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Improvement in Parameters of Hematologic and Immunologic Function and Patient Well-being in the Phase III RESONATE Study of Ibrutinib Versus Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
- Source :
-
Clinical lymphoma, myeloma & leukemia [Clin Lymphoma Myeloma Leuk] 2018 Dec; Vol. 18 (12), pp. 803-813.e7. Date of Electronic Publication: 2018 Aug 18. - Publication Year :
- 2018
-
Abstract
- Background: Ibrutinib compared with ofatumumab significantly improves progression-free and overall survival in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).<br />Patients and Methods: Measures of well-being were assessed in RESONATE, where previously treated patients with CLL/SLL were randomized to receive ibrutinib 420 mg/day (n = 195) or ofatumumab (n = 196) for up to 24 weeks. Endpoints included hematologic function, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), disease-related symptoms, European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC QLQ-C30), and medical resource utilization.<br />Results: With up to 24 months' follow-up (median, 16.4 months), 79% of cytopenic patients showed sustained hematologic improvement (82% with improved platelet count, 69% with improved hemoglobin) on ibrutinib versus 43% on ofatumumab (P < .0001). Higher rates of clinically meaningful improvement were demonstrated with ibrutinib versus ofatumumab for FACIT-F and EORTC global health. Greater improvement was observed in disease-related weight loss, fatigue, night sweats, and abdominal discomfort with ibrutinib versus ofatumumab. Hospitalizations in the first 30 days occurred less frequently with ibrutinib than ofatumumab (0.087 vs. 0.184 events/patient; P = .0198). New-onset diarrhea was infrequent with ibrutinib after the first 6 months (47% at ≤6 months vs. 5% at 12-18 months). With ibrutinib, grade ≥ 3 hypertension occurred in 6%, grade ≥ 3 atrial fibrillation in 4%, major hemorrhage in 2%, and tumor lysis syndrome in 1% of patients.<br />Conclusion: Ibrutinib led to significant improvements in hematologic function and disease symptomatology versus ofatumumab, and can restore quality of life while prolonging survival in relapsed/refractory CLL/SLL.<br /> (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Antineoplastic Combined Chemotherapy Protocols adverse effects
Biomarkers
Erythrocyte Indices
Female
Follow-Up Studies
Humans
Leukemia, Lymphocytic, Chronic, B-Cell diagnosis
Leukemia, Lymphocytic, Chronic, B-Cell epidemiology
Leukocyte Count
Male
Patient Acceptance of Health Care
Patient Reported Outcome Measures
Quality of Life
Recurrence
Symptom Assessment
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Leukemia, Lymphocytic, Chronic, B-Cell blood
Leukemia, Lymphocytic, Chronic, B-Cell drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 2152-2669
- Volume :
- 18
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Clinical lymphoma, myeloma & leukemia
- Publication Type :
- Academic Journal
- Accession number :
- 30249389
- Full Text :
- https://doi.org/10.1016/j.clml.2018.08.007