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Is There a Less-Toxic Treatment Alternative to Intensive Chemotherapy for Patients With AML?

By: Gavin Calabretta, BS
Posted: Wednesday, November 10, 2021

New findings from a retrospective study published in Cancer suggest that 10-day treatment of relapsed acute myeloid leukemia (AML) with decitabine and venetoclax (DEC10-VEN) yields comparable results to traditional intensive chemotherapy. According to Marina Y. Konopleva, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues, the experimental treatment was compared with multiple intensive chemotherapy-based regimens, including idarubicin with cytarabine, with or without cladribine, clofarabine, fludarabine, and other agents.

“Treatment-related toxicities are considerable barriers to treatment and limit the testing of novel agents because of the risk of additive toxicity,” the study authors explained. “Venetoclax-based lower-intensity regimens have been a paradigm-shifting development in the field because of modest end-organ toxicity apart from myelosuppression and resultant infections.”

The study consisted of a 65-patient cohort receiving the DEC10-VEN regimen and a cohort of 130 patients who were all treated with intensive chemotherapy. The median ages for the two groups were 64 and 58 years, respectively, and individuals with an Eastern Cooperative Oncology Group performance status greater than three were excluded from the study.

DEC10-VEN resulted in significantly higher responses including a higher overall response rate (60% vs. 36%; odds ratio [OR] = 3.28; P < .001), complete remission with incomplete hematologic recovery (19% vs. 6%; OR = 3.56; P = .012), and minimal residual disease negativity by flow cytometry (28% vs. 13%; OR = 2.48; P = .017). Median event-free survival and median overall survival were significantly longer in the DEC10-VEN cohort. In addition, multivariate analysis revealed that DEC10-VEN was independently associated with improved overall survival compared with intensive chemotherapy.

The authors have since initiated two phase II trials of 5- and 10-day regimens of decitabine/cedazuridine with venetoclax to further study the agent.

Disclosure: For full disclosures of the study authors, visit acsjournals.onlinelibrary.wiley.com.



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