Audio Journal of Oncology
Reporting from 2018 annual meeting of the American Society of Hematology
SAN DIEGO—Individualized therapy decisions that are founded on “genomic fingerprint” data can now be made within seven days for most patients with suspected diagnoses of acute myeloid leukemia (AML) according to findings from the “Beat AML Umbrella Study for Previously Untreated AML” reported at the 2018 annual meeting of the American Society of Hematology (ASH). The research investigated the use of an algorithm combining data from clinical study evidence from trials with a range of targeted therapies. https://ashpublications.org/blood/article/132/Supplement%201/559/263190/Initial-Report-of-the-Beat-AML-Umbrella-Study-for
“I think it will be a huge paradigm shift for how AML is treated. We’ve really pushed the technology to its edge,” said study author Amy Burd PhD, of the Leukemia and Lymphoma Society, White Plains NY, at an ASH press briefing.
Being able to make treatment decisions within the seven-day period of time was becoming closer to the desired “real time” ability to make these decisions, she told the Audio Journal of Oncology. “With the number of targeted therapies that have been approved it provides the opportunity for doctors to make better choices for their patients.”
The study demonstrated that the algorithm was reducing the time taken for decision making in a disease that required prompt treatment, said Burd. The algorithm had used data on 11 out of the 12 prominent sub-types of mutations characterizing different forms of AML—including such molecular features as TP53, FLT3, IDH1, IDH2, core binding factor and NPM1.
She said the analysis achieved by the algorithm combined three different commercially available diagnostic assays. “We’ve been able to make assignments within the seven day period of time for over 95 per cent of the patients—achieving our primary endpoint of the study,” she said.
The Chief Medical Officer for the Beat AML Trial, John C. Byrd MD, Chair of Leukemia Research and Senior Advisor for Cancer Experimental Therapeutics at Ohio State University Comprehensive Cancer Center, Columbus OH, said that for many years acute myeloid leukemia—the most common adult leukemia—had been treated as a single disease but that science had prompted their study. “What all of the basic science has taught us is that AML is not a single disease but, likely, 15 or more diseases.”
Byrd said that in adults AML was characterized by so-called “driver mutations”—molecules that lead the bone marrow to perform abnormally. “Patients with AML will often have several of these—but one that’s dominant, and several that come later,” he said. “The significance of our trial is that we are looking at the different types of AML and prospectively picking the best therapy for the individual patient in a timely fashion.”
Dominant molecular driver
When he was asked about the diagnostic algorithm they had used in the study he said it had been based on the principle of looking for the dominant driver of the AML. “Do we have a therapy that’s going to be impactful for the biology? And do the patients fall into a small subgroup of patients where what we were doing before—chemotherapy—is really beneficial to them? If the standard is going to help patients we go with that,” he said, noting that the targeted therapies now offered options for the others.
Byrd likened targeting the dominant driver molecule as similar to cutting the trunk of a tree—all the branches die with the tree. “The benefits of the study are that patients are allowed to take advantage of all the technologies we have to pick the best therapy,” he said.
In the seven-day diagnostic time period this individualized approach allowed patients to become accommodated with their disease and avoid hazards such as post traumatic stress disorder from being rushed into therapy without being an active participant in the decision to treat their disease, he noted.
“This is the beginning. But it’s very exciting that we have been able to show that we can effectively assign therapy to more than 95 per cent of patients within seven days,” he said. “Precision medicine is here. And as new therapies come forward for AML we really need to be adopting this approach.”