Chlormethine gel is effective for the treatment of skin lesions in patients with early‐ and late‐stage mycosis fungoides in clinical practice

Abstract

Background Chlormethine gel is a skin-directed therapy used for patients with mycosis fungoides (MF) that showed a favourable risk/benefit profile in a randomized clinical trial. Currently, data on chlormethine gel use in real-world settings are limited.Objectives The aim of this study was to assess safety and efficacy of chlormethine gel treatment in patients treated during daily clinical practice and investigate associations between response and disease stage, lesion type, mono-or combination therapy, and occurrence of dermatitis.Methods Clinical data from patients using chlormethine gel from three sites in Greece were analysed. Efficacy was assessed through modified Severity-Weighted Assessment Tool (mSWAT) scores. Safety assessments included analysis of the occurrence and severity of dermatitis. The Skindex-29 questionnaire was used for quality-of-life assessments.Results Fifty-eight patients were included. The overall response rate (ORR) increased from 37.9% at month 1 to 80.8% at month 9. For 64.2% of patients, response was maintained for at least 4 months (ORR4). At month 3, a higher ORR was seen for patients with patches (69.7%) than patients with plaques/tumours (both 15.2%). A higher ORR4 was observed for patients with early-vs late-stage disease (71.4% vs. 36.4%) and patients on mono-vs combination therapy (75% vs. 47.6%). Dermatitis was observed in the majority of patients (72.4%), but the presence or severity of dermatitis was not directly correlated with treatment response. Both mSWAT and Skindex-29 scores decreased significantly during treatment, and changes in these scores from baseline to month 6 showed a positive correlation (r = 0.55, P = 0.026).Conclusions Chlormethine gel was effective for the treatment of skin lesions in patients with early-and late-stage MF in clinical practice. Response rates increased over time, indicating that continued treatment with the gel is important.Dermatitis may be managed by reducing the treatment frequency; the occurrence of dermatitis did not affect the response to treatment.

Prior Bexarotene or Phototherapy Does Not Affect Response to Chlormethine Gel: Post Hoc Analysis of a Pivotal Trial

“…In a retrospective evaluation of 18 patients, only 1 was treatment-naïve when initiating chlormethine gel, with 7 patients having received 2–4 prior lines of therapy and 8 patients having had more than 5 prior therapies ( 7 ). Another retrospective study included 58 patients who all received prior therapies, including prior phototherapy or bexarotene, and had good responses to chlormethine gel treatment ( 8 ).…”

Mechlorethamine Hydrochloride Gel in the Treatment of Mycosis Fungoides–Type Cutaneous T-Cell Lymphoma (MF-CTCL): A Focus on Patient Selection and Special Considerations

“… Development of contact dermatitis associated with CAILs response (p = 0.0001). Papadavid et al (2022) 15 Retrospective analysis N = 58 Stage IA–IIB NM 0.02% gel monotherapy or combination therapy ORR assessed as ≥ 50% improvement in mSWAT scores. Quality-of-life assessments via Skindex-29.…”

“…9 In a 2022 study of 58 patients based out of Greece, gel-based NM was also found to be safe and effective in a real-world setting; however, 72.4% experienced some form of skin irritation. 15 …”

“…A series of 58 patients from Greece found an overall response rate of 36.4% for patients with late-stage MF after 4 months of NM gel (vs. 71.4% for patients with early-stage MF), suggesting that patients with advanced MF likely have lower response rates to NM gel compared to those with early disease. 15 In clinical practice at expert treatment centers, NM gel is used as an adjunctive rather than primary treatment in advanced stage disease. 20 …”

“…9 In a 2022 study of 58 patients based out of Greece, gel-based NM was also found to be safe and effective in a real-world setting; however, 72.4% experienced some form of skin irritation. 15 Development of contact dermatitis may lead to better response from NM preparations, including NM gel. The Stanford group observed that patients who have a brisk local contact dermatitis to NM preparations could have earlier and more complete clearance of MF lesions.…”