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; Coutré, Steven; Tam, Constantine S.; Mulligan, Stephen P.; Jaeger, Ulrich; Devereux, Stephen; Pocock, Christopher; Robak, Tadeusz; Schuster, Stephen J.; Schuh, Anna; Gill, Devinder; Bloor, Adrian; Dearden, Claire; Moreno, Carol; Cull, Gavin; Hamblin, M; Jones, Jeffrey A.; Eckert, Karl; Solman, Isabelle G.; Suzuki, Samuel; Hsu, Emily; James, Danelle F.; Byrd, John C.; Hillmen, Peter

doi:10.1016/j.clml.2018.08.007

Cited by 38 publications

(39 citation statements)

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“…Median platelet count at baseline was 105 (range, 2–310) × 10 9 /l in PCYC‐1102 and 117 (range, 20–441) × 10 9 /l in PCYC‐1112; 45% and 38% of patients, respectively, had platelet count <100 × 10 9 /l and 12% and 11%, respectively, had platelet count <50 × 10 9 /l. In both studies, we observed an increase in platelet count over time (Barrientos et al , ; Byrd et al , ). Concomitant anticoagulation or antiplatelet therapy was common; 35 patients (11%) received anticoagulants, 110 (34%) received antiplatelet agents and 30 (9%) received both (Table , Table SI).…”

Section: Resultssupporting

confidence: 60%

Use of anticoagulants and antiplatelet in patients with chronic lymphocytic leukaemia treated with single‐agent ibrutinib

et al. 2017

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SummaryBleeding events have been observed among a subgroup of chronic lymphocytic leukaemia (CLL) patients treated with ibrutinib. We analysed data from two studies of single‐agent ibrutinib to better characterize bleeding events and pattern of anticoagulation and antiplatelet use. Among 327 ibrutinib‐treated patients, concomitant anticoagulation (11%) or antiplatelet use (34%) was common, but major bleeding was infrequent (2%). Bleeding events were primarily grade 1, and infrequently (1%) led to discontinuation. Among 175 patients receiving concomitant anticoagulant or antiplatelet agents, 5 had major bleeding events (3%). These events were typically observed in conjunction with other factors, such as coexisting medical conditions and/or concurrent medications.

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Section: Resultssupporting

confidence: 60%

Use of anticoagulants and antiplatelet in patients with chronic lymphocytic leukaemia treated with single‐agent ibrutinib

et al. 2017

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“…These results show that changes in clinical stage separate the iwCLL PR/PR‐L response category into different, clinically meaningful, subgroups and reinforces the notion that improving cytopenias is a desirable goal of CLL therapy (Barrientos et al , ). Changes in clinical stage could be a useful and inexpensive method to evaluate treatment response at different time points over the course of the disease.…”

Section: Baseline Characteristics By Binet Staging For Partial Responsupporting

confidence: 81%

Changes in clinical stage identify patients with CLL and different outcome within iwCLL partial response: RESONATE study

et al. 2018

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“…Historically, chemotherapy treatment for hematologic malignancies was associated with significant numbers or severity of AEs and quality-of-life burdens (26,27). Targeted therapies like acalabrutinib have the potential for more favorable AE profiles and are less likely to be associated with quality-of-life decrements (12,28). Our data show that the combination of acalabrutinib plus obinutuzumab did not decrease patients' quality of life.…”

Section: Research Articlementioning

confidence: 70%

Acalabrutinib plus Obinutuzumab in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia

et al. 2020

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Acalabrutinib is a selective irreversible Bruton tyrosine kinase (BTK) inhibitor that does not affect IL2-associated tyrosine kinase or antibody-dependent cellular cytotoxicity, making it an attractive candidate for combination therapy with anti-CD20 antibodies. We investigated acalabrutinib plus obinutuzumab in a phase Ib/II study (NCT02296918) of patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL). Nineteen treatment-naïve and 26 relapsed/refractory patients were treated with acalabrutinib (100 mg twice daily) until progression and obinutuzumab (cycle 1: 100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15; cycles 2-6: 1,000 mg day 1). Grade 3/4 adverse events occurred in 71% of patients. Overall response rates were 95% (treatment-naïve) and 92% (relapsed/refractory). Thirty-two percent of treatment-naïve and 8% of relapsed/refractory patients achieved complete remission. At 36 months, 94% (treatment-naïve) and 88% (relapsed/refractory) were progression free. Acalabrutinib plus obinutuzumab was well tolerated, producing high and durable responses in treatment-naïve and relapsed/refractory CLL. SIGNIFICANCE: Rituximab plus the less selective BTK inhibitor ibrutinib has not shown benefi t in CLL; however, the selective BTK inhibitor acalabrutinib plus the antibody-dependent cellular cytotoxicityenhanced antibody obinutuzumab yielded durable responses that deepened over time in treatmentnaïve and relapsed/refractory CLL, supporting the evaluation of this approach in larger, comparative studies in CLL.

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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: 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.

Cited by 38 publications

References 30 publications

Use of anticoagulants and antiplatelet in patients with chronic lymphocytic leukaemia treated with single‐agent ibrutinib

Use of anticoagulants and antiplatelet in patients with chronic lymphocytic leukaemia treated with single‐agent ibrutinib

Changes in clinical stage identify patients with CLL and different outcome within iwCLL partial response: RESONATE study

Acalabrutinib plus Obinutuzumab in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia

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