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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.


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.

SUBMITTER: Barrientos JC 

PROVIDER: S-EPMC6527106 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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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.

Barrientos Jacqueline C JC   O'Brien Susan S   Brown Jennifer R JR   Kay Neil E NE   Reddy Nishitha M NM   Coutre Steven S   Tam Constantine C   Mulligan Stephen S   Jaeger Ulrich U   Devereux Stephen S   Pocock Christopher C   Robak Tadeusz T   Schuster Stephen J SJ   Schuh Anna A   Gill Devinder D   Bloor Adrian A   Dearden Claire C   Moreno Carol C   Cull Gavin G   Hamblin Mike M   Jones Jeffrey A JA   Eckert Karl K   Solman Isabelle G IG   Suzuki Samuel S   Hsu Emily E   James Danelle F DF   Byrd John C JC   Hillmen Peter P  

Clinical lymphoma, myeloma & leukemia 20180818 12


<h4>Background</h4>Ibrutinib compared with ofatumumab significantly improves progression-free and overall survival in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).<h4>Patients and methods</h4>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 Ass  ...[more]

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