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Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma
- Source :
- Blood. 129:2224-2232
- Publication Year :
- 2017
- Publisher :
- American Society of Hematology, 2017.
-
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 560 mg ibrutinib orally once daily until progression or unacceptable toxicity. The primary end point was independent review committee–assessed overall response rate (ORR) by 2007 International Working Group 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% confidence interval [CI], 35-62). With median follow-up of 19.4 months, median duration of response was not reached (95% CI, 16.7 to not estimable), and median progression-free survival was 14.2 months (95% CI, 8.3 to not estimable). 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. As the only approved therapy, ibrutinib provides a treatment option without chemotherapy for MZL. This study is registered at www.clinicaltrials.gov as #NCT01980628.
- Subjects :
- Male
0301 basic medicine
medicine.medical_treatment
Phases of clinical research
Biochemistry
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Piperidines
Recurrence
Agammaglobulinaemia Tyrosine Kinase
Medicine
Fatigue
Aged, 80 and over
B-Lymphocytes
Standard treatment
Anemia
Hematology
Middle Aged
Protein-Tyrosine Kinases
Chemotherapy regimen
030220 oncology & carcinogenesis
Ibrutinib
Female
Immunotherapy
Adult
medicine.medical_specialty
Immunology
Antineoplastic Agents
Disease-Free Survival
Drug Administration Schedule
03 medical and health sciences
Chemoimmunotherapy
Internal medicine
Humans
Protein Kinase Inhibitors
Aged
Chemotherapy
business.industry
Adenine
Lymphoma, B-Cell, Marginal Zone
Pneumonia
Cell Biology
medicine.disease
Surgery
Regimen
Pyrimidines
030104 developmental biology
chemistry
Pyrazoles
Marginal zone B-cell lymphoma
business
Subjects
Details
- ISSN :
- 15280020 and 00064971
- Volume :
- 129
- Database :
- OpenAIRE
- Journal :
- Blood
- Accession number :
- edsair.doi.dedup.....3d6e2bf12e2ffeec9546e5e2af7ae953