Pralatrexate is an effective treatment for relapsed or refractory transformed mycosis fungoides: a subgroup efficacy analysis from the PROPEL study. Academic Article Article uri icon

Overview

MeSH

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Disease-Free Survival
  • Folic Acid Antagonists
  • Humans
  • Middle Aged
  • Prognosis
  • Recurrence
  • Retrospective Studies
  • Survival Analysis

MeSH Major

  • Aminopterin
  • Mycosis Fungoides

abstract

  • Transformed mycosis fungoides (tMF) is an aggressive disease with a median survival of 12-24 months. In this retrospective analysis of 12 patients with tMF, treatment with pralatrexate resulted in an objective response of 25% per independent central review and 58% per investigator assessment. Pralatrexate was well tolerated, with no toxicity-related discontinuations, which makes this an additional option for tMF treatment. Transformed mycosis fungoides (tMF) is an aggressive disease, with poor prognosis and a median survival of 24 months. In the Pralatrexate in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PROPEL) study, 12 patients with tMF were treated with a median of 10 pralatrexate doses (starting dose of 30 mg/m(2)) administered weekly for 6 weeks in a 7-week cycle. The median number of prior systemic therapies was 3. This retrospective analysis showed that the objective response rate in this subgroup was 25% (n = 3) per independent central review and 58% (n = 7) per investigator assessment, with this discrepancy likely attributed to challenges with photodocumentation of cutaneous lesions. The median duration of response and the median progression-free survival were 2.2 and 1.7 months, respectively, per central review, whereas median duration of response was 4.4 months, and median progression-free survival was 5.3 months per investigator assessment. Median survival was 13 months. Grade 1-3 mucositis was reported in 7 (58%) patients. Grade 4 adverse events were fatigue (n = 1) and thrombocytopenia (n = 1). Pralatrexate was well tolerated, with no toxicity-related discontinuations. Based on these results, pralatrexate may be a treatment option for patients with relapsed or refractory tMF. Copyright © 2012. Published by Elsevier Inc.

publication date

  • August 2012

has subject area

  • Adult
  • Aged
  • Aged, 80 and over
  • Aminopterin
  • Antineoplastic Combined Chemotherapy Protocols
  • Disease-Free Survival
  • Folic Acid Antagonists
  • Humans
  • Middle Aged
  • Mycosis Fungoides
  • Prognosis
  • Recurrence
  • Retrospective Studies
  • Survival Analysis

Research

keywords

  • Clinical Trial, Phase II
  • Journal Article
  • Multicenter Study

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1016/j.clml.2012.01.010

PubMed ID

  • 22542448

Additional Document Info

start page

  • 238

end page

  • 243

volume

  • 12

number

  • 4