Pralatrexate alone or in combination with bexarotene: long-term tolerability in relapsed/refractory mycosis fungoides.

Abstract

BACKGROUND:

This study aimed to assess the long-term tolerability of pralatrexate alone or in combination with oral bexarotene for relapsed or refractory mycosis fungoides (MF).

PATIENTS AND METHODS:

Patients with MF in this report were participants in 1 of 2 multicenter trials. During the dose-ranging phase I/II study, participants were treated with pralatrexate alone for 3 of 4 weeks. During a second phase I/II dose-ranging combination trial, participants were treated with pralatrexate at 15 mg/m(2)/wk for 3 of 4 weeks combined with 150 to 300 mg/m(2) of daily oral bexarotene.

RESULTS:

Twenty-six patients were enrolled at our center, including 12 receiving pralatrexate and 14 receiving pralatrexate plus bexarotene. Four of 12 patients (33%) treated with pralatrexate alone responded. Of 14 patients treated with bexarotene plus pralatrexate, 7 (50%) responded. Ten participants, with a median age of 71 years (range, 41-82 years), received more than 9 cycles of pralatrexate, including 3 receiving pralatrexate and 7 receiving combination therapy. Median time to response was 15.75 weeks (range, 4-24 weeks), and the median duration of response was 26.75 weeks (range, 8.5-49.5 weeks). The most common adverse event (AE) was mucositis in 8 (80%) patients. Other AEs of any grade included arthralgias (n = 1), headache (n = 1), neutropenia (n = 5), and skin necrosis (n = 2). Two patients initially had lower leg tumors that responded to therapy, leaving residual chronic leg ulcers.

CONCLUSION:

Pralatrexate alone or in combination with low-dose oral bexarotene is well tolerated and capable of providing long-term responses in patients of advanced age with advanced-stage MF.

• Authors: Rakhshandra Talpur, Andrew Thompson, Pamela Gangar, Madeleine Duvic
• Journal: Clinical lymphoma, myeloma & leukemia (Clin Lymphoma Myeloma Leuk) Vol. 14 Issue 4 Pg. 297-304 (Aug 2014) ISSN: 2152-2669 [Electronic] United States
• PMID: 24589156 (Publication Type: Journal Article)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• 10-propargyl-10-deazaaminopterin
• Tetrahydronaphthalenes
• Bexarotene
• Aminopterin

Topics

• Adult
• Aged
• Aged, 80 and over
• Aminopterin (administration & dosage, analogs & derivatives, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bexarotene
• Female
• Humans
• Male
• Middle Aged
• Mycosis Fungoides (drug therapy, pathology)
• Neoplasm Recurrence, Local
• Retrospective Studies
• Tetrahydronaphthalenes (administration & dosage, therapeutic use)
• Treatment Outcome