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Soo Park, MD
Soo Park, MD
Posted: Monday, August 22, 2022
A light-activated topical ointment may prove to be an effective treatment of mycosis fungoides (cutaneous T-cell lymphoma). Results of the 169-patient, randomized, double-blind phase III FLASH trial, published in JAMA Dermatology, indicate this nonmutagenic photodynamic therapy was not only effective but also yielded a favorable short-term—and potentially long-term—safety profile.
Brian Poligone, MD, PhD, of Rochester Skin Lymphoma Medical Group, Fairport, New York, and colleagues employed topical synthetic hypericin ointment (0.25%) in the multicenter trial. All patients had early-stage (IA–IIA) disease. In cycle 1, patients were randomly assigned 2:1 to receive hypericin or placebo. After 6 weeks of treatment to three index lesions, hypericin was reported to be more effective (index lesion response rate of 16% vs. 4%; P = .04). After cycle 2, in which all patients received hypericin, the index lesion response rate increased to 40% (P < .001 vs. cycle 1 hypericin) and to 49% after cycle 3, in which patients had the option to continue treatment to both the index and additional lesions (P < .001 vs. cycle 1 hypericin).
No serious drug-related adverse effects occurred, noted Dr. Poligone and co-investigators; the most common adverse effects were mild local skin and application-site reactions. Further, both patch- and plaque-type lesions responded similarly to the therapy. In addition, no differences in effectiveness were seen regardless of patient age, sex, race, stage IA versus IB, time since diagnosis, or number of prior therapies.
This type of lymphoma “requires long-term disease management,” the authors pointed out. Current skin-directed therapies are often associated with “short- and/or long-term adverse effects…and waning efficacy, so these findings are an important contribution to [patients’] care.”
Disclosure: The study authors’ disclosure information can be found at JAMAnetwork.com.
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