Prospective Study of the Cutaneous Adverse Effects of Sorafenib, a Novel Multikinase Inhibitor

Abstract

To provide an accurate description and to evaluate the incidence and severity of cutaneous reactions induced by sorafenib tosylate, a new oral multikinase inhibitor. Design: Double-blind, prospective dermatologic substudy performed on all consecutive patients included in our center in a large phase 3 trial.

Unusually Severe Bullous Skin Reaction to Sorafenib: A Case Report

“…The severity of HFSR has been delineated by the National Cancer Institute into three grades. Grade one HFSR is characterized by "minimal changes or dermatitis without pain", grade two is described as "skin changes or pain, not interfering with function", and grade three is "ulcerative dermatitis or skin changes with pain interfering with function [3]." Treatment consists of topical therapy such as creams, dose reduction, or treatment discontinuation, usually with resolution of symptoms [1,3].…”

“…However, various hypotheses have been proposed to explain the reaction. These include increased drug delivery to areas with a high concentration of eccrine sweat glands, a dose-dependent direct toxic effect on the skin, and blockade of VEGF and PDGF receptors [3,5].…”

“…First, his cutaneous reaction to sorafenib was a grade 3 reaction; a meta-analysis has estimated the incidence of grade 3 HFSR at 9% among the studied patients with sorafenib-induced HFSR [4]. Also, he had bullous involve- ment of his hands; in the study of 43 patients on sorafenib, only one patient developed bullous lesions [3]. Furthermore, it was interesting to note that, given the severity of the patient's reaction, the HFSR was limited to the hands, with no foot involvement.…”

“…Documented dermatologic complications of sorafenib include facial erythema, subungual splinter hemorrhages, dry skin, pruritis, alopecia, scalp dysesthesia, and the hand-foot skin reaction (HFSR), often characterized by hyperkeratosis, involving the palms and soles. In a small study of 43 patients on sorafenib, more than 90% developed cutaneous symptoms [3].…”

A Case of Sorafenib-induced DRESS Syndrome in Hepatocelluar Carcinoma

“…4 Cutaneous manifestations (e.g., hand-foot skin reaction [HFSR], skin eruption, scalp dysesthesia, subungal splinter hemorrhages, alopecia, and body hair loss), mostly mild to moderate in severity, comprise the commonest side-effects. 1,5 There are a few case reports of Stevens-Johnson syndrome (SJS) or drug reaction (or rash) with eosinophilia and systemic symptoms (DRESS) syndrome.…”