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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.

  • Author(s): 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
  • Hillmen, Peter
  • et al.
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.

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