Chlormethine gel shows safety, efficacy in mycosis fungoides cutaneous T-cell lymphoma

Chlormethine gel showed efficacy in combination with corticosteroids or other treatments such as phototherapy in a cohort of patients with mycosis fungoides cutaneous T-cell lymphoma, according to the PROVe study.

Ellen J. Kim, MD, of the department of dermatology at the Perelman School of Medicine, University of Pennsylvania, and colleagues described chlormethine/mechlorethamine gel as a skin-directed therapy that may have utility in this patient population. “Currently, real-world data on chlormethine gel are lacking,” they wrote.

The aim of the prospective, observational study was to assess the efficacy, safety and health-related quality of life (QOL) of chlormethine gel in various combinations in a cohort of 298 patients in a real-world setting. The researchers reported that 0.016% w/w chlormethine gel was administered with corticosteroids or with other interventions such as phototherapy or oral bexarotene.

While study protocols called for a monitoring period of up to 2 years, there was no specific schedule of clinical assessments, except patient-completed questionnaires, due to “expected variability in practice patterns,” according to the researchers.

The proportion of patients with stage IA-IB cutaneous T-cell lymphoma treated with chlormethine plus topical corticosteroids plus other treatments who experienced a 50% or greater decrease in body surface area between baseline and 12 months served as the primary efficacy outcome. The study also included safety endpoints.

By-time analysis was used to evaluate response at each clinical visit. This method allows clinicians to understand trends in treatment response and can be used to assess progress over time. The Skindex-29 questionnaire was used to assess QOL parameters.

Results at 12 months after treatment was initiated indicated that 44.4% of patients treated with chlormethine, topical corticosteroids plus another therapy had responded, while 45.1% of those treated with chlormethine plus another treatment had responded.

Peak response was reported at 18 months, according to by-time analysis showing that the response rate for chlormethine plus other treatments was 66.7% at this time point.

Other findings revealed a significant correlation between responder status and lower Skindex-29 scores at baseline. Response yielded improvements across subscales of Skindex-29.

Safety data showed no serious treatment-related adverse events associated with chlormethine gel. Pruritus occurred in 9.7% of the cohort, while 7.4% experienced skin irritation and 5% reported erythema.

“This real-world study confirmed that chlormethine gel is an important therapeutic option for patients with mycosis fungoides and contributes to reducing the severity of skin lesions and improving health-related quality of life,” the researchers wrote.