November 28, 2012
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Mechlorethamine gel effectively treated patients with mycosis fungoides

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A novel 0.02% mechlorethamine hydrochloride gel was effective and safe in treating patients with mycosis fungoides when compared with 0.02% mechlorethamine compounded ointment, according to study results.

In a randomized, observer-masked, multicenter trial, researchers studied 260 patients (median age, 58 years; 59.2% men) with stage IA to IIA mycosis fungoides (MF), the most common cutaneous T-cell lymphoma (CTCL). The patients had not used topical mechlorethamine within 2 years and were naive to topical carmustine therapy. Patients received either 0.02% mechlorethamine gel (n=130) or 0.02% mechlorethamine ointment (n=130), applied once daily for up to 12 months. Tumor response and adverse events were assessed monthly for months 1 through 6 and then bimonthly between months 7 and 12.A patient subset was used to assess serum drug levels. Composite Assessment of Index Lesion Severity (CAILS) measured primary efficacy endpoint.

CAILS showed response rates for mechlorethamine gel compared with ointment were 58.5% vs. 47.7%, with a ratio of gel to ointment response rate of 1.23 (95% CI, 0.97-1.55), meeting the criterion for noninferiority. As a secondary clinical endpoint, response rate for mechlorethamine gel was 46.9% compared with 46.2% for ointment when using the Modified Severity-Weighted Assessment Tool. Mechlorethamine gel displayed superiority over ointment in time-to-response analyses (P<.01). While no serious adverse events were reported, drug-related skin irritation was the reason for approximately 20.3% of the gel-treatment cohort and 17.3% of the ointment-treatment cohort to withdraw from the study. There was no detection of systemic absorption of the medication.

The results “confirm the noninferiority of a novel mechlorethamine, 0.02%, gel in the treatment of MF-CTCL compared with a compounded mechlorethamine, 0.20%, petrolatum ointment,” the researchers concluded. “The findings also corroborate multiple reports and case series … that have affirmed the use of mechlorethamine as an effective topical chemotherapy in MF-CTCL and its inclusion as a frontline therapy in treatment guidelines.”

Disclosure: Stuart R. Lessin, MD, serves as a consultant to Ceptaris Therapeutics.