Evaluation of Symptom and Side Effect Bother in Cutaneous T-cell Lymphoma Patients Treated with Mogamulizumab or Vorinostat

Abstract Background: Cutaneous T-cell lymphomas, including mycosis fungoides or Sézary syndrome, are rare non-Hodgkin lymphomas that can be serious and life-threatening with significant morbidity and impaired quality of life. The purpose of this study was to determine whether patient-reported outcome individual items on skin symptoms and toxicity bother show significant treatment differences for patients with mycosis fungoides or Sézary syndrome.Methods: Health-related quality of life was assessed during the MAVORIC clinical trial of mogamulizumab for treatment of cutaneous T-cell lymphomas compared to vorinostat using the Skindex-29 (measures emotions, symptoms, and functioning) and Functional Assessment of Cancer Therapy – General (FACT-G) (assesses physical, social/family, emotional, and functional well-being). Pruritus was assessed with the ItchyQoL (measures symptoms, functioning, and emotions) and Likert Scale for level of itching. Item analyses used longitudinal generalized estimation equations of the post-baseline, treated period assessments to estimate likelihood of improvement. Forest plots of odds ratios (OR) characterized the likelihood of a 1- and 2-grade categorical improvement on individual items.Results: Patients treated with mogamulizumab were more likely to observe a 1-grade improvement in painful skin (OR = 1.74, CI: 1.180–2.572), irritated skin (OR = 1.34, CI: 0.909–1.978), lack of energy (OR = 2.20, CI: 1.461–3.309), side effect bother (OR = 1.28, CI: 0.810–2.020), and general cancer pain (OR = 1.38, CI: 0.922–2.063). Patients treated with mogamulizumab were more likely to observe a 2-grade improvement in burning or stinging skin (OR = 1.62, CI: 1.013–2.591, P < 0.05) and more likely to observe improvement in painful skin (OR = 1.78, CI: 1.045–3.021, P < 0.05).Conclusions: Single item analyses suggest a mogamulizumab symptom benefit during treatment compared to vorinostat for items on the skin symptoms of Skindex-29 and toxicity bother items of FACT-G.Trial registration: NCT01728805