LIGHT EMITTING FABRICS FOR PHOTODYNAMIC TREATMENT OF VULVAR PRIMARY EXTRAMAMMARY PAGET’S DISEASE

摘要

Primary Extramammary Paget’s disease (EMPD) is a rare cancer that mainly affects the genital region including vulvarand perianal areas.Without treatment, vulvar EMPD progresses and presents always more erythematous and pruritic plaques, which maybecome ulcerated and erosive. To control disease progression and symptoms usually experienced by patients, surgicalexcision is the mainstay of treatment. Unfortunately, even after large surgical excision with intra-operative margincontrol, recurrences are common . For recurrent patients which undergo multiple resections, severe functional andsexual alterations are described.Only few data are available on the efficacy of alternative conservative treatments, such as laser ablation, radiotherapy,topical chemotherapy and photodynamic therapy (PDT). To date, none of them can be considered as a solidalternative to surgical excision yet . Nonetheless, multiple clinical cases suggest that PDT could provide theopportunity to treat subclinical lesions, and give some relief on patient’s symptoms of the disease.Unfortunately, the benefits of using photodynamic therapy for vulvar EMPD remains a challenge to demonstrate,because of the inhomogeneous illumination of vulvar and perianal areas, and the extreme pain that patients usuallyexperienced during the illumination procedure that may lead to premature end of treatment .Resulting from the knowledge of previous works on actinic keratosis of the scalp treatment with PDT, light emittingfabrics (LEF) technology could address both of the hereinbefore described issues . A new medical device based onLEF named PAGETEX® dedicated to illumination of vulvar and perianal areas has been developed. The device deliversa homogeneous red light (635 nm) with a low irradiance during 2h30, for a total fluence of 12 J/cm~².The PAGETEX® device is being assessed in a clinical study (NCT03713203) which aims to establish PAGETEX®-PDT efficacy and tolerability.