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The incidence of locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC) is rising due to increased UV exposure and population ageing. While PD-1 blockade with cemiplimab has markedly improved survival in unresectable or metastatic cSCC, response rates remain limited in immunocompromised patients and in tumors arising in non–UV-exposed areas.
Definitive radiotherapy (RT) achieves local control rates of up to 90–95% and provides rapid symptomatic relief, but its curative potential is limited in extensive or metastatic disease. Pre-clinical data suggest that RT may enhance anti-tumor immunity by increasing tumor antigen release and stimulating immune activation, potentially synergizing with PD-1 blockade. Clinical synergy between RT and immunotherapy (“radioimmunotherapy”) has been demonstrated in melanoma, lung, and head-and-neck cancers, but evidence for cSCC is scarce.
This retrospective multicenter real-world study aims to evaluate overall survival in patients treated with combined RT and cemiplimab compared to standard RT or chemoradiotherapy. Secondary objectives include assessment of progression-free survival, treatment patterns in elderly and immunocompromised populations, and toxicity profiles.
To date, 574 patient cases from 26 German and Austrian skin cancer centers have been collected. Preliminary data suggest improved progression-free survival for patients receiving concurrent RT and PD-1 inhibition with manageable toxicity.