دورية أكاديمية
Aspacytarabine for the treatment of patients with AML unfit for intensive chemotherapy: a phase 2 study.
| العنوان: | Aspacytarabine for the treatment of patients with AML unfit for intensive chemotherapy: a phase 2 study. |
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| المؤلفون: | Altman JK; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL., Zuckerman T; Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center, Haifa, Israel., Koprivnikar J; John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ., McCloskey J; John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ., Kota V; Georgia Cancer Center, Augusta University, Augusta, GA., Keng M; University of Virginia Cancer Center-Charlottesville, Charlottesville, VA., Frankfurt O; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL., Abaza Y; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL., Bixby DL; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI., Emadi A; University of Maryland School of Medicine, College Park, MD., Burch M; Baylor Scott & White Research Institute, Dallas, TX., Bhatnagar B; Arthur G James Cancer Hospital Comprehensive Cancer Center, The Ohio State University, Columbus, OH., Luger SM; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA., Percival ME; University of Washington and Fred Hutchinson Cancer Center, Seattle, WA., Wolach O; Department of Hematology, Rabin Medical Center, Petah Tikva, Israel., Craig M; Internal Medicine, Hematology-Oncology, West Virginia University, Morgantown, WV., Ganzel C; Shaare Zedek Medical Center, Jerusalem, Israel., Roboz G; Department of Hematology/Oncology, Weill Cornell Medical College, New York City, NY., Levi I; Soroka University Medical Center, Beersheba, Israel., Gourevitch A; Soroka University Medical Center, Beersheba, Israel., Flaishon L; Biosight Ltd, Tel-Aviv, Israel., Tessler S; Biosight Ltd, Tel-Aviv, Israel., Blumberg C; Biosight Ltd, Tel-Aviv, Israel., Gengrinovitch S; Biosight Ltd, Tel-Aviv, Israel., Ben Yakar R; Biosight Ltd, Tel-Aviv, Israel., Rowe JM; Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.; Shaare Zedek Medical Center, Jerusalem, Israel. |
| المصدر: | Blood advances [Blood Adv] 2023 Dec 26; Vol. 7 (24), pp. 7494-7500. |
| نوع المنشور: | Clinical Trial, Phase II; 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: | Leukemia, Myeloid, Acute*/etiology , Myelodysplastic Syndromes*, Humans ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Cytarabine/adverse effects ; Remission Induction |
| مستخلص: | High-dose cytarabine is associated with gastrointestinal and cerebellar toxicity, precluding its use for older or unfit patients with acute myeloid leukemia (AML). Aspacytarabine, an inactive prodrug of cytarabine, was evaluated as monotherapy in a phase 2b study of patients unfit for intensive chemotherapy (NCT03435848). Sixty-five patients with AML were treated with aspacytarabine 4.5 g/m2 per day (equimolar to 3 g/m2 per day cytarabine) for 6 doses per treatment. The median age was 75 years; 60.6% of patients had de novo AML, 28.8% had AML secondary to myelodysplastic syndrome, and 10.6% had therapy-related AML. Overall, 36.9% achieved complete remission (CR) with full count recovery. CR rates in patients with secondary AML, patients with prior treatment with hypomethylating agents, and patients with TP53 mutation were 26.7%, 25%, and 36%, respectively. Median overall survival was 9 months (range, 6-15.9) and was not reached among responders. Hematologic recovery was observed in all responding patients by day 26 without prolonged cytopenias. Adverse events typically precluding the use of high-dose cytarabine in older or unfit patients were not observed. These data suggest that aspacytarabine may be an effective regimen with a reduction in the attendant toxicities associated with high-dose cytarabine, an important consideration when treating AML and other hematologic disorders that use high-dose cytarabine. This trial was registered at www.clinicaltrials.gov as #NCT03435848. (© 2023 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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| سلسلة جزيئية: | ClinicalTrials.gov NCT03435848 |
| المشرفين على المادة: | 04079A1RDZ (Cytarabine) |
| تواريخ الأحداث: | Date Created: 20231030 Date Completed: 20231216 Latest Revision: 20240110 |
| رمز التحديث: | 20240111 |
| مُعرف محوري في PubMed: | PMC10758705 |
| DOI: | 10.1182/bloodadvances.2023010943 |
| PMID: | 37903324 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 2473-9537 |
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| DOI: | 10.1182/bloodadvances.2023010943 |