Health-related quality of life in cutaneous T-cell lymphoma: A post hoc analysis of a phase 3 trial in mycosis fungoides and Sézary syndrome.

in Journal of the European Academy of Dermatology and Venereology : JEADV by P L Ortiz Romero, Y H Kim, K Molloy, P Quaglino, J Scarisbrick, S Thornton, K Sandilands, J E Dent, A Nixon, A Williams, M M Shinohara

TLDR

  • The MAVORIC study looked at how well people with a skin condition called mycosis fungoides (MF) or Sézary syndrome (SS) did with a treatment called mogamulizumab compared to another treatment called vorinostat. The study found that people who got mogamulizumab had better health-related quality of life (HRQL) than those who got vorinostat. The study also found that certain factors, like being female, younger, or having worse symptoms, were associated with worse HRQL. The study highlights the importance of considering individual patients' disease burden when making treatment decisions and suggests that future research should focus on identifying additional factors that may influence HRQL in MF/SS and developing targeted interventions to improve HRQL in this patient population.

Abstract

Mycosis fungoides (MF) and Sézary syndrome (SS) are common subtypes of cutaneous T-cell lymphoma that primarily affect the skin but may spread to the lymph nodes, viscera and blood. The symptom burden may compromise health-related quality of life (HRQL). The phase 3 MAVORIC study (ClinicalTrials.gov identifier NCT01728805) in patients with relapsed/refractory MF/SS reported improved HRQL with mogamulizumab compared with vorinostat. Use baseline (pre-treatment) data from the MAVORIC study to describe the symptom burden of MF/SS and identify characteristics associated with worse HRQL. Data were from 372 adults with stage IB-IVB histologically confirmed relapsed/ refractory MF or SS. Associations between demographic and medical history variables and worse HRQL (Skindex-29, ItchyQol and Functional Assessment of Cancer Therapy - General [FACT-G]) were determined by regression models. In the cohort of 372 adults, 70% were white; 42% were female; mean age was 63 (SD 13.0) years. Fifty-five per cent had MF and 45% had SS; 77% had advanced (stage IIB-IV) disease, involving the skin in all patients and the blood and/or nodes in 66%. HRQL scores showed impairment versus normative means (where available), with the greatest impact on Symptoms and Emotions in the Skindex-29, Functioning in the ItchyQol, and Functional Wellbeing in the FACT-G. In regression analysis, worse HRQL across all domains and total score was associated with being female and younger, worse mSWAT score and worse itch for the Skindex-29 (n = 352), and being female, younger, Black/African American, worse performance status and worse itch for the ItchyQol (n = 369). Associations across domains and total score were not found for the FACT-G. Associations between domains and demographic/medical history were seen for all instruments. The symptoms of advanced MF/SS compromise all HRQL domains. Treatment goals and therapeutic choice should be informed by individual patients' disease burden.

Overview

  • The MAVORIC study aimed to evaluate the impact of mogamulizumab on health-related quality of life (HRQL) in patients with relapsed/refractory mycosis fungoides (MF) or Sézary syndrome (SS).
  • The study used baseline (pre-treatment) data from 372 adults with stage IB-IVB histologically confirmed MF or SS. Associations between demographic and medical history variables and worse HRQL were determined by regression models. HRQL scores showed impairment versus normative means, with the greatest impact on Symptoms and Emotions in the Skindex-29, Functioning in the ItchyQol, and Functional Wellbeing in the FACT-G. Worse HRQL across all domains and total score was associated with being female and younger, worse mSWAT score and worse itch for the Skindex-29, and being female, younger, Black/African American, worse performance status and worse itch for the ItchyQol. Associations between domains and demographic/medical history were seen for all instruments. The symptoms of advanced MF/SS compromise all HRQL domains.

Comparative Analysis & Findings

  • The MAVORIC study compared the outcomes observed under different experimental conditions (mogamulizumab vs vorinostat) in patients with relapsed/refractory MF/SS. The study found improved HRQL with mogamulizumab compared with vorinostat. The key findings of the study were that worse HRQL across all domains and total score was associated with being female and younger, worse mSWAT score and worse itch for the Skindex-29, and being female, younger, Black/African American, worse performance status and worse itch for the ItchyQol. Associations between domains and demographic/medical history were seen for all instruments.

Implications and Future Directions

  • The study's findings highlight the significant impact of advanced MF/SS on HRQL and the importance of considering individual patients' disease burden when making treatment decisions. Future research should focus on identifying additional factors that may influence HRQL in MF/SS and developing targeted interventions to improve HRQL in this patient population. The study's findings also suggest that demographic and medical history variables may be useful predictors of HRQL in MF/SS, which could inform personalized treatment plans and improve patient outcomes.
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