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

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 & 8 others Jeffrey A. Jones, Karl Eckert, Isabelle G. Solman, Samuel Suzuki, Emily Hsu, Danelle F. James, John C. Byrd, Peter Hillmen

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

In the phase III study RESONATE, ibrutinib reduced the risk of progression and improved overall survival versus ofatumumab in previously treated patients with CLL/SLL. In this novel analysis of patient well-being including patient-reported outcomes, ibrutinib reduced disease burden while preserving parameters of hematologic and immunologic function in RESONATE. These results suggest that ibrutinib can improve quality of life while prolonging survival.

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 TherapyeFatigue (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 = 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. (C) 2018 The Authors. Published by Elsevier Inc.

Original languageEnglish
Pages (from-to)803-+
Number of pages18
JournalClinical Lymphoma, Myeloma & Leukemia
Volume18
Issue number12
DOIs
Publication statusPublished - Dec 2018
Externally publishedYes

Cite this

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. / 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. In: Clinical Lymphoma, Myeloma & Leukemia. 2018 ; Vol. 18, No. 12. pp. 803-+.
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abstract = "In the phase III study RESONATE, ibrutinib reduced the risk of progression and improved overall survival versus ofatumumab in previously treated patients with CLL/SLL. In this novel analysis of patient well-being including patient-reported outcomes, ibrutinib reduced disease burden while preserving parameters of hematologic and immunologic function in RESONATE. These results suggest that ibrutinib can improve quality of life while prolonging survival.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 TherapyeFatigue (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 = 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. (C) 2018 The Authors. Published by Elsevier Inc.",
keywords = "Bruton's tyrosine kinase, Disease-related symptoms, Fatigue, Quality of life, Relapsed/refractory CLL/SLL, QUALITY-OF-LIFE, FLUDARABINE PLUS CYCLOPHOSPHAMIDE, INITIAL THERAPY, CHLORAMBUCIL, MULTICENTER, TRIAL",
author = "Barrientos, {Jacqueline C.} and Susan O'Brien and Brown, {Jennifer R.} and Kay, {Neil E.} and Reddy, {Nishitha M.} and Steven Coutre and Constantine Tam and Stephen Mulligan and Ulrich Jaeger and Stephen Devereux and Christopher Pocock and Tadeusz Robak and Schuster, {Stephen J.} and Anna Schuh and Devinder Gill and Adrian Bloor and Claire Dearden and Carol Moreno and Gavin Cull and Mike Hamblin and Jones, {Jeffrey A.} and Karl Eckert and Solman, {Isabelle G.} and Samuel Suzuki and Emily Hsu and James, {Danelle F.} and Byrd, {John C.} and Peter Hillmen",
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Barrientos, JC, O'Brien, S, Brown, JR, Kay, NE, Reddy, NM, Coutre, S, Tam, C, Mulligan, S, Jaeger, U, Devereux, S, Pocock, C, Robak, T, Schuster, SJ, Schuh, A, Gill, D, Bloor, A, Dearden, C, Moreno, C, Cull, G, Hamblin, M, Jones, JA, Eckert, K, Solman, IG, Suzuki, S, Hsu, E, James, DF, Byrd, JC & Hillmen, P 2018, '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' Clinical Lymphoma, Myeloma & Leukemia, vol. 18, no. 12, pp. 803-+. https://doi.org/10.1016/j.clml.2018.08.007

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.; 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.

In: Clinical Lymphoma, Myeloma & Leukemia, Vol. 18, No. 12, 12.2018, p. 803-+.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Barrientos, Jacqueline C.

AU - O'Brien, Susan

AU - Brown, Jennifer R.

AU - Kay, Neil E.

AU - Reddy, Nishitha M.

AU - Coutre, Steven

AU - Tam, Constantine

AU - Mulligan, Stephen

AU - Jaeger, Ulrich

AU - Devereux, Stephen

AU - Pocock, Christopher

AU - Robak, Tadeusz

AU - Schuster, Stephen J.

AU - Schuh, Anna

AU - Gill, Devinder

AU - Bloor, Adrian

AU - Dearden, Claire

AU - Moreno, Carol

AU - Cull, Gavin

AU - Hamblin, Mike

AU - Jones, Jeffrey A.

AU - Eckert, Karl

AU - Solman, Isabelle G.

AU - Suzuki, Samuel

AU - Hsu, Emily

AU - James, Danelle F.

AU - Byrd, John C.

AU - Hillmen, Peter

PY - 2018/12

Y1 - 2018/12

N2 - In the phase III study RESONATE, ibrutinib reduced the risk of progression and improved overall survival versus ofatumumab in previously treated patients with CLL/SLL. In this novel analysis of patient well-being including patient-reported outcomes, ibrutinib reduced disease burden while preserving parameters of hematologic and immunologic function in RESONATE. These results suggest that ibrutinib can improve quality of life while prolonging survival.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 TherapyeFatigue (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 = 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. (C) 2018 The Authors. Published by Elsevier Inc.

AB - In the phase III study RESONATE, ibrutinib reduced the risk of progression and improved overall survival versus ofatumumab in previously treated patients with CLL/SLL. In this novel analysis of patient well-being including patient-reported outcomes, ibrutinib reduced disease burden while preserving parameters of hematologic and immunologic function in RESONATE. These results suggest that ibrutinib can improve quality of life while prolonging survival.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 TherapyeFatigue (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 = 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. (C) 2018 The Authors. Published by Elsevier Inc.

KW - Bruton's tyrosine kinase

KW - Disease-related symptoms

KW - Fatigue

KW - Quality of life

KW - Relapsed/refractory CLL/SLL

KW - QUALITY-OF-LIFE

KW - FLUDARABINE PLUS CYCLOPHOSPHAMIDE

KW - INITIAL THERAPY

KW - CHLORAMBUCIL

KW - MULTICENTER

KW - TRIAL

U2 - 10.1016/j.clml.2018.08.007

DO - 10.1016/j.clml.2018.08.007

M3 - Article

VL - 18

SP - 803-+

JO - Clinical Lymphoma, Myeloma & Leukemia

JF - Clinical Lymphoma, Myeloma & Leukemia

SN - 1526-9655

IS - 12

ER -