Journal
BRITISH JOURNAL OF HAEMATOLOGY
Volume 176, Issue 4, Pages 583-590Publisher
WILEY
DOI: 10.1111/bjh.14451
Keywords
fenretinide; 4HPR; retinoids; B cell lymphoma; indolent lymphoma
Categories
Funding
- National Institutes of Health [P01CA044991, 5T32CA009515-30, K24CA184039, R21CA119519]
- Cancer Therapy Evaluation Program Translational Research Initiative
- CLL Topics
- Mary Wright Memorial Fund
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Fenretinide, a synthetic retinoid, induces apoptotic cell death in B-cell non-Hodgkin lymphoma (B-NHL) and acts synergistically with rituximab in preclinical models. We report results from a phase I-II study of fenretinide with rituximab for B-NHLs. Eligible diagnoses included indolent B-NHL or mantle cell lymphoma. The phase I design de-escalated from fenretinide at 900mg/m(2) PO BID for days 1-5 of a 7-day cycle. The phase II portion added 375mg/m(2) IV rituximab weekly on weeks 5-9 then every 3months. Fenretinide was continued until progression or intolerance. Thirty-two patients were treated: 7 in phase I, and 25 in phase II of the trial. No dose-limiting toxicities were observed. The phase II component utilized fenretinide 900mg/m(2) twice daily with rituximab. The most common treatment-related adverse events of grade 3 or higher were rash (n=3) and neutropenia (n=3). Responses were seen in 6 (24%) patients on the phase II study, with a median duration of response of 47months (95% confidence interval, 2-56). The combination of fenretinide and rituximab was well tolerated, yielded a modest overall response rate, but with prolonged remission durations. Further study should focus on identifying the responsive subset of B-NHL.
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