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Rebecca Olin, MD, MS


Older Patients, Newly Diagnosed AML: Venetoclax-Based Combination Therapy

By: Celeste L. Dixon
Posted: Tuesday, January 26, 2021

After about 1 year of follow-up, a relatively low-intensity regimen of cladribine plus low-dose cytarabine plus venetoclax, alternating with 5-azacitidine plus venetoclax, appears to be effective in treating older patients with newly diagnosed acute myeloid leukemia (AML). It was also reported to be well tolerated, according to Tapan M. Kadia, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. Of 48 patients (mean age, 68), 77% achieved complete remission, and 17% had a complete remission with incomplete blood cell count recovery, according to the results of the phase II trial presented during the virtual edition of the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 25) and published in the journal Blood.

Patients responded after a median of one cycle of treatment. Of the 45 patients who responded, 11 proceeded with allogeneic stem cell transplant. After a median of more than 11 months of follow-up, the median overall survival for the 48-patient cohort had not been reached, with 6- and 12-month overall survival rates of 86% and 70%, respectively. Of the 48 patients, 12 had secondary AML, and 12 had an adverse karyotype. Of those with secondary versus de novo AML, median overall survival was 10.6 months versus not reached, respectively (P = .09). Among those with secondary AML or an adverse karyotype, the complete remission/complete remission with incomplete blood cell count recovery rates were 83% (58%/25%) and 83% (50%/33%), respectively. The most frequent grade 3 or 4 nonhematologic adverse events were neutropenic fever, lung infection, and decreased urine output.

The rates of overall and relapse-free survival “are encouraging in this cohort of older AML patients,” noted Dr. Kadia and colleagues, with the regimen “producing high rates of durable minimal residual disease–negative remission and meaningful blood count recovery. [As such], further study of this backbone in combination approaches is warranted.”

Disclosure: The study authors’ disclosure information can be found at

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