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Beat AML Clinical Trial: A Paradigm Shift in Treatment

Dr. Tara Lin

October 26, 2020

Patients participating in The Leukemia & Lymphoma Society’s (LLS) precision medicine Beat AML Master Clinical Trial had superior outcomes compared to acute myeloid leukemia (AML) patients who opted for standard chemotherapy treatment, according to findings published in the prestigious Nature Medicine journal.

The Beat AML trial achieved its primary endpoint by showing genomic analysis of the leukemia cells to identify AML subtypes can be completed within an unprecedented seven days, giving patients, caregivers and their doctors ample time to make a more personalized treatment decision without risking the patient’s chance for survival.

In other key findings, the study demonstrated a fundamental change in how patients diagnosed with AML should be treated, proving that using genetic information to match patients to targeted therapies leads to better survival rates than the traditional one-size-fits all treatment approach.

“It really represents a paradigm shift and changes the way we approach newly diagnosed, older patients with AML.  It makes sense to learn more about a patient’s leukemia and use that biological information to choose the best treatment, and now this study has given us the proof,” said Tara Lin, MD, director of KU Cancer Center’s Acute Leukemia Program and medical director of the Clinical Trials Office.

AML is an extremely fast-moving cancer of the marrow and blood. Only about one in four AML patients survives five years after diagnosis. For decades patients have been given the same treatments almost immediately upon diagnosis because waiting allows the cancer cells to grow out of control. This standard of care involves either infusion of a combination of two chemotherapies, cytarabine and daunorubicin, or treatment with a so-called hypomethylating agent, a drug that unleashes signals allowing the cancer cells to die.

“The study shows that delaying treatment up to seven days is feasible and safe, 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,” said John C. Byrd, MD, D. Warren Brown Chair of Leukemia Research of The Ohio State University, corresponding author of the study, in a press release issued by LLS. “This patient-centric 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.”

LLS launched this clinical trial in fall 2016 to test multiple novel targeted therapies at major cancer centers across the U.S., including KU Cancer Center, in newly diagnosed AML patients aged 60 and older. To date, the trial, which is ongoing, has screened more than 1,000 patients at 16 cancer centers.

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