Non-melanoma skin cancers (NMSCs) are responsible for 90% of skin cancers in the United Kingdom (UK)1. Cutaneous squamous cell carcinoma (CSCC), a type of non-melanoma skin cancer (NMSC), accounts for approximately 23% of all NMSC cases in the UK and is the cause of 75% of NMSC deaths1-4. Primary CSCCs are typically curable with surgery and/or radiotherapy, however approximately 5% of all CSCCs will advance locally to other areas of the body, or spread5-7.
Advanced CSCC is classified as locally advanced and metastatic, including locoregional metastatic or distant metastatic CSCC8. Advanced disease is typically associated with a poor prognosis8.
Unmet CSCC Needs
Advanced CSCC causes significant morbidity and reduced quality of life due to scarring, disfigurement and aesthetic complications and functional loss9,10,11. When disfigurement is experienced, patients may also struggle with physical and psychosocial issues11. Surgery and/or radiotherapy may be ruled out when patients are likely to face unacceptable complications, morbidity or deformity post-treatment8,12. Rates of metastatic disease in recurrent CSCC vary from 25-45% depending on location of the tumour, with higher rates seen in the head and neck area, including in particular the ear and lip13.
There have historically been limited options for patients unable or unwilling to undergo local treatments12,14. A retrospective study conducted in 2018 showed that 59% of patients diagnosed with locally advanced CSCC and were found ineligible for curative surgery and/or radiotherapy remained untreated15.
Evolving Treatment Landscape
Alternative treatment approaches are required in advanced CSCC when surgery and/or radiotherapy is deemed to be non-curative or would result in disfigurement and loss of function16-18. Patients who are ineligible for curative local treatments may have historically received unlicensed chemotherapy typically associated with short lived responses or best supportive/palliative care19. Studies have demonstrated a median overall survival of 8 – 13 months for patients with locally advanced or metastatic CSCC who are not candidates for curative surgery or radiation20-28.
Within UK clinical practice guidelines, a specialist skin multi-disciplinary team (SSMDT) review of locally advanced and metastatic CSCC presentations is a key recommendation29-32. In the UK, MDT approaches to cancer patient management have been shown to improve patient survival rates in other tumour types (colorectal, oesophageal and head and neck) and overall patient experience of their care33. European clinical practice guidelines further recommend that people with locally advanced or metastatic CSCC who are not candidates for curative surgery or curative radiotherapy should receive first-line treatment with an antibody that inhibits the PD-1/PD-L1 immune checkpoint pathway29.
Sanofi Genzyme Oncology is committed to the management of patients with advanced CSCC. LIBTAYO® ▼ (cemiplimab) is a PD-1 immune checkpoint inhibitor and as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation34.
For more information on European and National guidelines, you may find it useful to visit:
Sanofi and Regeneron are collaborating in a global development programme and commercialisation of Libtayo
1. National Cancer Intelligence Network. Non-melanoma skin cancer in England, Scotland, Northern Ireland, and Ireland. 2013. (Updated: April 2013) Available at: www.ncin.org.uk/publications/data_briefings/non_melanoma_skin_cancer_in_england_scotland_northern_ireland_and_ireland (last accessed June 2021). 2. Newlands C, et al (2016) Non-melanoma skin cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol; 130(2_suppl):S125–32. 3. Didona D, et al (2018) Non-melanoma skin cancer pathogenesis overview. Biomedicines; 6(1):6. 4. NHS England, Skin cancer (non-melanoma). Available from https://www.nhs.uk/conditions/non-melanoma-skin-cancer (last accessed June 2021). 5. Schmults CD, et al (2016) High-risk cutaneous squamous cell carcinoma: A practical guide for patient management: Springer. 6. Mansouri B and Housewright C (2017) The treatment of actinic keratoses—the rule rather than the exception. J Am Acad Dermatol; 153(11):1200. 7. Migden et al (2018) PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. New England Journal of Medicine; 379(4):341-351. 8. Stratigos AJ et al (2020) European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1: epidemiology, diagnostics and prevention. European Journal of Cancer; 128: 60-82. 