Abstract
BackgroundSézary 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 MethodsA 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. ResultsOf 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. ConclusionThe 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.
Highlights
Cutaneous T-cell lymphomas (CTCLs) are rare, initially indolent, non-Hodgkin lymphomas that primarily affect the skin and are often associated with severe pruritus and other morbidities that can profoundly affect the patient’s quality of life (QoL).[1,2,3,4,5] The physical symptoms of CTCL at all stages of disease have been shown to represent a significant burden, on the patients’ physical well-being, and on their psychological and social well-being, such as employment, leisure, and relationships.[6,7,8,9] Compared with earlier, less-advanced stages, advanced-stage disease causes more severe and pervasive negative effects on QoL
These results suggest that patients receiving mogamulizumab had improved QoL associated with their disease- and cancer-specific conditions and overall QoL, with a statistically significant decreased risk of experiencing a more rapid deterioration in their QoL compared with vorinostat
CTCL, the lack of both curative treatments and treatments able to control the cutaneous symptoms of mycosis fungoides (MF) and Sézary syndrome (SS), and the need for prolonged exposure to therapy, any assessment of the clinical benefit of a treatment regimen for patients with MF or SS should include measurements of QoL
Summary
Cutaneous T-cell lymphomas (CTCLs) are rare, initially indolent, non-Hodgkin lymphomas that primarily affect the skin and are often associated with severe pruritus and other morbidities that can profoundly affect the patient’s quality of life (QoL).[1,2,3,4,5] The physical symptoms of CTCL at all stages of disease have been shown to represent a significant burden, on the patients’ physical well-being, and on their psychological and social well-being, such as employment, leisure, and relationships.[6,7,8,9] Compared with earlier, less-advanced stages, advanced-stage disease causes more severe and pervasive negative effects on QoL. The phase III MAVORIC (mogamulizumab vs vorinostat in previously treated cutaneous T-cell lymphoma) trial, to the best of our knowledge the largest prospective trial of systemic therapy for CTCL, compared the efficacy and safety of mogamulizumab, a novel anti-CCR4 monoclonal antibody, for the treatment of adult patients with the 2 most common subtypes of CTCL, mycosis fungoides (MF) and Sézary syndrome (SS), after 1 previous systemic therapy, versus vorinostat (ClinicalTrials.gov identifier, NCT01728805).[10] A total of 372 patients, 186 in each arm, were enrolled. The common treatment-emergent adverse events reported more often with vorinostat included diarrhea (23% vs 62% with mogamulizumab vs vorinostat), nausea (15% vs 42%), thrombocytopenia (11% vs 31%), dysgeusia (3.3% vs 29%), and increased blood creatinine (3.3% vs 28%).[10]
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