Health-Related Quality of Life (HRQL) in Cutaneous T-Cell Lymphoma: A Post Hoc Analysis Examining Disease Burden and Patient Characteristics from the Phase 3 Mavoric Trial in Mycosis Fungoides and Sézary Syndrome

The MAVORIC phase 3 study (NCT01728805) evaluated the efficacy of mogamulizumab compared with vorinostat in patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) - the most common subtypes of cutaneous T-cell lymphoma (CTCL).

This retrospective analysis of baseline (pre-treatment) data from the large well-defined population in the MAVORIC study describes the burden of CTCL on HRQL and identifies characteristics that are associated with poorer HRQL.

The MAVORIC study enrolled patients with stage IB-IVB relapsed or refractory MF/SS that had failed to respond to one or more systemic therapies. HRQL data from the Skindex-29, ItchyQOL, and Functional Assessment of Cancer Therapy - General (FACT-G) were analysed at the item level and scored according to instrument guidelines. Bivariate analysis was used to identify factors associated with relatively poorer HRQL and guided selection of variables for the multivariate analysis.

372 participants were enrolled, 55% with MF and 45% with SS; 77% had advanced (stage IIB-IV) disease. The mean (SD) age was 63 (13.0) years and 42% were female. Disease involved the skin in all participants, blood in 66%, nodes in 66%, viscera in 2%, and other sites in 5%. ECOG performance status was 0, 1, and 2 in 56%, 43%, and 1%, respectively. The domains and total scores for Skindex-29, ItchyQoL and FACT-G are shown in table 1

For individual items, the greatest impairments were seen in skin itch, skin sensitivity, worry of worsening, annoyed by skin condition, sleep, and need to buy special soaps. In bivariate analysis, worse total score across all three HRQL measures was related to being younger, female, having moderate or severe itch, ECOG performance status 1 or 2, and higher Modified Severity-Weighted Assessment Tool (mSWAT) scores. On the Skindex-29 and ItchyQol, worse total scores were also related to Black/African American ethnicity, having disease involving nodes, and higher affected body surface area (BSA). Worse Emotional domain scores across all three HRQL measures was related to being female and having severe itch; worse Functional domain scores were related to disease involving nodes, ECOG performance status 1 or 2, higher mSWAT score, higher affected BSA, and moderate or severe itch. Worse Symptom domain scores (Skindex-29 and ItchyQol) were related to being female, ECOG performance status 1 or 2, higher mSWAT score, higher affected BSA, and severe itch. Differences across HRQL measures will also be reported. In multivariate analysis, worse HRQL was associated with being younger, female, or Black/African American, and with moderate or worse itch and ECOG stage 1 or 2 but was not generally associated with disease stage.

In participants with advanced MF/SS, HRQL was most impacted by symptoms with the impact varying by patient characteristics rather than disease stage. Assessing patients' individual disease concerns may inform treatment goals and therapeutic choice.