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Patients reporting increased fatigue have a higher hazard of death compared with those who did not after adjusting for covariates.
Limited data exists on the clinical utility of real-world application of patient-reported outcomes (PROs) for patients with acute leukemias or myelodysplastic syndrome (MDS), according to Seiichi Villalona, MD, MA, at the American Society of Hematology (ASH) Annual Meeting & Exposition, held recently in San Diego.
Dr. Villalona was the lead presenter of a study titled, “Patient-Reported Outcome Measures Associated With Overall Survival and Acute Care Use in Patients with Newly Diagnosed Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Acute Lymphoblastic Leukemia.”
While the correlation of PROs with clinical outcomes, such as overall survival (OS) and the use of acute care, has been recognized in patients with solid tumors, these correlations are not well known in patients with hematologic malignancies, Dr. Villalona explained.
Researchers Assessed Characteristics of Baseline PRO Measurements
In patients with newly diagnosed acute myeloid leukemia (AML), the researchers evaluated the characteristics of baseline PRO measurements in MDS or acute lymphoblastic leukemia (ALL) and assessed their link with OS and time to acute care use (TAC).
Dr. Villalona and colleagues conducted a retrospective cohort study that included patients with newly diagnosed ALL, AML, or MDS who received care and completed a baseline PRO survey within 30 days of therapy initiation (N=56, median age of 63 [range 26-79]). The study included more males, non-Hispanic Whites, and patients who received intensive initial therapy.
The researchers defined OS as the time from therapy initiation to the time of death and measured each of the symptom domains of the survey on a 1-5 Likert scale. TAC is expressed as time from initiation of therapy to first unplanned acute care visit (ED visit or unplanned admission). They used the Kaplan-Meier method to measure the OS curves, which were compared using log-rank tests. The researchers used Cox proportional-hazards regression modeling to compare the hazards of death and acute care use between groups.
Majority of Patients Experience Fatigue as Most Frequent Symptom
The study team observed that fatigue was the most commonly reported symptom (n=49, 87.5%, mean score of 2.90/5 (SD 1.30), with 58.9% of patients reporting mild or no symptoms (score <4, n=33) and 28.6% (n=16) describing more severe symptoms (scores> or=4). In terms of anorexia, anxiety, or sadness, most patients experienced mild or no symptoms.
For OS, univariate models for the presence of fatigue, anorexia, anxiety, or sadness were not linked with a significantly higher hazard of death. On multivariate analyses adjusting for age, sex, and treatment intensity, every point increase in fatigue severity is linked with a 41% increased hazard of death (HR 1.41,95% CI,1.03–1.93).
When ranked by fatigue severity (≥4 severe vs <≤mild/no symptoms), patients who reported severe fatigue had a 145% increased hazard of death compared with patients who experienced mild/no fatigue (HR 2.45 (95% CI, 1.07–5.61), after adjusting for the above covariates, respectively. Multivariate analyses for anxiety, anorexia, and sadness were not associated with significant differences, according to Dr. Villalona and colleagues.
A total of 25.0% and 42.9% of patients had at least one unplanned acute care visit within 30 to 90 days from initiation of therapy, respectively, and the median TAC for this cohort was 4.15 months. Univariate regression modeling for any of the PROs assessed revealed no differences. After adjusting for age, sex, and therapy intensity, the study team found no differences in multivariate analyses for each PRO.
“Patients reporting increased fatigue were found to have a higher hazard of death compared [with] those who did not after adjusting for age, sex, and treatment intensity,” Dr. Villalona and colleagues wrote in a statement. “The characteristics and PROs were not associated with TAC or predictive of acute care use at different time points from therapy initiation.” They added that future research is needed to understand how PRO data can be used to identify patients at higher risk before initiating treatment.
