PMID- 36751548 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230209 IS - 1642-395X (Print) IS - 2299-0046 (Electronic) IS - 1642-395X (Linking) VI - 38 IP - 2 DP - 2021 Apr TI - 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). PG - 295-301 LID - 10.5114/ada.2021.106206 [doi] AB - 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. CI - Copyright (c) 2022 Termedia. FAU - Chmielowska, Ewa AU - Chmielowska E AD - Bydgoszcz Cancer Centre, Bydgoszcz, Poland. AD - Centre for Diagnostics and Oncology Therapy, Tomaszow Mazowiecki, Poland. AD - Polish Lymphoma Research Group (PLRG). FAU - Sokolowska-Wojdylo, Malgorzata AU - Sokolowska-Wojdylo M AD - Polish Lymphoma Research Group (PLRG). AD - Department of Dermatology, Venerology and Allergology, Faculty of Medicine, Medical University of Gdansk, Gdansk, Poland. FAU - Olszewska, Berenika AU - Olszewska B AD - Department of Dermatology, Venerology and Allergology, Faculty of Medicine, Medical University of Gdansk, Gdansk, Poland. FAU - Studzinski, Maciej AU - Studzinski M AD - Hospital "Elbl(1)ska" Luxmed, Warsaw, Poland. FAU - Grzanka-Gadzinska, Aleksandra AU - Grzanka-Gadzinska A AD - Polish Lymphoma Research Group (PLRG). AD - Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz, Poland. FAU - Zablotna, Monika AU - Zablotna M AD - Department of Dermatology, Venerology and Allergology, Faculty of Medicine, Medical University of Gdansk, Gdansk, Poland. FAU - Olek-Hrab, Karolina AU - Olek-Hrab K AD - Department of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Poznan University of Medical Sciences, Poznan, Poland. FAU - Iwanowski, Tomasz AU - Iwanowski T AD - Dermedica, Gdynia, Poland. FAU - Olejniczak, Monika AU - Olejniczak M AD - Bydgoszcz Cancer Centre, Bydgoszcz, Poland. AD - Centre for Diagnostics and Oncology Therapy, Tomaszow Mazowiecki, Poland. FAU - Krause, Anna AU - Krause A AD - Bydgoszcz Cancer Centre, Bydgoszcz, Poland. AD - Centre for Diagnostics and Oncology Therapy, Tomaszow Mazowiecki, Poland. FAU - Giebel, Sebastian AU - Giebel S AD - Polish Lymphoma Research Group (PLRG). AD - Department of Bone Marrow Transplantation and Oncohaematology, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Gliwice, Poland. LA - eng PT - Journal Article DEP - 20210522 PL - Poland TA - Postepy Dermatol Alergol JT - Postepy dermatologii i alergologii JID - 101168357 PMC - PMC9880780 OTO - NOTNLM OT - cutaneous T-cell lymphoma OT - efficacy OT - interferon OT - methotrexate COIS- The authors declare no conflict of interest. EDAT- 2021/04/01 00:00 MHDA- 2021/04/01 00:01 PMCR- 2021/04/01 CRDT- 2023/02/08 01:58 PHST- 2020/09/07 00:00 [received] PHST- 2020/09/15 00:00 [accepted] PHST- 2023/02/08 01:58 [entrez] PHST- 2021/04/01 00:00 [pubmed] PHST- 2021/04/01 00:01 [medline] PHST- 2021/04/01 00:00 [pmc-release] AID - 44102 [pii] AID - 10.5114/ada.2021.106206 [doi] PST - ppublish SO - Postepy Dermatol Alergol. 2021 Apr;38(2):295-301. doi: 10.5114/ada.2021.106206. Epub 2021 May 22.