Journal of the European Academy of Dermatology and Venereology : JEADV · 2024
Effectiveness and safety of methotrexate in the treatment of mycosis fungoides: Real-world data from a multicentre study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Nikolaou Vasiliki, Panou Evdoxia, Tsimpidakis Antonios, Koumprentziotis Ioannis-Alexios, Patsatsi Aikaterini, Siakantaris Marina, Kruger-Krasagakis Sabine-Elke, Marinos Leonidas, Georgiou Elisavet, Lampadaki Kyriaki, Velissari Aliki, Daponte Athina-Ioanna, Doxastaki Aikaterini, Kaliampou Stella, Vaiopoulos Aristeidis, Konstandinou Iliana, Koumourtzis Marios, Lakiotaki Eleftheria, Pappa Vassiliki, Tsamaldoupis Athanasios, Stratigos Alexander, Papadavid Evangelia
Аннотация
BACKGROUND: Methotrexate (MTX) has been a longstanding therapeutic option for mycosis fungoides (MF); however, data on its real-world effectiveness remain limited.
OBJECTIVES: To evaluate treatment-related outcomes of oral MTX in patients with early- and late-stage MF.
METHODS: This is a retrospective multicentre analysis involving MF subjects from five referral centres for cutaneous lymphomas in Greece. Data regarding the effectiveness and safety were analysed.
RESULTS: In total, 211 MF patients were enrolled (males, 68.3%) with a median (IQR) age of diagnosis at 68.3 (56-75) years. Late-stage (IIB-IVB) disease was present in 124 patients (59.3%). MTX monotherapy was administered to 112 (53.1%) patients, with 99 receiving combination regimens with phototherapy, interferon and retinoids. MTX was used as first-line regimen in 103 (48.9%) cases. An overall response rate (ORR) of 55.5% was observed with 29.9% of patients achieving complete responses. MTX demonstrated greater effectiveness as a first-line treatment compared to subsequent use with no significant differences between monotherapy and combination therapy. The median time to best response was 3.8 months (IQR 2.3-9.9 months). Patients with erythrodermic disease (Stage III) had better ORRs compared to patients with tumour stage disease (Stage II) (61.1% vs. 44.8% respectively). The progression-free survival (PFS) varied according to stage, with a median PFS of 17.1 months for early-stage disease, 5.7 months for Stage IIB disease, 46 months for Stage III and 9.6 months for Stage IV disease (0.7-.). Serious adverse (Grade 3) events leading to treatment discontinuation occurred in 14 (6.7%) cases. All patients received oral MTX once weekly with a median weekly dose of 15 mg/week (7.5-25).
CONCLUSIONS: Our findings support MTX as a viable treatment option for MF, particularly when used in the first-line setting, offering a favourable benefit/risk profile. Response rates are stage-dependent, with erythrodermic patients achieving superior and durable responses.
OBJECTIVES: To evaluate treatment-related outcomes of oral MTX in patients with early- and late-stage MF.
METHODS: This is a retrospective multicentre analysis involving MF subjects from five referral centres for cutaneous lymphomas in Greece. Data regarding the effectiveness and safety were analysed.
RESULTS: In total, 211 MF patients were enrolled (males, 68.3%) with a median (IQR) age of diagnosis at 68.3 (56-75) years. Late-stage (IIB-IVB) disease was present in 124 patients (59.3%). MTX monotherapy was administered to 112 (53.1%) patients, with 99 receiving combination regimens with phototherapy, interferon and retinoids. MTX was used as first-line regimen in 103 (48.9%) cases. An overall response rate (ORR) of 55.5% was observed with 29.9% of patients achieving complete responses. MTX demonstrated greater effectiveness as a first-line treatment compared to subsequent use with no significant differences between monotherapy and combination therapy. The median time to best response was 3.8 months (IQR 2.3-9.9 months). Patients with erythrodermic disease (Stage III) had better ORRs compared to patients with tumour stage disease (Stage II) (61.1% vs. 44.8% respectively). The progression-free survival (PFS) varied according to stage, with a median PFS of 17.1 months for early-stage disease, 5.7 months for Stage IIB disease, 46 months for Stage III and 9.6 months for Stage IV disease (0.7-.). Serious adverse (Grade 3) events leading to treatment discontinuation occurred in 14 (6.7%) cases. All patients received oral MTX once weekly with a median weekly dose of 15 mg/week (7.5-25).
CONCLUSIONS: Our findings support MTX as a viable treatment option for MF, particularly when used in the first-line setting, offering a favourable benefit/risk profile. Response rates are stage-dependent, with erythrodermic patients achieving superior and durable responses.