Light emitting fabrics for photodynamic treatment of vulvar primary extramammary Paget's disease

Abstract

Primary Extramammary Paget's disease (EMPD) is a rare cancer that mainly affects the genital region including vulvar and perianal areas.Without treatment, vulvar EMPD progresses and presents always more erythematous and pruritic plaques, which may become ulcerated and erosive. To control disease progression and symptoms usually experienced by patients, surgical excision is the mainstay of treatment. Unfortunately, even after large surgical excision with intra-operative margin control, recurrences are common [1]. For recurrent patients which undergo multiple resections, severe functional and sexual 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) [2]. To date, none of them can be considered as a solid alternative to surgical excision yet [3]. Nonetheless, multiple clinical cases suggest that PDT could provide the opportunity to treat subclinical lesions, and give some relief on patient's symptoms of the disease [4][5][6].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 usually experienced during the illumination procedure that may lead to premature end of treatment [7,8].Resulting from the knowledge of previous works on actinic keratosis of the scalp treatment with PDT, light emitting fabrics (LEF) technology could address both of the hereinbefore described issues [9][10][11][12]. A new medical device based on LEF named PAGETEX® dedicated to illumination of vulvar and perianal areas has been developed. The device delivers a homogeneous red light (635 nm) with a low irradiance during 2h30, for a total fluence of 12 J/cm². The PAGETEX® device is being assessed in a clinical study (NCT03713203) which aims to establish PAGETEX®-PDT efficacy and tolerability.