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
Year: 2018
Type: article
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). 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. 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. 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.
Authors: Jacqueline C. Barrientos, Susan O’Brien, Jennifer R. Brown, Neil E. Kay, Nishitha M. Reddy, Steven Coutre, Constantine Tam, Stephen Mulligan, Ulrich Jaeger, Stephen Devereux, Christopher Pocock, Tadeusz Robak, Stephen J. Schuster, Anna Schuh, Devinder Gill, Adrian Bloor, Claire Dearden, Carol Moreno, Gavin Cull, Mike Hamblin, Jeffrey A. Jones, Karl Eckert, Isabelle G. Solman, Samuel Suzuki, Emily Hsu, Danelle F. James, John C. Byrd, Peter Hillmen
Institutions: Hofstra University, Donald & Barbara Zucker School of Medicine at Hofstra/Northwell, University of California, Irvine, Dana-Farber Cancer Institute, Mayo Clinic, Vanderbilt University, Vanderbilt-Ingram Cancer Center, Stanford Medicine, Stanford University, Peter MacCallum Cancer Centre, St Vincent's Hospital Melbourne, The University of Sydney, Royal North Shore Hospital, Medical University of Vienna, King's College Hospital NHS Foundation Trust, King's College Hospital, East Kent Hospitals University NHS Foundation Trust, Medical University of Lodz, National Institute for Health and Care Research, University of Oxford, Princess Alexandra Hospital, The Christie Hospital, Royal Marsden NHS Foundation Trust, Royal Marsden Hospital, Hospital de Sant Pau, Sir Charles Gairdner Hospital, Colchester Hospital, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Pharmacyclics (United States), St James's University Hospital
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,890
OpenAlex ID: W2887344706