Journal
LEUKEMIA & LYMPHOMA
Volume 54, Issue 7, Pages 1373-1379Publisher
INFORMA HEALTHCARE
DOI: 10.3109/10428194.2012.742521
Keywords
Denileukin diftitox; CHOP; lymphoma; T-cell; phase II; clinical trial; fusion protein toxin
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Funding
- Eisai Inc.
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This phase II study to determine the safety and efficacy of denileukin diftitox (DD) and cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) enrolled patients with newly diagnosed peripheral T-cell lymphoma (PTCL). Forty-nine received DD 18 mu g/kg/day (days 1, 2) with CHOP (day 3) every 21 days for <= 6-8 cycles. Intent-to-treat (ITT) and safety populations comprised all patients. In the ITT population, the overall response rate was 65%, median duration of response was 30 months and median progression-free survival was 12 months. Median overall survival was not attained at the end of the study, and the overall survival rate was 63.3%. The two most frequent treatment-related adverse events (AEs) were fatigue and nausea. Most frequent AEs >= grade 3 within the hematologic system were lymphopenia (24.5%), neutropenia (20.4%) and leukopenia (18.4%). Three treatment-related deaths occurred. DD plus CHOP was well tolerated, and progression-free and overall survival improved versus historical comparison with CHOP alone. Confirmation in larger trials is warranted.
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