The proposed project will focus on the overall goal of standardizing criteria for decision-making for patients with newly diagnosed acute myeloid leukemia (AML), especially those who are older and medically infirm. Older patients with a relatively high burden of comorbidities are likely excluded from a potentially curative treatment such as hematopoietic cell transplantation (HCT), with this selection bias confounding interpretation of HCT results. The same is likely true for older patients receiving induction therapy for AML since comorbidities have not been assessed at the time of diagnosis of AML for their impact on early mortality, long-term survival, quality of life (QOL), or possibility for allogeneic HCT. To better understand the actual prevalence and role of comorbidities among AML patients, a comprehensive analysis dating from the time of diagnosis is warranted. The proposed research will address three parallel major aims. The first will assess whether comorbidity indices can predict outcomes among newly diagnosed AML patients. Three widely-used indices will be tested; the HCT-comorbidity index (CI), the Charlson comorbidity index (CCI), and the adult comorbidity evaluation-27 (ACE-27) test. A retrospective multicenter protocol will be used to collect data on organ dysfunction from medical records of patients (n=1500), who are newly diagnosed with AML and treated at 4 collaborating institutions over the duration of 4 years. Then, the retrospective patient cohort will be randomly divided into a training (n=1000) and a validation (n=500) set. We will develop and validate a set of criteria, including the comorbidity index, with discriminative capacity for post-treatment mortality. These criteria will be used for individualized decision-making about induction treatment for AML. It seems likely that this approach will steer us away from the current practice in which AML patients are assigned to treatment strictly according to age &lt;60 or ≥60, despite the common observation that some patients in their 60s are healthier than others in their 50s. Whether baseline PFT impairments or high serum ferritin are essential for outcome prediction will be evaluated in a subset of the prospectively enrolled group of patients (n=240). Secondly, we will initiate a multi-center prospective observational study of patients with AML at diagnosis, who will be treated at the Seattle Cancer care Alliance (SCCA), Stanford Cancer Center, Oregon Health & Science University (OHSU), and University of Utah.WE HAVE REQUESTED PERMISSION TO REBUDGET TO PROVIDE NORTHWESTERN AS A SITE. Patients will be enrolled for 3 years. The second aim will examine the feasibility of HCT especially in older and medically infirm patients, who appear to be eligible for reduced intensity HCT because of preliminary results suggesting benefit. We will ask patients about factors influencing their treatment decisions, including consideration of family and physician recommendations, and their values for length of life, QOL, and chance for cure. We will also collect data on baseline QOL, comorbidities, and other factors. We will examine which of these factors are more influential in whether patients proceed to HCT or not. Understanding selection bias, we will follow the prospectively enrolled patients for an additional year and describe their outcomes. The third aim will be to compare outcomes and QOL among older and medically infirm AML patients who were treated with allogeneic HCT versus conventional chemotherapy. These comparisons will be adjusted for the impacts of the outcome-disc
|Effective start/end date||1/1/14 → 6/30/18|
- Fred Hutchinson Cancer Research Center (0000793009 // RSG-13-084-01-CPHPS)
- Patient-Centered Outcomes Research Institute (0000793009 // RSG-13-084-01-CPHPS)
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