Abstract
Background: Objectives were to describe guardian proxy-reported quality of life (QoL) during chemotherapy for pediatric acute myeloid leukemia (AML) and to identify treatment and demographic factors associated with worse QoL.
Methods: Children's Oncology Group phase 3 AAML1031 study was a randomized trial for de novo AML patients age 0-30 to receive standard AML therapy with and without bortezomib. Patients with high risk FLT3-internal tandem duplication high allelic ratio (ITD HAR) were allocated to receive sorafenib in addition to the standard chemotherapy. Patients enrolled on the AAML1031 study who were 2-18 years of age at diagnosis with English or Spanish-speaking guardians were eligible to participate in the QoL portion of the study which included the PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module and PedsQL Multidimensional Fatigue Scale. QoL assessments were obtained at four timepoints - at diagnosis and following completion of second, third and fourth (final) course of therapy. Guardians provided proxy assessments for all patients, while self-report for patients 5 years of age or older who could understand English was optional. This analysis focused on guardian proxy-reported QoL for patients who did not have FLT3-ITD HAR. In addition to demographic and treatment related factors, the total number of non-hematological grade 3-4 CTCAE (Common Terminology Criteria for Adverse Events) toxicities occurring during the time frame of QoL assessments was examined as a potential predictor of QoL.
Results: There were a total of 4105 QoL submissions and there were 3513 non-hematological grade 3-4 CTCAE toxicities reported: 1339 submissions at diagnosis with 1088 toxicities reported, 1112 submissions following the second course with 721 toxicities, 929 submissions following third course with 911 toxicities, and 725 submissions following the fourth course with 793 toxicities.
In repeated measures linear regression the number of submitted CTCAE toxicities was significantly associated with worse physical health (β±standard error (SE) -3.00±0.69; P<0.001) and general fatigue (β±SE -2.50±0.66; P<0.001). Older age was significantly associated with general fatigue (β±SE -0.58±0.25; P=0.022). In contrast, gender, risk status, bortezomib assignment, duration of neutropenia, private insurance status, white race and Hispanic ethnicity were not associated with physical health, psychosocial health or fatigue.
Conclusions: The number of CTCAE toxicities was an important factor influencing physical QoL and fatigue among children on treatment for AML. Identifying novel approaches for reducing toxicities should be a priority to potentially improve QoL.
Disclosures
No relevant conflicts of interest to declare.
Multimerin-1 (MMRN1) as Novel Adverse Marker in Pediatric Acute Myeloid Leukemia: A Report from the Children's Oncology Group
