Author(s)
Walker P1, Sharman J2, Jurczak W3, Munir T4, Banerji V5, Coutre S6, Woyach J7, Salles G8, Wierda WG9, Patel P10, Wang MH10, Emeribe U11, Flood E11, Byrd JC7, Ghia P12
1Peninsula Health, and Peninsula Private Hospital, LANGWARRIN, VIC, Australia, 2Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA, 3Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, Poland, 4St James's Hospital, Leeds, UK, 5Max Rady Faculty of Health Sciences, College of Medicine at the University of Manitoba, Winnipeg, MB, Canada, 6Stanford University School of Medicine, Stanford, CA, USA, 7The Ohio State University Comprehensive Cancer Center and Division of Hematology, Columbus, OH, USA, 8Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie Clinique, Pierre-Bénite, France, 9The University of Texas MD Anderson Cancer Center, Houston, TX, USA, 10Acerta Pharma, South San Francisco, CA, USA, 11AstraZeneca, Gaithersburg, MD, USA, 12Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy
OBJECTIVES : Report patient-reported outcomes of fatigue and health-related quality of life (HRQoL) from the randomized, phase 3, ELEVATE-TN study (NCT02475681) in patients with treatment-naïve chronic lymphocytic leukemia (CLL). METHODS : Patients received acalabrutinib alone (A), A plus obinutuzumab (AO), or chlorambucil plus obinutuzumab (CO). Assessments included the FACIT-Fatigue Global Fatigue Score (GFS) (scale: 0–52; lower score=worse outcome [clinically meaningful improvement: ≥+3]) and the EORTC QLQ-C30 Global Health Status (GHS) score (scale: 0–100; lower score=worse HRQoL [clinically meaningful improvement: >+8]) in all patients (excluding those who progressed) and those with severe fatigue at baseline (GFS ≤34), analyzed using mixed-model repeated measures methodology. A post-hoc analysis assessed time to clinically meaningful deterioration (TTD; change ≤−3) in GFS. RESULTS : Among 535 randomized patients, 449 completed the GFS (A, n=156; AO, n=152; CO, n=141) and 450 completed the GHS (A, n=157; AO, n=151; CO, n=142) at baseline. Overall, 151 randomized patients had severe fatigue (A, n=56; AO, n=53; CO, n=42); all completed both questionnaires at baseline. In all arms, GFS and GHS improvements were observed by week 4 (mean changes: 2.76 and 5.35 for A [n=136, n=137], 2.33 and 2.17 for AO [n=138, n=138], 1.26 and 2.53 for CO [n=121, n=122]) and maintained at 96 weeks (4.94 and 7.01 for A [n=81, n=82], 3.91 and 5.25 for AO [n=92, n=92], 3.86 and 2.41 for CO [n=38, n=38]); this benefit was larger in patients with severe fatigue. Median TTD in fatigue was longer in acalabrutinib-containing arms (A: 16.9 mo; AO: 16.7 mo) versus CO (5.7 mo [P=0.0376 vs A; P=0.1596 vs AO]). CONCLUSIONS : In ELEVATE-TN, all treatments improved fatigue scores; TTD of fatigue was significantly longer with acalabrutinib-containing treatment. The previously reported statistically significant progression-free survival increases with A/AO versus CO (Lancet. 2020;395:1278-91) were accompanied by clinically meaningful HRQoL benefits.
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Acceptance Code
CN4
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Drugs, Oncology
