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Ingenol mebutate in the treatment of ‘Hydroxyurea‐induced Squamous Dysplasia’: a single centre experience
Author(s) -
Grandi V.,
Delfino C.,
Pimpinelli N.
Publication year - 2016
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.13616
Subject(s) - medicine , dermatology
Background ‘Hydroxyurea‐induced Squamous Dysplasia’ ( HISD ) is a cutaneous side‐effect related to chronic oral treatment with Hydroxyurea. Ingenol mebutate gel is a topical drug approved for the treatment of multiple, non‐hypertrophic actinic keratoses ( AK ) localized within a limited cancerization field. Since HISD may be considered as a drug‐induced variant of classic AK , ingenol mebutate is likely to have therapeutic effects. Objectives The aim of this study was to evaluate efficacy and safety of ingenol mebutate 150 mcg/g and 500 mcg/g, as a treatment of HISD lesions on face/scalp and trunk/extremities respectively. Methods Seven areas with a mean of lesions of 5.9 ± 1.7 in five patients with HISD were treated. Patients with lesions on face/scalp self‐treated a 25 cm 2 skin affected area with ingenol mebutate gel 150 mcg/g, one tube daily for 3 days. Patients with lesions localized on trunk/extremities treated the same size affected area with ingenol mebutate gel 500 mcg/g, one tube daily for 2 days. Clinical assessment and count of HISD lesions has been performed by an experienced dermatologist at day 0, at day 57, and at time of last feasible follow‐up visit (median 337 days). Safety assessment included the report of all SAE s. Results At 57‐day follow‐up, we observed an overall response rate ( ORR ) – the sum of Complete Responses ( CR ) + Partial Responses ( PR ) – of 87.5%, with a 57.1% CR , and a 78.0% total lesions' reduction compared to time 0 ( P < 0.01). On a median follow‐up of 337 days, we observed a long‐term ORR of 71.4%, a 57.1% CR ratio and a 65.9% total lesions' reduction compared to time 0 ( P = 0.01). No severe (grade 3–4) adverse events have been reported. Conclusion Although obtained in a small case series, these encouraging data lead us to propose ingenol mebutate gel as a possible treatment for HISD .