodies, Monoclonal, Humanized) O43472U9X8 (obinutuzumab) |
تواريخ الأحداث: | Date Created: 20240419 Date Completed: 20240626 Latest Revision: 20240720 |
رمز التحديث: | 20240720 |
مُعرف محوري في PubMed: | PMC11255369 |
DOI: | 10.1182/bloodadvances.2023011307 |
PMID: | 38640349 |
قاعدة البيانات: | MEDLINE |
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