OBJECTIVE: The MD Anderson Symptom Inventory for Acute Myeloid Leukemia and Myelodysplastic Syndrome (MDASI-AML/MDS) is a valid and reliable multisymptom patient-reported outcome (PRO) measure of symptom burden in patients with AML or MDS. Symptom burden is the impact of the severity of disease- and treatment-related symptoms on a patient's functional ability. The purpose of this study was to test the sensitivity of the MDASI-AML/MDS in patients with AML undergoing remission induction therapy (RIT).
MATERIALS AND METHODS: This is a secondary analysis of data from a study to assess the association of inflammation with symptom burden in patients with AML. The MDASI-AML/MDS was administered to patients prior to the start of RIT and weekly thereafter until hospital discharge. Patients rated the severity of 19 symptoms and 6 areas of symptom interference with daily activities on a scale of 0 (symptom not present or no interference) to 10 (symptom severity as bad as you can imagine or complete interference) at their worst in the last 24 hours. Descriptive statistics and linear mixed modeling were used to evaluate the sensitivity of the MDASI-AML/MDS.
RESULTS: Patient characteristics are shown in Table 1. A total of 104 evaluable patients who received RIT between September 2013 and August 2015 were included in the analysis. We restricted the analysis to the time from baseline to 4 weeks after the start of RIT because after that time more than one-third of patients were no longer completing the MDASI-AML/MDS, primarily because they had been discharged from the hospital. Average age at baseline assessment was 55.0 years (standard deviation [SD] = 16.40), 54% (56/104) were male, 66% (69/104) received high-intensity RIT, mean time from diagnosis to first assessment was 10.5 days (SD = 42.77).
Symptom and interference ratings are shown in Table 2. The 5 most severe symptoms (mean, SD) at baseline were fatigue (4.2, 3.08), disturbed sleep (3.6, 2.88), drowsiness (3.2, 2.90), distress (3.1, 3.03), and dry mouth (3.0, 3.25). Four weeks after the start of RIT, the 5 most severe symptoms were fatigue (2.9, 3.22), pain (2.5, 3.34), drowsiness (2.2, 2.99), disturbed sleep (2.2, 2.67), and dry mouth (2.1, 2.79). Linear mixed modeling showed that the severity of 11 of the 19 MDASI-AML/MDS symptoms improved significantly (p < 0.05) by 4 weeks post-RIT. Symptom interference with general activities, mood, walking, and enjoyment of life decreased significantly (p < 0.05) from baseline to 4 weeks after the start of RIT.
CONCLUSIONS: The MDASI-AML/MDS was sensitive to changes in symptoms and symptom interference with activities over time in patients with AML undergoing either high-intensity or low-intensity RIT, demonstrating that symptom burden improved significantly after RIT. Patients reported significantly lower severity of most symptoms and less interference with daily activities from symptoms at 4 weeks after the start of RIT than they reported at baseline. The MDASI-AML/MDS is sensitive to improvement in symptom burden in patients with AML following RIT and can be useful in both research and practice for monitoring patient symptomatic response during treatment. The MDASI-AML/MDS is the only validated PRO measure specific to symptom burden in AML.
Williams: Bayer: Research Funding; Bristol-Meyers Squibb: Research Funding; Genentech: Research Funding; Merck: Research Funding; Astra-Zeneca: Research Funding; Pled Pharma: Consultancy. Chen:Merck: Other: Internship. Kontoyiannis:Astellas Pharmaceuticals: Research Funding. Heijnen:Acetylon Pharmaceuticals: Research Funding. Shi:AstraZeneca: Research Funding; Bayer: Research Funding; Bristol-Meyers Squibb: Research Funding; Genentech: Research Funding; Merck: Research Funding.