title: 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).
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Rakhshandra
authors.initials: R
authors.lastname: Talpur
authors.affiliation: Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Andrew
authors.initials: A
authors.lastname: Thompson
authors.affiliation: Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Pamela
authors.initials: P
authors.lastname: Gangar
authors.affiliation: Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: mduvic@mdanderson.org.
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000630:Aminopterin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D000077610:Bexarotene; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy* / Q000473:pathology; D009364:Neoplasm Recurrence, Local; D012189:Retrospective Studies; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: C418863:10-propargyl-10-deazaaminopterin; D013764:Tetrahydronaphthalenes; D000077610:Bexarotene; D000630:Aminopterin
keywords: Extracorporeal photopheresis; Folic acid inhibitor; Mycosis fungoides; Nitrogen mustard; Sézary syndrome; T cell