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Br J Haematol. 2017 Feb;176(4):583-590. doi: 10.1111/bjh.14451. Epub 2017 Jan 5.

Results of a phase I-II study of fenretinide and rituximab for patients with indolent B-cell lymphoma and mantle cell lymphoma.

Author information

1
Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
2
Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.
3
Department of Radiology, Harvard Medical School, MGH Hospital, Boston, MA, USA.
4
Swedish Cancer Institute, Seattle, WA, USA.
5
Division of Hematopathology, Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.

Abstract

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 900 mg/m2 PO BID for days 1-5 of a 7-day cycle. The phase II portion added 375 mg/m2 IV rituximab weekly on weeks 5-9 then every 3 months. 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 900 mg/m2 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 47 months (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.

KEYWORDS:

4HPR; B cell lymphoma; fenretinide; indolent lymphoma; retinoids

PMID:
28055107
PMCID:
PMC5303179
DOI:
10.1111/bjh.14451
[Indexed for MEDLINE]
Free PMC Article

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