9. Lomas A et al (2012) A systematic review of worldwide incidence of nonmelanoma skin cancer. British Journal of Dermatology; 166(5): 1069-80 10. Rhee JS et al (2006) Validation of a quality-of-life instrument for patients with non-melanoma skin cancer. Arch Facial Plast Surg; 8(5):314-318. 11. Berens AM et al (2017) Complications in facial Mohs defect reconstruction. Curr Opin Otolaryng ol Head Neck Surg; 25(4), 258-264. 12. Soura E et al (2019) Advanced cutaneous squamous cell carcinoma: how is it defined and what new therapeutic approaches are available? Curr Opin Oncol; 31(5):461–8. 13. Alam M and Ratner D (2001) Cutaneous squamous-cell carcinoma. N Engl J Med; 344:975-983. 14. National Institute for Health and Care Excellence (2019) Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma. Available at: https://www.nice.org.uk/guidance/ta592 (last accessed June 2021). 15. Hillen U et al (2018) Advanced cutaneous squamous cell carcinoma: A retrospective analysis of patient profiles and treatment patterns-Results of a noninterventional study of the DeCOG. European Journal of Cancer; 96:34–43. 16. Potenza C et al (2018) A review of the literature of surgical and nonsurgical treatments of invasive squamous cells carcinoma. BioMed Res Int; 9489163. 17. Ascierto PA and Schadendorf D (2019) Immunotherapy in non-melanoma skin cancer: updates and new perspectives. Drugs Context; 8:212583. 18. Heppt MV et al (2019) Comparison of guidelines for the management of patients with high‐risk and advanced cutaneous squamous cell carcinoma – a systematic review. J Eur Acad Dermatol Venereol JEADV; 33(8_suppl):25–32. 19. Stratigos AJ et al (2015) Diagnosis and treatment of invasive squamous cell carcinoma of the skin: European consensusbased interdisciplinary guideline. European Journal of Cancer. 51(14): 1989-2007 20. Picard A et al (2017) Association of oncogenic mutations in patients with advanced cutaneous squamous cell carcinomas treated with cetuximab. JAMA Dermatol; 153(4):291–8. 21. Gold KA et al (2018) Erlotinib in the treatment of recurrent or metastatic cutaneous squamous cell carcinoma: A single-arm phase 2 clinical trial. Cancer; 15;124(10):2169–73. 22. William WN et al (2017) Gefitinib for patients with incurable cutaneous squamous cell carcinoma: A single-arm phase II clinical trial. J Am Acad Dermatol; 77(6):1110-1113.e2. 23. Bossi P et al (2017) Poster presented at: 53rd American Society of Clinical Oncology Annual Meeting; June 2-6, 2017: Chicago, IL. 24. Foote MC et al (2014) Phase II study of single-agent panitumumab in patients with incurable cutaneous squamous cell carcinoma. Ann Oncol Off J Eur Soc Med Oncol; 25(10):2047–52. 25. Dereure O et al (2016) Efficacy and Tolerance of Cetuximab Alone or Combined with Chemotherapy in Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: An Open Study of 14 Patients Dermatol Basel Switz; 232(6):721–30. 26. Jarowski A et al (2016) Systemic therapy in advanced cutaneous squamous cell carcinoma (CSCC): The Roswell Park experience and a review of the literature. Eur J Am J Clin Oncol; 39(6):545–8. 27. Samstein RM et al (2014) Locally advanced and unresectable cutaneous squamous cell carcinoma: outcomes of concurrent cetuximab and radiotherapy. J Skin Cancer; 284582. 28. Preneau S, et al (2014) Efficacy of cetuximab in the treatment of squamous cell carcinoma. J Dermatol Treat; 25(5):424–7. 29. Stratigos AJ et al (2020) European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 2. Treatment. Eur J Cancer; 128:83–102. 30. Scottish Intercollegiate Guidelines Network (2014) SIGN 140 Management of primary cutaneous squamous cell carcinoma: A national clinical guideline. Available at: https://www.sign.ac.uk/media/1094/ sign140.pdf (last accessed June 2021). 31. Motley RJ et al (2009) Multi-professional guidelines for the management of the patient with primary cutaneous squamous cell carcinoma. Available at: http://www.bad.org.uk/shared/get-file.ashx?id=59&itemtype=document (last accessed June 2021). 32. British Association of Dermatologists (2018) NHS England reform of cancer multidisciplinary team (MDT) meetings: The skin MDT response report. Available at: https://www.bad.org.uk/shared/get-file.ashx?itemtype=document&id=6224 (last accessed June 2021). 33. Taylor C et al (2010) Multidisciplinary team working in cancer: what is the evidence? BMJ; 340:c951. 34. Libtayo Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/10438/smpc (last accessed June 2021).
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