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-alpha 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-alpha 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-alpha had significantly shorter time to achieve response (TTR). Significantly fewer in the IFN-alpha 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-alpha as first-line treatment in advanced stage (IV) MF and SS is significantly better than MTX. IFN-alpha presented significantly better safety and tolerability and shorter TTR than MTX. However, the results should be interpreted with caution due to scarce study groups.