Phase 3 randomized trial of chemotherapy with or without oblimersen in older AML patients: CALGB 10201 (Alliance)
| Autor: | Robert K. Stuart, Grerk Sutamtewagul, Ann-Kathrin Eisfeld, Ravi Vij, Krzysztof Mrózek, Jessica Kohlschmidt, Mohan Thakuri, Richard Stone, William Blum, Wendy Stock, Andrew J. Carroll, Jonathan E. Kolitz, Richard A. Larson, Guido Marcucci, Eunice S. Wang, Clara D. Bloomfield, Jun Yin, John C. Byrd, Alison Walker, Sawyer B. Jacobson |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Oncology medicine.medical_specialty Myeloid Clinical Trials and Observations Daunorubicin Chronic lymphocytic leukemia medicine.medical_treatment 03 medical and health sciences 0302 clinical medicine hemic and lymphatic diseases Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans neoplasms Aged Chemotherapy business.industry Oblimersen Cytarabine Hematology Thionucleotides medicine.disease Chemotherapy regimen Leukemia Myeloid Acute Leukemia 030104 developmental biology medicine.anatomical_structure 030220 oncology & carcinogenesis business medicine.drug |
| Zdroj: | Blood Adv |
| ISSN: | 2473-9537 2473-9529 |
| Popis: | Overexpression of B-cell leukemia/lymphoma 2 (BCL2) renders acute myeloid leukemia (AML) cells resistant to chemotherapy and has been associated with unfavorable outcomes. Oblimersen (G3139) is a phosphorothioate 18-mer antisense oligonucleotide directed against the first 6 BCL2 codons. In a phase 1 study of AML patients treated with G3139, cytarabine, and daunorubicin induction with cytarabine consolidation, no antisense-related toxicity was reported, and BCL2 downregulation occurred in patients achieving complete remission. In this phase 3 trial, untreated older AML patients were randomized to cytarabine (100 mg/m2 per day on days 4-10) and daunorubicin (60 mg/m2 per day on days 4-6) followed by cytarabine consolidation (2000 mg/m2 per day on days 4-8) with (arm A) or without (arm B) G3139 (7 mg/m2 per day on days 1-10 [induction] or days 1-8 [consolidation]). A total of 506 patients were enrolled. No differences in toxicity were observed between arms. Estimated overall survival (OS) at 1 year was 43% for arm A and 40% for arm B (1-sided log rank P = .13), with no differences in disease-free (DFS; P = .26) or event-free survival (P = .80). Subgroup analyses showed patients age |
| Databáze: | OpenAIRE |
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