Multicenter photopheresis intervention trial in early-stage mycosis fungoides

Clin Lymphoma Myeloma Leuk. 2011 Apr;11(2):219-27. doi: 10.1016/j.clml.2011.03.003. Epub 2011 Apr 8.

Abstract

Purpose: To demonstrate the efficacy of the UVAR XTS Photopheresis System and evaluate health-related quality of life in patients with early-stage mycosis fungoides (MF).

Patients and methods: Extracorporeal photopheresis was administered 2 days every 4 weeks for 6 months. Patients with partial responses by skin weighted assessment continued for 6 months; nonresponders added oral bexarotene and/or interferon α. Health-related quality of life was assessed at baseline and every 3 months with 3 validated tools.

Results: Nineteen patients with early-stage MF (7 men, 12 women; 16 white, 3 African Americans) with median age of 63.5 years (range, 46-85 years) participated. Their stages were IA (n = 3), IB (n = 14), and IIA (n = 2). The overall response rate for extracorporeal photopheresis (ECP) alone, was 42% (8/19; including 7 partial response, 1 complete response), with a median of 12 ECP sessions (range, 3-32) given over a median of 12 months (3-32 months) and with an overall duration of response of 6.5 months (range, 1-48 months). Seven patients with stable disease at 3 months received additional bexarotene (3/5; 1 complete response) or bexarotene plus interferon α (1/2), and 4 (57%) of 7 responded. Treatment-related adverse effects were limited to those expected with interferon (fatigue, nausea, vomiting, and diarrhea), or with hypertriglyceridemia and bexarotene. Trends in health-related quality of life indicated an improvement in emotional scores over time.

Conclusions: ECP is effective for patients with early-stage MF alone or in combination with biologic response modifiers with low toxicity and improved quality of life.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use
  • Bexarotene
  • CD4 Lymphocyte Count
  • Female
  • Humans
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use
  • Male
  • Middle Aged
  • Mycosis Fungoides / immunology
  • Mycosis Fungoides / pathology
  • Mycosis Fungoides / therapy*
  • Neoplasm Staging
  • Photopheresis*
  • Quality of Life
  • T-Lymphocytes / immunology
  • Tetrahydronaphthalenes / adverse effects
  • Tetrahydronaphthalenes / therapeutic use
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Interferon-alpha
  • Tetrahydronaphthalenes
  • Bexarotene