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

被引:16
|
作者
Duvic, Madeleine [1 ]
Kim, Youn H. [2 ]
Zinzani, Pier Luigi [3 ]
Horwitz, Steven M. [4 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[2] Stanford Univ, Sch Med, Stanford, CA 94305 USA
[3] Univ Bologna, Inst Hematol Le A Seragnoli, Bologna, Italy
[4] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
关键词
MYCOSIS-FUNGOIDES; SEZARY-SYNDROME; INTERNATIONAL-SOCIETY; EUROPEAN-ORGANIZATION; PROGNOSTIC-FACTORS; TASK-FORCE; CONSORTIUM; SURVIVAL; OUTCOMES;
D O I
10.1158/1078-0432.CCR-16-2064
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:3552 / 3556
页数:5
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