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Type: Journal article
Title: Venetoclax combined with low-dose cytarabine for previously untreated patients with acute myeloid leukemia: results from a Phase Ib/II study
Author: Wei, A.
Strickland, S.
Hou, J.
Fiedler, W.
Lin, T.
Walter, R.
Enjeti, A.
Tiong, I.
Savona, M.
Lee, S.
Chyla, B.
Popovic, R.
Salem, A.
Agarwal, S.
Xu, T.
Fakouhi, K.
Humerickhouse, R.
Hong, W.
Hayslip, J.
Roboz, G.
Citation: Journal of Clinical Oncology, 2019; 37(15):1277-1284
Publisher: American Society of Clinical Oncology
Issue Date: 2019
ISSN: 0732-183X
Statement of
Andrew H. Wei, Stephen A. Strickland Jr, Jing-Zhou Hou, Walter Fiedler, Tara L. Lin, Roland B. Walter, Anoop Enjeti, Ing Soo Tiong, Michael Savona, Sangmin Lee, Brenda Chyla, Relja Popovic, Ahmed Hamed Salem, Suresh Agarwal, Tu Xu, Kaffa M. Fakouhi, Rod Humerickhouse, Wan-Jen Hong, John Hayslip and Gail J. Roboz
Abstract: Purpose: Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. An international phase Ib/II study evaluated the safety and preliminary efficacy of venetoclax, a selective B-cell leukemia/lymphoma-2 inhibitor, together with low-dose cytarabine (LDAC) in older adults with AML. Patients and Methods: Adults 60 years or older with previously untreated AML ineligible for intensive chemotherapy were enrolled. Prior treatment of myelodysplastic syndrome, including hypomethylating agents (HMA), was permitted. Eighty-two patients were treated at the recommended phase II dose: venetoclax 600 mg per day orally in 28-day cycles, with LDAC (20 mg/m2 per day) administered subcutaneously on days 1 to 10. Key end points were tolerability, safety, response rates, duration of response (DOR), and overall survival (OS). Results: Median age was 74 years (range, 63 to 90 years), 49% had secondary AML, 29% had prior HMA treatment, and 32% had poor-risk cytogenetic features. Common grade 3 or greater adverse events were febrile neutropenia (42%), thrombocytopenia (38%), and WBC count decreased (34%). Early (30-day) mortality was 6%. Fifty-four percent achieved complete remission (CR)/CR with incomplete blood count recovery (median time to first response, 1.4 months). The median OS was 10.1 months (95% CI, 5.7 to 14.2), and median DOR was 8.1 months (95% CI, 5.3 to 14.9 months). Among patients without prior HMA exposure, CR/CR with incomplete blood count recovery was achieved in 62%, median DOR was 14.8 months (95% CI, 5.5 months to not reached), and median OS was 13.5 months (95% CI, 7.0 to 18.4 months). Conclusion: Venetoclax plus LDAC has a manageable safety profile, producing rapid and durable remissions in older adults with AML ineligible for intensive chemotherapy. High remission rate and low early mortality combined with rapid and durable remission make venetoclax and LDAC an attractive and novel treatment for older adults not suitable for intensive chemotherapy.
Keywords: Humans
Antineoplastic Combined Chemotherapy Protocols
Age Factors
Aged, 80 and over
Middle Aged
Leukemia, Myeloid, Acute
Bridged Bicyclo Compounds, Heterocyclic
Rights: Copyright © 2019 American Society of Clinical Oncology. All rights reserved. Creative Commons Attribution Non-Commercial No Derivatives 4.0 License
DOI: 10.1200/JCO.18.01600
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