Background

Cutaneous T-cell lymphomas (CTCL) are a rare group of non-Hodgkin lymphomas that present in skin. The most studied subtypes, mycosis fungoides (MF) and Sézary syndrome (SS), together represent around two-thirds of all cases. MF/SS disease staging is multi-compartmental utilising a modified TNMB classification. Leukemic involvement in MF/SS has previously been found to be an independent prognostic factor affecting overall survival, disease-specific survival and increasing risk of disease progression (Agar 2010, Am Soc J Clin Oncol), although further research is ongoing.
As a chronic and generally incurable disease associated with disfiguring skin lesions, intractable itching, sleep disturbance, and psychosocial problems, CTCL has a serious negative effect on patient quality of life (QoL). Treatment goals include reducing disease burden, delaying progression, and improving or preserving QoL.
This post hoc analysis of MAVORIC trial data sought to determine whether baseline blood tumour burden affected treatment effect on patient QoL, where patients classified as B0 are considered to have no blood involvement and patients classified as B1 and B2 are considered to have blood involvement.

Methods

The Phase 3 MAVORIC trial (NCT01728805) was an open-label study comparing mogamulizumab (Moga) to vorinostat (Vori). Patient reported outcome (PRO) assessments of health-related QoL (HRQoL) were assessed using the validated Skindex-29, and FACT-G (Functional Assessment of Cancer Therapy - General) instruments. Pruritus was assessed using ItchyQoL and Pruritus Likert Scale. All PROs were administered at baseline and Skindex-29, and FACT-G were then administered at every other treatment visit (Cycle 1, 3, 5,…), and ItchyQoL and Pruritus Likert Scale were administered every 4 weeks at each cycle.

Results

Overall, no statistically significant differences were seen between Moga and Vori for patients with no blood involvement. Statistically significant differences were seen for patients with blood involvement, with Moga patients seeing statistically significant improvement in Skindex-29 for treatment Cycles 3–11 in all domains (Emotional, Functional, Symptoms); and in the Functional Domain of ItchyQoL at most timepoints. In Moga-treated patients with blood involvement, the Pruritus Likert Scale Score showed a reduction in itch from Cycle 1 and a trend to reducing levels of itch over 12 cycles. The FACT-G Total Score showed greatest improvement from baseline for Moga patients with blood involvement compared to those without and all Vori patients (Fig. 1).

Conclusion

Overall, Moga patients with blood involvement saw greater HRQoL improvement than those without blood involvement. Moga offers QoL benefit, assessed across a number of PROs, especially to patients with blood involvement (B1 or B2).