Patient-Reported Disease Burden in the Elderly Patients with Acute Myeloid Leukemia

Background Acute Myeloid Leukemia (AML) is the most aggressive type of leukemia and is associated with poor overall survival (OS), particularly in older patients. In this study, we evaluated physical, psychological and social functions in a cohort of AML patients who were not considered as eligible for standard chemotherapy.

Methods DACO-016 is a randomized phase 3 trial of decitabine versus physician's choice of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed AML who were considered as unfit for intensive chemotherapy. This post hoc analysis evaluated disease burden reported by patients from The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC-QLQ-C30) in 485 elderly patients at baseline. EORTC-QLQ-C30 was reported as five functional scales (physical, role, emotional, social and cognitive), three symptom scales (fatigue, nausea & vomiting and pain), a global health status/Health-Related Quality of Life (HRQoL) scale and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). We compared summary statistics from the EORTC-QLQ-C30 to the EORTC reference values of all cancer patients with age ≥70 yrs. Furthermore, we analyzed the EORTC-QLQ-C30 subscales and sign and symptom scales by ECOG performance status score.

Results Patients (n=454) at baseline were 59.7% male, 86.3% white (Caucasian) with a mean age of 73.2 years; a median of 73 years and interquartile range (69-77). The distribution of ECOG performance status scores of 0, 1 and 2 was 18.1%, 55.7% and 26.2%, respectively. 6.4% of patients were missing baseline EORTC-QLQ-C30 measures. The mean physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning, global health status at baseline scores were 67.6, 62.1, 77.9, 71.6, 68.6 and 50.1, respectively. The mean physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning, global health status at baseline scores for age ≥70 years were 66.9, 61.4, 76.9, 72.2, 68.8 and 50.3, respectively. The results were generally lower than the reference values (Table 1). With increasing ECOG performance status scores, the EORTC-QLQ-C30 health subscales and sign and symptom scales deteriorated. For example, the mean physical functioning scores for ECOG PS 0, 1 and 2 were 80.9, 69.4 and 64.4, respectively.

Conclusion: To our knowledge, this is the largest study to report that the HRQoL of AML patients unfit for intensive chemotherapy is worse than that of the population norm of cancer patients in a similar age-group. This highlights the need for new therapies with less detrimental effect to AML patients.

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