pep005 and Carcinoma-in-Situ

Ingenol mebutate (IM) is a novel drug currently only FDA-approved for the treatment of actinic keratosis. However, it has been extensively used off-label to treat multiple other skin disorders. In recent years, literature has emerged providing evidence for IM’s use as treatment for dermatologic disorders beyond actinic keratosis, including squamous cell carcinoma in situ. Here, we report a case series in which topical 0.05% ingenol mebutate was used to treat squamous cell carcinoma in situ, with five of six patients demonstrating successful results. J Drugs Dermatol. 2021;20(2):169-171. doi:10.36849/JDD.5602.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Carcinoma in Situ; Carcinoma, Squamous Cell; Diterpenes; Female; Follow-Up Studies; Humans; Male; Middle Aged; Off-Label Use; Protein Kinase Inhibitors; Skin; Skin Neoplasms; Treatment Outcome

Actinic keratosis (AK) is an in situ squamous cell carcinoma which is mostly found on sun-damaged skin, and it is prevalent among Caucasians. However, there is a lack of research on evaluating the treatment efficacy of ingenol mebutate (IM) on AK in Asians. This study was intended to analyze the treatment outcomes of IM on AK in Korean patients with regards to clinical, dermoscopic and histopathological aspects. A prospective study on 46 Korean patients who were diagnosed with AK and treated with IM was conducted. Clinically, 80% (24/30) of the patients showed an improvement at 8 weeks. Twenty out of the 30 (66.7%) patients were found to have achieved histopathological clearance. All local skin responses had disappeared at T4 in all patients. Patients with Fitzpatrick skin type III were proven to exhibit better treatment outcomes, both clinically (P = 0.001) and histopathologically (P = 0.001), than those with Fitzpatrick skin type IV. The clinical and histopathological clearance rate of AK with IM in Korean patients was 80% and 66.7%, respectively. The patients with Fitzpatrick skin type IV showed a tendency to have residual AK, histopathologically after treatment with IM. In conclusion, IM could be an effective and safe treatment option on AK in Korean patients. In addition, it would be helpful to carry out a cautious check-up when treating AK with IM in patients with a darker skin color.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma in Situ; Carcinoma, Squamous Cell; Dermoscopy; Diterpenes; Female; Humans; Keratosis, Actinic; Male; Middle Aged; Prospective Studies; Republic of Korea; Skin; Skin Neoplasms; Treatment Outcome