{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T06:00:54Z","timestamp":1790748054523,"version":"4.1.0"},"reference-count":30,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T00:00:00Z","timestamp":1788307200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T00:00:00Z","timestamp":1788307200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Deutsche Derma Gesell"],"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Objectives<\/jats:title>\n                    <jats:p>Cemiplimab was the first systemic therapy approved for advanced cutaneous squamous cell carcinoma (cSCC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>We report findings from the Italian early access program cohort, comprising 134 patients treated with cemiplimab, with emphasis on late\u2010onset toxicities and long\u2010term clinical outcomes. Late toxicities were defined as treatment\u2010related adverse events (TRAEs) occurring \u2265\u00a06\u00a0months after therapy initiation. Objective response rate (ORR), disease control rate (DCR), progression\u2010free survival (PFS), and overall survival (OS) were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Median PFS was 9\u00a0months. 58 (43.3%) patients experienced progression while 76 (56.7%) maintained a response. Median OS was 21\u00a0months (range 0\u201332), and 67 (50%) patients died. The ORR and DCR were 58.9% and 72.4%, respectively. CR increased from 15% (20 patients) in September 2020 to 19.4% (26 patients) in early 2022. 15 (11.2%) patients had at least one TRAE and 2 of them stopped cemiplimab. Median time to TRAE onset was 12\u00a0months (range 6\u201323); all events resolved after therapy discontinuation, and none of the AEs became chronic.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>With a longer follow\u2010up than that reported in registrational studies and real\u2010world reports, the clinical activity of cemiplimab was confirmed, with a limited incidence of late toxicities. However, some TRAEs may emerge after prolonged treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ddg.70440","type":"journal-article","created":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T09:52:14Z","timestamp":1788342734000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Cemiplimab in cutaneous squamous cell carcinoma: a longer follow\u2010up study focusing on the late toxicities"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1706-656X","authenticated-orcid":false,"given":"Marco","family":"Rubatto","sequence":"first","affiliation":[{"name":"INOC Istituto Nazionale Oncologico Candiolo; IRCCS, Candiolo (TO)  Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Baggi","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, Department of Medical &amp; Surgical Specialties Radiological Sciences &amp; Public Health, University of Brescia, ASST Spedali Civili  Brescia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta","family":"Depenni","sequence":"additional","affiliation":[{"name":"Department of Oncology Modena University Hospital  Modena Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Guida","sequence":"additional","affiliation":[{"name":"Rare Tumors and Melanoma Unit, Istituto Tumori \"Giovanni Paolo II\"  Bari Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo Antonio","family":"Ascierto","sequence":"additional","affiliation":[{"name":"Medical Oncology Department Istituto Nazionale Tumori, IRCCS, Fondazione \u201cG. Pascale,\u201d  Naples Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Queirolo","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology for Melanoma, European Institute of Oncology IRCCS  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ketty","family":"Peris","sequence":"additional","affiliation":[{"name":"Dermatology, Universit\u00e0 Cattolica del Sacro Cuore  Rome Italy"},{"name":"Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Spagnolo","sequence":"additional","affiliation":[{"name":"Medical Oncology 2, IRCCS Ospedale Policlinico San Martino  Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Bianchi","sequence":"additional","affiliation":[{"name":"Dermatologic Unit, Department of Systems Medicine University of Rome Tor Vergata \u2010 School of Medicine and Surgery  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"De Galitiis","sequence":"additional","affiliation":[{"name":"Oncology Department, IDI \u2013 Istituto Dermopatico dell'Immacolata \u2013 IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Zamparini","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, Department of Medical &amp; Surgical Specialties Radiological Sciences &amp; Public Health, University of Brescia, ASST Spedali Civili  Brescia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilaria","family":"Proietti","sequence":"additional","affiliation":[{"name":"Dermatology Unit \u201cDaniele Innocenzi\u201d, Department of Medical\u2010Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino  Terracina Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo","family":"Marconcini","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, AOU Pisana  Pisa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Botticelli","sequence":"additional","affiliation":[{"name":"Department of Radiology Oncology and Human Pathology, Sapienza University of Rome  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vito","family":"Barbieri","sequence":"additional","affiliation":[{"name":"Medical Oncology Unit, Azienda Ospedaliera di Catanzaro Pugliese Ciaccio  Catanzaro Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salvatore","family":"Alfieri","sequence":"additional","affiliation":[{"name":"Medical Oncology Department Fondazione IRCCS \u2010 Istituto Nazionale dei Tumori  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Concetta","family":"Fargnoli","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences and Applied Biotechnology University of L'Aquila; San Salvatore Hospital  Coppito Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcella","family":"Occelli","sequence":"additional","affiliation":[{"name":"Department of Medicine, Clinical Oncology and Translational Research Azienda Ospedaliera Santa Croce and Carle University Teaching Hospital  Cuneo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Fava","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, Section of Dermatology AOU Citt\u00e0 della Salute e della Scienza, University of Turin  Turin Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessio","family":"Capacchione","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, Section of Dermatology AOU Citt\u00e0 della Salute e della Scienza, University of Turin  Turin Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Comunanza","sequence":"additional","affiliation":[{"name":"INOC Istituto Nazionale Oncologico Candiolo; IRCCS, Candiolo (TO)  Italy"},{"name":"Department of Oncology University of Torino  Turin Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Bossi","sequence":"additional","affiliation":[{"name":"Humanitas Cancer Center, IRCCS Humanitas Research Hospital  Rozzano Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pietro","family":"Quaglino","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, Section of Dermatology AOU Citt\u00e0 della Salute e della Scienza, University of Turin  Turin Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,2]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2015.1187"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2012.11.037"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2017.10.007"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/biomedicines5040071"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-14-1768"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-017-12836-z"},{"key":"e_1_2_7_8_1","unstructured":"NCCN guidelines in oncology: squamous cell skin cancer. 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