Interviews with patients and their spouses to capture personal descriptions of early treatment experience with mogamulizumab for mycosis fungoides (MF) and Sezary syndrome (SS)

Abstract

Background: Mycosis fungoides (MF) and Sézary syndrome (SS) are rare and chronic non-Hodgkin lymphomas that present in skin and can progress to involve extracutaneous sites. For many patients, skin lesions are disfiguring with an intractable itch. Other symptoms can include difficulty regulating body temperature and sleep disturbance. Symptomatic MF and SS can have a negative impact on health-related quality of life (HRQL). Mogamulizumab is approved in Europe for the treatment of adult patients with MF or SS after at least one prior systemic therapy based on the efficacy and safety demonstrated in the phase 3 MAVORIC trial (NCT01728805). Objectives: To capture personal descriptions from patients and their spouses of the burden of MF and SS before starting mogamulizumab treatment and their early treatment experience. Methods: Five patients and three spouses were recruited at two hospital clinics in the UK. Following informed consent, 1:1 semi-structured, 60-minute telephone interviews were conducted. Participants were asked about their experience of symptoms and impact of their condition on domains of HRQL prior to starting treatment with mogamulizumab, and any changes during the first six months of treatment. Spouses were also asked about any impact on their role as a carer since mogamulizumab treatment was initiated. Interviews were transcribed, responses coded, and narrative summary provided. Findings: Prior to treatment with mogamulizumab, patients and their spouses reported moderate-to-severe problems with all skin-related symptoms and regulating their body temperature. The majority described fatigue and sleep problems, with spouses also reporting patients’ moderate-to-severe problems with those symptoms. On starting mogamulizumab, both patients and their spouses described rapid improvement in itching, with gradual improvement in skin flaking, redness, and pain/discomfort. Similarly, body temperature regulation, fatigue and sleep quality gradually improved in the first six months of treatment. There was a wide distribution in the reported level of disease impact on HRQL domains prior to treatment with mogamulizumab including emotional well-being, ability to self-care, activities of daily living, social well-being, and family relationships. Symptom presentation on hands and feet was associated with greater impact on these QoL domains. For those with moderate-to-severe problems pre-treatment, patients and spouses described a meaningful reduction in the level of impairment, sometimes within the first few months of treatment. Spouses reported that their everyday life as a carer had positively changed since their partner had received treatment with mogamulizumab. Conclusion: Participants described multiple symptoms and the detrimental impact on their HRQL prior to treatment with mogamulizumab. There was a rapid improvement in itching with improvement in other symptoms and overall HRQL in the first six months of mogamulizumab treatment.