{"doi":"10.1016/j.clml.2020.09.003","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.","journal":"Clinical Lymphoma Myeloma & Leukemia","year":2020,"id":96700,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":34,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9598,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":479068,"name":"Stacie Hudgens","orcid":"0000-0002-7350-1549","position":1,"is_corresponding":false},{"id":479069,"name":"Sarah McCue Horwitz","orcid":"0000-0002-5262-1170","position":2,"is_corresponding":false},{"id":291856,"name":"Pietro Quaglino","orcid":"0000-0003-4185-9586","position":3,"is_corresponding":false},{"id":291857,"name":"Richard Cowan","orcid":"0000-0001-9004-8136","position":4,"is_corresponding":false},{"id":409106,"name":"Larisa J. Geskin","orcid":"0000-0002-0981-3513","position":5,"is_corresponding":false},{"id":479070,"name":"M. Beylot‐Barry","orcid":"0000-0001-6150-1229","position":6,"is_corresponding":false},{"id":479071,"name":"Lysbeth Floden","orcid":"0000-0003-0584-6227","position":7,"is_corresponding":false},{"id":291860,"name":"M. Bagot","orcid":"0000-0002-1631-5192","position":8,"is_corresponding":false},{"id":479072,"name":"Athanasios Tsianakas","orcid":"0000-0002-3430-4251","position":9,"is_corresponding":false},{"id":246211,"name":"Alison J. Moskowitz","orcid":"0000-0002-3408-050X","position":10,"is_corresponding":false},{"id":479073,"name":"Auris Huen","orcid":"0000-0002-6403-7449","position":11,"is_corresponding":false},{"id":68946,"name":"Brigitte Dréno","orcid":"0000-0001-5574-5825","position":12,"is_corresponding":false},{"id":479074,"name":"Stéphane Dalle","orcid":"0000-0002-3423-4548","position":13,"is_corresponding":false},{"id":480064,"name":"Dolores Caballero","orcid":null,"position":14,"is_corresponding":false},{"id":479075,"name":"Mollie Leoni","orcid":"0000-0001-6585-7919","position":15,"is_corresponding":false},{"id":479076,"name":"Stephen Dale","orcid":"0009-0002-1113-7136","position":16,"is_corresponding":false},{"id":480065,"name":"Fiona Herr","orcid":null,"position":17,"is_corresponding":false},{"id":459045,"name":"Madeleine Duvic","orcid":"0000-0002-8971-4565","position":18,"is_corresponding":false},{"id":479067,"name":"Pierluigi Porcu","orcid":"0000-0002-8056-023X","position":0,"is_corresponding":true}],"reference_count":24,"raw_metadata":null,"created_at":"2026-07-18T22:35:06.014648Z","pmid":"33158772","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}