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Adobe illustrator 2021 eado12/8/2023 The aim of these Swiss recommendations is to provide Swiss physicians with accepted, evidence-based decision support for the selection and implementation of systemic therapy in patients with locally advanced or distant metastatic cSCC. 10–12 A systematic review of clinical studies with regard to efficacy, side effects and sustainability of therapeutic methods used in Swiss practice is therefore warranted. 3 Recent studies with immune checkpoint inhibitors, also called programmed cell death protein 1 (PD-1) inhibitors, have yielded promising outcomes in advanced cSCC with approximately 50% objective response rates (ORR), and have led to the FDA, EMA and Swissmedic approval of the anti-PD-1 monoclonal antibody cemiplimab for unresectable high-risk cSCC. 7–9 There are several major classes of systemic agents used to treat patients, including immunotherapy, anti-epidermal growth factor receptor (EGFR) therapy, and chemotherapy. In Switzerland, there is currently no consensus first-line systemic treatment for patients who have locally advanced cSCC (lacSCC) or distant metastatic disease (mcSCC). 5 The rising incidence together with the non-negligible patient and economic burden and mortality rate highlights the importance and the clinical relevance of treatments for advanced cSCC. 3 Switzerland has one of the highest incidences of NMSC in Europe, 4 with an estimated 25,000 patients per year affected. 1,2 To date, approximately 20% of all non-melanoma skin cancers (NMSCs) that arise each year can be attributed to cSCC, and 2–5% of these will ultimately metastasize. The incidence of cutaneous squamous cell carcinoma (cSCC) is rising due to the increased longevity of at-risk patients. These up-to-date recommendations will also help Swiss physicians in their decision-making and address treatment variability in Swiss clinical practice. These Swiss recommendations provide guidance for the management of patients aged ≥18 years with lacSCC or mcSCC, specifically systemic therapy with a PD-1 inhibitor in the first-line setting. Difficult-to-treat advanced cSCC patients should be referred to and treated by specialized centers. For classification and optimal management of patients with lacSCC or mcSCC, an interdisciplinary tumor board discussion should be mandatory. Based on the latest evidence from randomized clinical trials, national consensus recommendations for the systemic treatment of advanced cSCC have been defined. While both programmed death-1 (PD-1) receptor inhibitors cemiplimab and pembrolizumab are approved by the FDA, cemiplimab is the only approved systemic therapy for the treatment of nonresectable advanced cSCC in the EU and was recently also approved in Switzerland. Recent evidence from studies with checkpoint immunotherapy has changed the systemic treatment landscape for lacSCC and mcSCC patients. While the majority of cSCC cases are low-grade tumors with an excellent prognosis following surgical excision, a minority of cSCC lesions (approximately 5% of patients) progress to locally advanced cSCC (lacSCC) or distant metastatic disease (mcSCC), both of which have an unfavorable prognosis. Its incidence has been rising in recent years, with the highest rate reported in Switzerland compared to other countries in Europe. Cutaneous squamous cell carcinoma (cSCC) is the second most frequent type of non-melanoma skin cancer.
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