1. 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
- Author
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Barrientos, Jacqueline C, O’Brien, Susan, Brown, Jennifer R, Kay, Neil E, Reddy, Nishitha M, Coutre, Steven, Tam, Constantine, Mulligan, Stephen, Jaeger, Ulrich, Devereux, Stephen, Pocock, Christopher, Robak, Tadeusz, Schuster, Stephen J, Schuh, Anna, Gill, Devinder, Bloor, Adrian, Dearden, Claire, Moreno, Carol, Cull, Gavin, Hamblin, Mike, Jones, Jeffrey A, Eckert, Karl, Solman, Isabelle G, Suzuki, Samuel, Hsu, Emily, James, Danelle F, Byrd, John C, and Hillmen, Peter
- Subjects
Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Orphan Drug ,Lymphoma ,Cancer ,Clinical Trials and Supportive Activities ,Rare Diseases ,Clinical Research ,Hematology ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers ,Erythrocyte Indices ,Female ,Follow-Up Studies ,Humans ,Leukemia ,Lymphocytic ,Chronic ,B-Cell ,Leukocyte Count ,Male ,Patient Acceptance of Health Care ,Patient Reported Outcome Measures ,Quality of Life ,Recurrence ,Symptom Assessment ,Treatment Outcome ,Bruton's tyrosine kinase ,Disease-related symptoms ,Fatigue ,Quality of life ,Relapsed/refractory CLL/SLL ,Clinical Sciences ,Cardiovascular medicine and haematology ,Oncology and carcinogenesis - Abstract
BackgroundIbrutinib 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 methodsMeasures 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.ResultsWith 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.ConclusionIbrutinib 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.
- Published
- 2018