Results from a phase I/II open-label, dose-finding study of pralatrexate and oral bexarotene in patients with relapsed/refractory cutaneous T-cell lymphoma Journal Article


Authors: Duvic, M.; Kim, Y. H.; Zinzani, P. L.; Horwitz, S. M.
Article Title: Results from a phase I/II open-label, dose-finding study of pralatrexate and oral bexarotene in patients with relapsed/refractory cutaneous T-cell lymphoma
Abstract: Purpose: Pralatrexate is a folic acid analogue metabolic inhibitor similar to methotrexate, which has shown tolerability and efficacy with an overall response rate of 45% in a phase I dose deescalation study of patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL). Experimental Design: The object of this phase I/II open-label, multicenter clinical trial was to determine the MTD and recommended dose of pralatrexate plus oral bexarotene in 34 patients with relapsed/refractory CTCL who had failed prior systemic therapies. Pralatrexate was administered by intravenous push at 15 mg/m(2) given weekly 3 weeks out of 4 weeks with daily oral bexarotene (150 or 300 mg/m(2)), levothyroxine, atorvastatin, folate, and with B12 every 2 months. Results: At the MTD of 15mg/m(2) bexarotene and 15mg/m(2) pralatrexate, the response rate was 60% [4 complete responses (CR), 14 partial responses (PR)], the maximum observed response duration was 28.9+ months, and duration of response for 4 CRs ranged from 9.0 to 28.3 months. The median progression-free survival was 12.8 months (0.5-29.9). Mucositis was the most common adverse event. Conclusions: The combination of pralatrexate (15mg/m(2)) and oral bexarotene (150 mg/m(2)) is active with high response rates and minimal toxicity for cutaneous T-cell lymphomas. (C) 2017 AACR.
Keywords: survival; prognostic-factors; task-force; consortium; european-organization; proposal; sezary-syndrome; international-society; mycosis-fungoides; cancer
Journal Title: Clinical Cancer Research
Volume: 23
Issue: 14
ISSN: 1078-0432
Publisher: American Association for Cancer Research  
Date Published: 2017-07-15
Start Page: 3552
End Page: 3556
Language: English
ACCESSION: WOS:000405678400010
DOI: 10.1158/1078-0432.ccr-16-2064
PROVIDER: wos
PMCID: PMC5511551
PUBMED: 28167509
Notes: Article -- Source: Wos
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  1. Steven M Horwitz
    350 Horwitz