Cutaneous side effects of combined therapy with sorafenib and pegylated interferon alpha‐2b in metastatic melanoma (phase II DeCOG trial). (23rd July 2013)

• Record Type: Journal Article
• Authors: Degen, Annette; Weichenthal, Michael; Ugurel, Selma; Trefzer, Uwe; Kilian, Katharina; Garbe, Claus; Egberts, Friederike; Poppe, Lìdia Marilia; Hauschild, Axel; Gutzmer, Ralf
• Is Part Of: Journal der Deutschen Dermatologischen Gesellschaft. Volume 11:Number 9(2013)
• Page Start: 846
• Page End: 853
• Publication Date: 2013-07-23
• Subjects: Skin -- Diseases -- Periodicals; Dermatology -- Periodicals; 616.5005
• DOI: 10.1111/ddg.12100
• Languages: English
• ISSNs: 1610-0379

Abstract

<abstract abstract-type="main"> <title>Summary</title> <sec id="ddg12100-sec-0010" sec-type="section"> <title>Background and objectives</title> <p>During a clinical study with combined therapy of sorafenib and pegylated interferon alpha‐2b (SoraPeg study) of the German Dermatologic Oncology Group (ADO/DeCOG), multiple and severe cutaneous side effects were observed. This study sought to analyze these cutaneous side effects, particularly because future studies with combinations of interferon alpha and targeted therapies are planned.</p> </sec> <sec id="ddg12100-sec-0020" sec-type="section"> <title>Patients and methods</title> <p>In a multicenter phase‐II‐DeCOG study (NCT00623402) in 10 dermato‐oncology centers, 55 patients with metastatic melanoma received a combination of sorafenib (2 x 400 mg/day orally) and pegylated interferon alpha‐2b (3 μg/kg body weight 1 x/week subcutaneously). All cutaneous side effects were documented.</p> </sec> <sec id="ddg12100-sec-0030" sec-type="section"> <title>Results</title> <p>Forty‐one patients (74.5 %) developed cutaneous side effects, particularly exanthems (51.2 %), hand‐foot syndrome (36.5 %), alopecia (36.5 %) and pruritus (24.4 %). Due to the cutaneous side effects, dose reductions were required in 10 patients, interruption of therapy in 10 cases and permanent discontinuation of therapy and in one patient with extensive follicular‐cystic lesions. Exanthems were seen more frequently in women (76.2 %) than in men (23.8 %). The occurrence of cutaneous side effects was not correlated with clinical outcome or prognosis.</p> </sec> <sec id="ddg12100-sec-0040" sec-type="section"> <title>Conclusions</title> <p>The combination of sorafenib/pegylated interferon alpha‐2b caused more cutaneous side effects than have been reported for single agents. Despite intensive dermatologic management of the cutaneous side effects 24 % of patients required a dose modification.</p> </sec> </abstract>