Results of a phase I-II study of fenretinide and rituximab for patients with indolent B-cell lymphoma and mantle cell lymphoma
| Autor: | Ted Gooley, Stephen D. Smith, John M. Pagel, George R. Oliveira, Phillip A. Stevenson, Jennifer E. Roden, Brent L. Wood, Andrew J. Cowan, Damian J. Green, Shani L. Frayo, Oliver W. Press, Ajay K. Gopal |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Oncology medicine.medical_specialty Lymphoma B-Cell Neutropenia Fenretinide Phases of clinical research Lymphoma Mantle-Cell Article 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine immune system diseases hemic and lymphatic diseases Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans B-cell lymphoma Aged business.industry Remission Induction Drug Synergism Hematology Exanthema Middle Aged medicine.disease Rash Lymphoma Surgery 030104 developmental biology chemistry 030220 oncology & carcinogenesis Female Rituximab Mantle cell lymphoma medicine.symptom business medicine.drug |
| Zdroj: | British Journal of Haematology. 176:583-590 |
| ISSN: | 0007-1048 |
| DOI: | 10.1111/bjh.14451 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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