Efficacy, quality of life, and safety of methotrexate versus interferon in head-to-head treatment in advanced stages of mycosis fungoides and Sezary syndrome. Prospective trial (NCT02323659)

Introduction
ESMO guidelines recommend interferon (IFN) and methotrexate (MTX) as first-line systemic therapies in mycosis fungoides (MF) and Sezary syndrome (SS).

Aim
A prospective, head-to-head trial comparing the efficacy and safety of INF-a and MTX as first-line treatment in MF/SS patients.

Material and methods
Forty-three patients were enrolled in the trial. The response to treatment and side effects were assessed. Study variables included mSWAT, DLQI, and VAS scores.

Results
The response rate in stage IV including SS was significantly higher in the IFN-a group than in the MTX group (100% vs. 40%; p = 0.03, respectively). No significant differences were found in response rate in stage IIB and III between treatment groups. Patients treated with IFN-a had significantly shorter time to achieve response (TTR). Significantly fewer in the IFN-a group experienced adverse events (AE) in comparison to patients treated with MTX (81% vs. 45%; p = 0.02). There was no statistically significant difference between both groups in terms of time to progression (TTP), progression-free survival (PFS), time on treatment (ToT), and time to next treatment (TTNT). The improvement in quality of life and reduction of pruritus was comparable in both treatment groups.

Conclusions
The obtained data suggest that the efficacy of IFN-a as first-line treatment in advanced stage (IV) MF and SS is significantly better than MTX. IFN-a presented significantly better safety and tolerability and shorter TTR than MTX. However, the results should be interpreted with caution due to scarce study groups.