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)

Ewa Chmielowska; Małgorzata Sokołowska-Wojdyło; Berenika Olszewska; Maciej Studziński; Aleksandra Grzanka-Gadzińska; Monika Zabłotna; Karolina Olek-Hrab; Tomasz Iwanowski; Monika Olejniczak; Anna Krause; Sebastian Giebel

doi:10.5114/ada.2021.106206

eISSN: 2299-0046
ISSN: 1642-395X

Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii

Current issue Archive Manuscripts accepted About the journal Editorial board Reviewers Abstracting and indexing Subscription Contact Instructions for authors Publication charge Ethical standards and procedures

Editorial System

Submit your Manuscript

Editorial Policies

Sarajevo Declaration on Integrity and Visibility of Scholarly Publications

2/2021
vol. 38

Send email

Copy url:

abstract:

Original paper

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)

Ewa Chmielowska

^{1, 2, 3}

,

Małgorzata Sokołowska-Wojdyło

^{3, 4}

,

Berenika Olszewska

⁴

,

Maciej Studziński

⁵

,

Aleksandra Grzanka-Gadzińska

^{3, 6}

,

Monika Zabłotna

⁴

,

Karolina Olek-Hrab

⁷

,

Tomasz Iwanowski

⁸

,

Monika Olejniczak

^{1, 2}

,

Anna Krause

^{1, 2}

,

Sebastian Giebel

^{3, 9}

Bydgoszcz Cancer Centre, Bydgoszcz, Poland
Centre for Diagnostics and Oncology Therapy, Tomaszow Mazowiecki, Poland
Polish Lymphoma Research Group (PLRG)
Department of Dermatology, Venerology and Allergology, Faculty of Medicine, Medical University of Gdansk, Gdansk, Poland
Hospital “Elbląska” Luxmed, Warsaw, Poland
Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz, Poland
Department of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Poznan University of Medical Sciences, Poznan, Poland
Dermedica, Gdynia, Poland
Department of Bone Marrow Transplantation and Oncohaematology, Maria Sk³odowska-Curie Memorial Cancer Centre and Institute of Oncology, Gliwice, Poland

Adv Dermatol Allergol 2021; XXXVIII (2): 295-301

DOI: https://doi.org/10.5114/ada.2021.106206

Online publish date: 2021/05/22

View full text Get citation

EndNote

Papers, Reference Manager, RefWorks, Zotero

AMA

Chmielowska E, Sokołowska-Wojdyło M, Olszewska B, et al. 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). Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2021;38(2):295-301. doi:10.5114/ada.2021.106206.

APA

Chmielowska, E., Sokołowska-Wojdyło, M., Olszewska, B., Studziński, M., Grzanka-Gadzińska, A.,  & Zabłotna, M. et al. (2021). 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). Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 38(2), 295-301. https://doi.org/10.5114/ada.2021.106206

Chicago

Chmielowska, Ewa, Małgorzata Sokołowska-Wojdyło, Berenika Olszewska, Maciej Studziński, Aleksandra Grzanka-Gadzińska, Monika Zabłotna,  and Karolina Olek-Hrab et al. 2021. "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)". Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii 38 (2): 295-301. doi:10.5114/ada.2021.106206.

Harvard

Chmielowska, E., Sokołowska-Wojdyło, M., Olszewska, B., Studziński, M., Grzanka-Gadzińska, A., Zabłotna, M., Olek-Hrab, K., Iwanowski, T., Olejniczak, M., Krause, A.,  and Giebel, S. (2021). 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). Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 38(2), pp.295-301. https://doi.org/10.5114/ada.2021.106206

MLA

Chmielowska, Ewa et al. "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)." Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, vol. 38, no. 2, 2021, pp. 295-301. doi:10.5114/ada.2021.106206.

Vancouver

Chmielowska E, Sokołowska-Wojdyło M, Olszewska B, Studziński M, Grzanka-Gadzińska A, Zabłotna M et al. 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). Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2021;38(2):295-301. doi:10.5114/ada.2021.106206.

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.

keywords:

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)

Ewa Chmielowska 1, 2, 3 , Małgorzata Sokołowska-Wojdyło 3, 4 , Berenika Olszewska 4 , Maciej Studziński 5 , Aleksandra Grzanka-Gadzińska 3, 6 , Monika Zabłotna 4 , Karolina Olek-Hrab 7 , Tomasz Iwanowski 8 , Monika Olejniczak 1, 2 , Anna Krause 1, 2 , Sebastian Giebel 3, 9

methotrexate, interferon, cutaneous T-cell lymphoma, efficacy