{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T08:27:43Z","timestamp":1740126463485,"version":"3.37.3"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T00:00:00Z","timestamp":1668038400000},"content-version":"vor","delay-in-days":162,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,3,14]],"date-time":"2022-03-14T00:00:00Z","timestamp":1647216000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100017596","name":"Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte","doi-asserted-by":"publisher","award":["V\u201016703\/68502\/2016\u20102020"],"award-info":[{"award-number":["V\u201016703\/68502\/2016\u20102020"]}],"id":[{"id":"10.13039\/100017596","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,6,1]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Malignant melanoma (MM) is one of the most aggressive forms of skin cancer. The occurrence of MM associated with drug therapy has been described in the literature. However, there is no analysis of a substantial number of validated reports of drug-associated MM.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To analyse a substantial number of validated spontaneous reports of drug-associated MM with regard to the suspected drug and the reported characteristics, and to compare these analyses with those of MM cases occurring in the general population in Germany.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Spontaneous reports of MM associated with drug therapy in Germany were identified in a large adverse drug reaction database (EudraVigilance). These results were then compared with analyses of MMs in the pooled data from a population-based German cancer registry.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The 10 most frequently suspected drugs in the MM reports all target the immune system, with 7 of these being immunosuppressants. The median time to onset to MM diagnosis was 2.0\u2009years. Patients with drug-associated MM were 11\u2009years (median) younger than patients with MM in the cancer registry, and this age difference was greater for female than for male patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our results emphasize the importance of regular dermatological examinations of patients being treated with immunosuppressants. Physicians should be aware that in these patients, MM might be detected at younger ages and even within 2\u2009years after initiating therapy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ced.15091","type":"journal-article","created":{"date-parts":[[2022,1,7]],"date-time":"2022-01-07T14:39:18Z","timestamp":1641566358000},"page":"1078-1087","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Descriptive analysis of 179 German reports of melanoma reported to an adverse drug reaction database as a drug-related adverse effect, and comparison with melanoma cases contained in German cancer registries"],"prefix":"10.1093","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8260-0891","authenticated-orcid":false,"given":"Bernhardt","family":"Sachs","sequence":"first","affiliation":[{"name":"Research Department Federal Institute for Drugs and Medical Devices Bonn Germany"},{"name":"Department for Dermatology and Allergy University Hospital Aachen Aachen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8763-051X","authenticated-orcid":false,"given":"Diana","family":"Dubrall","sequence":"additional","affiliation":[{"name":"Research Department Federal Institute for Drugs and Medical Devices Bonn Germany"},{"name":"Institute for Medical Biometry, Informatics and Epidemiology University Hospital of Bonn Bonn Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Kraywinkel","sequence":"additional","affiliation":[{"name":"Cente for Cancer Registry Data Robert Koch Institute Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3296-4456","authenticated-orcid":false,"given":"Maike","family":"Schulz","sequence":"additional","affiliation":[{"name":"Central Research Institute of Ambulatory Health Care in Germany Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0788-0317","authenticated-orcid":false,"given":"Matthias","family":"Schmid","sequence":"additional","affiliation":[{"name":"Institute for Medical Biometry, Informatics and Epidemiology University Hospital of Bonn Bonn Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2843-4196","authenticated-orcid":false,"given":"Jens","family":"Bate","sequence":"additional","affiliation":[{"name":"Research Department Federal Institute for Drugs and Medical Devices Bonn Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wilma","family":"Fischer-Barth","sequence":"additional","affiliation":[{"name":"Research Department Federal Institute for Drugs and Medical Devices Bonn Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2022,6,1]]},"reference":[{"key":"2023022412435155000_","first-page":"1071","article-title":"Cutaneous melanoma: from pathogenesis to therapy (Review)","volume":"52","author":"Leonardi","year":"2018","journal-title":"Int J Oncol"},{"key":"2023022412435155000_","doi-asserted-by":"crossref","first-page":"1272","DOI":"10.1111\/jdv.15322","article-title":"Time trends in incidence and mortality of cutaneous melanoma in Germany","volume":"33","author":"Garbe","year":"2019","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2023022412435155000_","doi-asserted-by":"crossref","first-page":"3","DOI":"10.15586\/codon.cutaneousmelanoma.2017.ch1","volume-title":"Cutaneous Melanoma: Etiology and Therapy","author":"Matthews","year":"2017"},{"volume-title":"Zentrum f\u00fcr Krebsregisterdaten. 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