Health-related quality of life in patients with Waldenstrom macroglobulinemia: results from the ASPEN trial.
No Thumbnail Available
All Authors
Tedeschi, A.
Tam, CS.
Owen, RG.
Buske, C.
Leblond, V.
Dimopoulos, M.
Garcia-Sanz, R.
Castillo, JJ.
Trotman, J.
Treon, SP.
LTHT Author
Owen, Roger
LTHT Department
Haematology
Non Medic
Publication Date
2024
Item Type
Journal Article
Randomized Controlled Trial
Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Clinical Trial, Phase III
Multicenter Study
Language
Subject
Subject Headings
Abstract
Aim ASPEN is a randomized, open-label, Phase III study comparing zanubrutinib and ibrutinib in patients with Waldenstrom macroglobulinemia (WM). Materials & methods: Patient-reported outcomes were exploratory end points assessed using the EORTC QLQ-C30 and EQ-5D-5L VAS scores. Results: Overall, 201 patients (102 zanubrutinib; 99 ibrutinib) were enrolled. Clinically meaningful differences were observed in diarrhea and nausea/vomiting in both the intent-to-treat population and in patients attaining very good partial response (VGPR) in earlier cycles of treatment, as well as in long-term physical functioning and fatigue in patients achieving VGPR. Conclusion: Treatment with zanubrutinib was associated with greater improvements in health-related quality of life compared with ibrutinib in patients with WM and MYD88 mutations. Clinical Trial Registration: NCT03053440 (ClinicalTrials.gov).
Journal
Future Oncology