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4.
Leuk Lymphoma ; 62(13): 3109-3118, 2021 12.
Article in English | MEDLINE | ID: mdl-34304674

ABSTRACT

Patients with mycosis fungoides (MF) and Sézary syndrome (SS) often require multiple lines of systemic therapy. In the phase 3 MAVORIC study (NCT01728805), mogamulizumab demonstrated superiority to vorinostat in median progression-free survival (PFS) and confirmed overall response rate (ORR) in patients with MF/SS. This post hoc analysis examined the effects of number and type of prior systemic therapies on mogamulizumab response. MAVORIC patients randomized to mogamulizumab (1.0 mg/kg intravenously weekly) or vorinostat (400 mg orally daily) were grouped by number of prior therapies and immunomodulatory activity of immediate prior systemic therapy while also considering time elapsed since treatment. ORR, PFS, and duration of response (DOR) did not vary with number of prior therapies. ORR and DOR remained consistent regardless of immediate prior therapy type. Additionally, immunomodulatory activity of the last prior therapy and time from prior treatment generally did not affect the ORR or PFS observed in response to mogamulizumab.


Subject(s)
Lymphoma, T-Cell, Cutaneous , Mycosis Fungoides , Sezary Syndrome , Skin Neoplasms , Antibodies, Monoclonal, Humanized/adverse effects , Humans , Lymphoma, T-Cell, Cutaneous/pathology , Mycosis Fungoides/diagnosis , Mycosis Fungoides/drug therapy , Sezary Syndrome/drug therapy , Sezary Syndrome/pathology , Skin Neoplasms/drug therapy , Skin Neoplasms/pathology , Vorinostat
5.
Clin Lymphoma Myeloma Leuk ; 21(2): 97-105, 2021 02.
Article in English | MEDLINE | ID: mdl-33158772

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.


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