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    Long-term follow-up of MCL patients treated with single-agent ibrutinib: Updated safety and efficacy results.

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    Authors
    Wang, M
    Blum, K
    Martin, P
    Goy, A
    Auer, R
    Kahl, B
    Jurczak, W
    Advani, R
    Romaguera, J
    Williams, M
    Barrientos, J
    Chmielowska, E
    Radford, John A
    Stilgenbauer, S
    Dreyling, M
    Jedrzejczak, W
    Johnson, P
    Spurgeon, S
    Zhang, L
    Baher, L
    Cheng, M
    Lee, D
    Beaupre, D
    Rule, S
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    Affiliation
    The University of Texas MD Anderson Cancer Center, Houston, TX, United States;
    Issue Date
    2015-06-09
    
    Metadata
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    Abstract
    Ibrutinib, an oral inhibitor of Bruton tyrosine kinase, is approved for patients with mantle cell lymphoma (MCL) who have received one prior therapy. Herein, we report the updated safety and efficacy results from the multicenter, open-label phase 2 registration trial of ibrutinib (median 26.7-month follow-up). Patients (N=111) received oral ibrutinib 560 mg once daily, and those with stable disease or better could enter a long-term extension study. The primary end point was overall response rate (ORR). The median patient age was 68 years (range, 40-84) with a median of 3 prior therapies (range, 1-5). The median treatment duration was 8.3 months; 46% of patients were treated for >12 months, and 22% were treated for ≥2 years. The ORR was 67% (23% complete response) with a median duration of response of 17.5 months. The 24-month PFS and OS rates were 31% (95% CI: 22.3-40.4) and 47% (95% CI: 37.1-56.9), respectively. The most common adverse events (AEs) in >30% of patients included diarrhea (54%), fatigue (50%), nausea (33%), and dyspnea (32%). The most frequent grade ≥3 infections included pneumonia (8%), urinary tract infection (4%), and cellulitis (3%). Grade ≥3 bleeding events in ≥2% of patients were hematuria (2%) and subdural hematoma (2%). Common all-grade hematologic AEs were thrombocytopenia (22%), neutropenia (19%), and anemia (18%). The prevalence of infection, diarrhea, and bleeding was highest for the first 6 months of therapy and less thereafter. With longer follow-up, ibrutinib continues to demonstrate durable responses and favorable safety in relapsed/refractory MCL. The trial is registered to www.ClinicalTrials.gov as NCT01236391.
    Citation
    Long-term follow-up of MCL patients treated with single-agent ibrutinib: Updated safety and efficacy results. 2015: Blood
    Journal
    Blood
    URI
    http://hdl.handle.net/10541/560878
    DOI
    10.1182/blood-2015-03-635326
    PubMed ID
    26059948
    Type
    Article
    Language
    en
    ISSN
    1528-0020
    ae974a485f413a2113503eed53cd6c53
    10.1182/blood-2015-03-635326
    Scopus Count
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