(Gerd Altmann, Pixabay)
27 Oct. 2020. Clinical trial results show a strategy that first tests for genomic mutations to guide treatments results in better outcomes for patients with acute myeloid leukemia. Findings from the Beat AML Master Clinical Trial sponsored by the Leukemia and Lymphoma Society, or LLS, in Rye Brook, New York appear in yesterday’s issue of the journal Nature Medicine (paid subscription required).
Acute myeloid leukemia or AML is a cancer of the blood and bone marrow that worsens quickly if left untreated. As the disease develops, bone marrow produces abnormal white blood stem cells called myeloblasts that do not mature into normal functioning white blood cells. The excessive growth of abnormal myeloblasts crowds out healthy white, red, and platelet blood cells, and can spread to other parts of the body. Leukemia and Lymphoma Society says acute myeloid leukemia affects some 21,000 individuals in the U.S. each year, leading to about 10,000 deaths.
Because of the need to start treatment quickly to counteract the rapid spread of AML, most adult patients begin treatments, usually with chemotherapy, as soon as possible after diagnosis. The Beat AML trial is testing a different strategy that first takes a genomic test of the patient’s cancer, returning data on the cell DNA and mutations within seven days. The patients’ physicians then use those data to guide selection of treatments to precisely match the AML’s genomic signature.
The early- and mid-stage clinical trial is enrolling 2,000 participants age 60 and older with AML. The study team is looking primarily at the feasibility of conducting a genomic analysis of patients’ AML within seven days to guide treatment decisions, as well as effects on the clinical response rate of patients to those treatments. Participants in this study receive the genomic test before starting treatment, and then decide to proceed with treatments that match the mutation, or other treatments including standard chemotherapy. Foundation Medicine, a company in Cambridge, Massachusetts providing cancer genomic assessments, performs the tests.
The Nature Medicine paper reports on the nearly 400 patients enrolled in the trial by 30 January 2018. Of the initial 395 participants, 374 or 95 percent were successfully analyzed for genomic properties of their AML within seven days of their diagnosis. Of that sample, 224 participants used the precision medicine strategy from the genomic analysis to guide their treatments, from 11 different therapies. The remaining patients chose the standard chemotherapy — 103 participants, usually a combination of cytarabine and daunorubicin — or opting for pallative care or another clinical trial.
The results show participants selecting the precision medicine treatments guided by genomic testing had lower 30-day mortality and longer overall survivial time than patients selecting standard chemotherapy. Precision medicine participants had a median survival time of 12.8 months compared to 3.9 months for standard chemotherapy recipients.
“The study shows that delaying treatment up to seven days is feasible and safe,” says the paper’s senior author John Byrd, chair of leukemeia research at Ohio State University in an LLS statement, “and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival compared to patients who opted for standard of care.” Byrd adds the study shows that “we can move away from chemotherapy treatment for patients who won’t respond or can’t withstand the harsh effects of the same chemotherapies we’ve been using for 40 years and match them with a treatment better suited for their individual case.”
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- FDA Halts Off-the-Shelf Engineered T-Cell Trial
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