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Blood. 2017 Feb 6. pii: blood-2016-10-747345. doi: 10.1182/blood-2016-10-747345. [Epub ahead of print]

Targeting BTK with ibrutinib in relapsed/refractory marginal zone lymphoma.

Author information

  • 1Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, United States; noya@mskcc.org.
  • 2David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.
  • 3APHP, Hopital Saint-Louis, Hemato-oncology Department, Paris Diderot University, Sorbonne Paris-Cite, France.
  • 4Division of Hematology/Oncology, Weill Cornell Medical College, New York, NY, United States.
  • 5Winship Cancer Institute of Emory University, Atlanta, GA, United States.
  • 6Hematologie, Centre Hospitalier Universitaire, Universite de Lille, EA GRIIOT, France.
  • 7Department of Haematology, Oxford University Hospitals NHS Foundation Trust, United Kingdom.
  • 8Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
  • 9Clinical Research Alliance, Center for Lymphoma and Myeloma, Weill Cornell Medical College, New York, NY, United States.
  • 10Florida Cancer Specialists, Atlantis, FL, United States.
  • 11Department of Medicine, Division of Medical Oncology, University of Washington, Seattle, WA, United States.
  • 12Div. of Hematology and Medical Oncology, Dept of Medicine, Hofstra Northwell School of Medicine, Hempstead, NY, United States.
  • 13Pharmacyclics, LLC, an AbbVie Company, Sunnyvale, CA, United States.
  • 14City of Hope National Medical Center, Duarte, CA, United States.

Abstract

Marginal zone lymphoma (MZL) is a heterogeneous B-cell malignancy for which no standard treatment exists. MZL is frequently linked to chronic infection, which may induce B-cell receptor (BCR) signaling resulting in aberrant B-cell survival and proliferation. We conducted a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of ibrutinib in previously treated MZL. Patients with histologically-confirmed MZL of all subtypes who received ≥1 prior therapy with an anti-CD20 antibody-containing regimen were treated with ibrutinib 560 mg orally once daily until progression or unacceptable toxicity. The primary end point was independent review committee-assessed overall response rate (ORR) by 2007 IWG criteria. Among 63 enrolled patients, median age was 66 years (range, 30-92). Median number of prior systemic therapies was 2 (range, 1-9), and 63% received ≥1 prior chemoimmunotherapy. In 60 evaluable patients, ORR was 48% (95% CI, 35-62). With median follow-up of 19.4 months, median duration of response was not reached (95% CI, 16.7-NE), and median progression-free survival was 14.2 months (95% CI, 8.3-NE). Grade ≥3 adverse events (AEs; >5%) included anemia, pneumonia, and fatigue. Serious AEs of any grade occurred in 44%, with grade 3-4 pneumonia being the most common (8%). Rates of discontinuation and dose reductions due to AEs were 17% and 10%, respectively. Single-agent ibrutinib induced durable responses with a favorable benefit-risk profile in patients with previously treated MZL, confirming the role of BCR signaling in this malignancy. Given the lack of approved therapies, ibrutinib may provide a treatment option without chemotherapy for MZL.

PMID:
28167659
DOI:
10.1182/blood-2016-10-747345
[PubMed - as supplied by publisher]
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