Quality of life effect of the anti-CCR4 monoclonal antibody mogamulizumab versus vorinostat in patients with cutaneous T-cell lymphoma Journal Article

Authors: Porcu, P.; Hudgens, S.; Horwitz, S.; Quaglino, P.; Cowan, R.; Geskin, L.; Beylot-Barry, M.; Floden, L.; Bagot, M.; Tsianakas, A.; Moskowitz, A.; Huen, A.; Dreno, B.; Dalle, S.; Caballero, D.; Leoni, M.; Dale, S.; Herr, F.; Duvic, M.
Article Title: Quality of life effect of the anti-CCR4 monoclonal antibody mogamulizumab versus vorinostat in patients with cutaneous T-cell lymphoma
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. Cutaneous T-cell lymphoma, including mycosis fungoides and Sézary syndrome, cause itching and other symptoms that can impair patients’ quality of life (QoL). The present prespecified analysis examined in detail how monoclonal antibody mogamulizumab treatment improved patients’ symptoms, function, and overall QoL across time points relative to vorinostat, providing a health-related QoL benchmark for these patients. © 2020 The Authors
Keywords: mycosis fungoides; patient-reported outcome; fact-g; skindex-29; sézary syndrome
Journal Title: Clinical Lymphoma, Myeloma and Leukemia
Volume: 21
Issue: 2
ISSN: 2152-2650
Publisher: Elsevier Inc.  
Date Published: 2021-02-01
Start Page: 97
End Page: 105
Language: English
DOI: 10.1016/j.clml.2020.09.003
PUBMED: 33158772
PROVIDER: scopus
PMCID: PMC7878351
Notes: Article -- Export Date: 1 April 2021 -- Source: Scopus
Citation Impact
MSK Authors
  1. Steven M Horwitz
    565 Horwitz
  2. Alison Moskowitz
    276 Moskowitz