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Blood ; 121(8): 1296-303, 2013 Feb 21.
Article in English | MEDLINE | ID: mdl-23287861

ABSTRACT

The present study aimed to determine the safety and activity of the histone deacetylase inhibitor panobinostat in patients with relapsed/refractory Waldenström macroglobulinemia (WM). Eligibility criteria included patients with relapsed/refractory WM with any number of prior therapies. Patients received panobinostat at 30 mg 3 times a week; 12 of 36 (33%) patients were enrolled at 25 mg dose. A total of 36 patients received therapy. The median age was 62 years (range, 47-80) and the median number of prior therapies was 3 (range, 1-8). All of the patients had received prior rituximab. Minimal response (MR) or better was achieved in 47% of patients (90% confidence interval [CI], 33-62), with 22% partial remissions and 25% MR. In addition, 18 (50%) patients achieved stable disease and none showed progression while on therapy. The median time to first response was 1.8 months (range, 1.7-3.2). The median progression-free survival was 6.6 months(90% CI, 5.5-14.8). Grade 3 and 4 toxicities included thrombocytopenia (67%), neutropenia (36%), anemia (28%), leukopenia (22%), and fatigue (11%). We conclude that panobinostat is an active therapeutic agent in patients with relapsed/ refractory WM. This study (www.clinicaltrials.gov identifier: NCT00936611) establishes a role for histone deacetylase inhibitors as an active class of therapeutic agents in WM.


Subject(s)
Histone Deacetylase Inhibitors/administration & dosage , Hydroxamic Acids/administration & dosage , Indoles/administration & dosage , Waldenstrom Macroglobulinemia/drug therapy , Administration, Oral , Aged , Aged, 80 and over , Biopsy , Disease Progression , Disease-Free Survival , Female , Follow-Up Studies , Histone Deacetylase Inhibitors/adverse effects , Humans , Hydroxamic Acids/adverse effects , Immunoglobulin M/blood , Indoles/adverse effects , Male , Middle Aged , Panobinostat , Recurrence , Treatment Outcome , Waldenstrom Macroglobulinemia/mortality , Waldenstrom Macroglobulinemia/pathology
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