Stratification of cytarabine treatment for patients with Acute Myeloid Leukemia

For the 2,900 patients per year in the UK diagnosed with Acute Myeloid Leukemia (AML), aggressive cytarabine based chemotherapy is given at diagnosis, yet, up to 40% of patients do not respond to this treatment. The majority of AML patients are >60 years old and, with the rise in the elderly population, increased prevalence of the disease is predicted. Currently, patients in this age range who are deemed fit for treatment are prescribed cytarabine, where outcome to the drug regimen is uninformed and is based on a trial-and-error approach. A rapid and highly accurate stratification-based approach would enable patients with drug responsive cancer to be treated with lower drug doses, reducing acute and long-term side-effects, including the need for antimicrobials and blood product support and future risk of secondary cancers. In order to add economic value and provide a stratified based treatment regimen, clinicians need assistance in selecting the best treatment and care for patients as early as possible. We provide a solution to this clinical problem by offering a rapid, in vitro assay, using a bioluminescent bacterial biosensor, determining patient response to cytarabine with a AUROC value of 0.8. The technology is reliable, robust and enables stratification to identify patients who will benefit from chemotherapeutic treatment, particularly at diagnosis. The aim of this project is to enable engagement with a Diagnostic Evidence Cooperative to provide an economic analysis of this test providing evidence to demonstrate its value for inclusion in routine practice and to work toward best methods of introducing the test into the clinical pathway.