Pierluigi Porcu1, Stacie Hudgens2, Steven Horwitz3, Pietro Quaglino4, Richard Cowan5, Larisa Geskin6, Marie Beylot-Barry7, Lysbeth Floden2, Martine Bagot8, Athanasios Tsianakas9, Alison Moskowitz3, Auris Huen10, Brigitte Dreno11, Stéphane Dalle12, Dolores Caballero13, Mollie Leoni14, Stephen Dale14, Fiona Herr15, Madeleine Duvic10. 1. Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Department of Medical Oncology, Sidney Kimmel Center, Thomas Jefferson University, Philadelphia, PA. Electronic address: pierluigi.porcu@jefferson.edu. 2. Clinical Outcomes Solutions, Tucson, AZ. 3. Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY. 4. Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy. 5. Cancer Research UK - Christie Hospital Foundation NHS Trust, Manchester, UK. 6. Department of Dermatology, New York Presbyterian Hospital, New York, NY. 7. CHU de Bordeaux - Hôpital Saint-André, Bordeaux, France. 8. Service de Dermatologie, Hôpital Saint Louis, Paris, France. 9. Department of Dermatology, Specialist Clinic Bad Bentheim, Bad Bentheim, Germany. 10. Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX. 11. Onco-Dermatology Department, CHU de Nantes - Nantes Hospital, Nantes, France. 12. Immucare, Hospices Civils de Lyon, Cancer Research Center of Lyon, Lyon University, Pierre-Bénite, France. 13. Servicio de Hematología, Hospital Clínico Universitario de Salamanca, Salamanca, Spain. 14. Kyowa Kirin Pharmaceutical Development, Inc, Princeton, NJ. 15. Kyowa Kirin, Inc, Bedminster, NJ.
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.
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.
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