Quality of Life Effect of the Anti-CCR4 Monoclonal Antibody Mogamulizumab Versus Vorinostat in Patients With Cutaneous T-cell Lymphoma

Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):97-105. doi: 10.1016/j.clml.2020.09.003. Epub 2020 Sep 18.

Abstract

Background: Sézary syndrome (SS) and mycosis fungoides (MF), 2 types of cutaneous T-cell lymphoma, cause significant morbidity and adversely affect patients' quality of life (QoL). The present study assessed the QoL measurement changes in patients receiving mogamulizumab versus vorinostat.

Patients and methods: A multicenter phase III trial was conducted of patients with stage IB-IV MF/SS with ≥ 1 failed systemic therapy. The QoL measures included Skindex-29 and the Functional Assessment of Cancer Therapy-General. The symptoms, function, and QoL subdomains were longitudinally modeled using mixed models with prespecified covariates. Meaningful change thresholds (MCTs) were defined using distribution-based methods. The categorical changes by group over time and the time to clinically meaningful worsening were analyzed.

Results: Of the 372 randomized patients, mogamulizumab demonstrated improvement in Skindex-29 symptoms (cycles 3, 5, and 7; P < .05) and functional (cycles 3 and 5; P < .05) scales. A significantly greater proportion of mogamulizumab-treated patients improved by MCTs or more from baseline in the Skindex-29 symptoms domain (cycles 3, 5, 7, and 11) and functioning domain (cycle 5). Significant differences in the Functional Assessment of Cancer Therapy-General physical well-being (cycles 1, 3, and 5; P < .05) were observed in favor of mogamulizumab and a greater proportion of patients had declined by MCTs or more at cycles 1, 3, 5, and 7 with vorinostat treatment. The median time to symptom worsening using Skindex-29 was 27.4 months for mogamulizumab versus 6.6 months for vorinostat. In the patients with SS, the time to worsening favored mogamulizumab (P < .005) for all Skindex-29 domains. The time to worsening was similar for the 2 MF treatment arms.

Conclusion: The symptoms, function, and overall QoL of patients with MF/SS favored mogamulizumab over vorinostat across all time points. Patients with the greatest symptom burden and functional impairment derived the most QoL benefit from mogamulizumab.

Keywords: FACT-G; Mycosis fungoides; Patient-reported outcome; Skindex-29; Sézary syndrome.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Minimal Clinically Important Difference
  • Mycosis Fungoides / complications
  • Mycosis Fungoides / drug therapy*
  • Mycosis Fungoides / psychology
  • Neoplasm Staging
  • Quality of Life*
  • Receptors, CCR4 / antagonists & inhibitors
  • Sezary Syndrome / complications
  • Sezary Syndrome / drug therapy*
  • Sezary Syndrome / psychology
  • Skin Neoplasms / complications
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / psychology
  • Time Factors
  • Treatment Outcome
  • Vorinostat / administration & dosage*

Substances

  • Antibodies, Monoclonal, Humanized
  • CCR4 protein, human
  • Receptors, CCR4
  • Vorinostat
  • mogamulizumab