New and emerging drugs for the treatment of advanced cutaneous squamous cell carcinoma

References

• Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012. J Am Acad Dermatol. 2013;68(6):957–966.
   PubMed Web of Science ®Google Scholar
• Yan F, Tillman BN, Nijhawan RI, et al. High-risk cutaneous squamous cell carcinoma of the head and neck: a clinical review. Ann Surg Oncol. 2021 Dec;28(13):9009–9030.
   PubMed Web of Science ®Google Scholar
• Clayman GL, Lee JJ, Holsinger FC, et al. Mortality risk from squamous cell skin cancer. J Clin Oncol. 2005;23(4):759–765.
   PubMed Web of Science ®Google Scholar
• Nehal KS, Bichakjian CK, Longo DL. Update on keratinocyte carcinomas. N Engl J Med. 2018 Jul 26;379(4):363–374.
   PubMed Web of Science ®Google Scholar
• Zelin E, Maronese CA, Dri A, et al. Identifying candidates for immunotherapy among patients with non-melanoma skin cancer: a review of the potential predictors of response. J Clin Med. 2022 Jun 11;11(12):3364.
   PubMed Web of Science ®Google Scholar
• Rogers HW, Weinstock MA, Feldman SR, et al. Incidence estimate of nonmelanoma skin cancer (keratinocyte carcinomas) in the US population, 2012. JAMA Dermatol. 2015;151(10):1081–1086.
   PubMed Web of Science ®Google Scholar
• Tam S, Gross ND. Cutaneous squamous cell carcinoma in immunosuppressed patients. Curr Oncol Rep. 2019;21(9):1–8.
   Web of Science ®Google Scholar
• De Jong E, Lammerts M, Genders R, et al. Update of advanced cutaneous squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2022;36(Suppl 1):6–10.
   PubMed Web of Science ®Google Scholar
• Stratigos AJ, Garbe C, Dessinioti C, et al. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60–82.
   PubMed Web of Science ®Google Scholar
• Zakhem GA, Pulavarty AN, Carucci J, et al. Association of patient risk factors, tumor characteristics, and treatment modality with poor outcomes in primary cutaneous squamous cell carcinoma: a systematic review and meta-analysis. JAMA Dermatol. 2023 Feb 1;159(2):160–171.
   PubMed Web of Science ®Google Scholar
• Dessinioti C, Pitoulias M, Stratigos AJ. Epidemiology of advanced cutaneous squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2022;36(1):39–50.
   PubMed Web of Science ®Google Scholar
• Schmults CD, Karia PS, Carter JB, et al. Factors predictive of recurrence and death from cutaneous squamous cell carcinoma: a 10-year, single-institution cohort study. JAMA Dermatol. 2013 May;149(5):541–547.
   PubMed Web of Science ®Google Scholar
• Tam S, Gross ND. Cutaneous squamous cell carcinoma in immunosuppressed patients. Curr Oncol Rep. 2019 Jul 29;21(9):82.
   PubMed Web of Science ®Google Scholar
• Oncology N. Squamous cell skin cancer (V2.2022) https://www.nccn.org/guidelines2018 [Cited Jul 2022].
   Google Scholar
• Madeleine MM, Patel NS, Plasmeijer EI, et al. Epidemiology of keratinocyte carcinomas after organ transplantation. Br J Dermatol. 2017 Nov;177(5):1208–1216.
   PubMed Web of Science ®Google Scholar
• Fitzmaurice C, Abate D, Abbasi N, et al. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 29 cancer groups, 1990 to 2017: a systematic analysis for the global burden of disease study. JAMA Oncol. 2019 Dec 1;5(12):1749–1768.
   PubMed Web of Science ®Google Scholar
• Burton KA, Ashack KA, Khachemoune A. Cutaneous squamous cell carcinoma: a review of high-risk and metastatic disease. Am J Clin Dermatol. 2016 Oct;17(5):491–508.
   PubMed Web of Science ®Google Scholar
• Schmitt AR, Brewer JD, Bordeaux JS, et al. Staging for cutaneous squamous cell carcinoma as a predictor of sentinel lymph node biopsy results: meta-analysis of American joint committee on cancer criteria and a proposed alternative system. JAMA Dermatol. 2014 Jan;150(1):19–24.
   PubMed Web of Science ®Google Scholar
• Najim M, Cross S, Gebski V, et al. Early-stage squamous cell carcinoma of the lip: the Australian experience and the benefits of radiotherapy in improving outcome in high-risk patients after resection. Head Neck. 2013 Oct;35(10):1426–1430.
   PubMed Web of Science ®Google Scholar
• Raza SM, Ramakrishna R, Weber RS, et al. Nonmelanoma cutaneous cancers involving the skull base: outcomes of aggressive multimodal management. J Neurosurg. 2015 Sep;123(3):781–788.
   PubMed Web of Science ®Google Scholar
• Harris BN, Pipkorn P, Nguyen KNB, et al. Association of adjuvant radiation therapy with survival in patients with advanced cutaneous squamous cell carcinoma of the head and neck. JAMA Otolaryngol Head Neck Surg. 2019 Feb 1;145(2):153–158.
   PubMed Web of Science ®Google Scholar
• Cañueto J, Jaka A, Corchete LA, et al. Postoperative radiotherapy provides better local control and long-term outcome in selective cases of cutaneous squamous cell carcinoma with perineural invasion. J Eur Acad Dermatol Venereol. 2020 May;34(5):1080–1091.
   PubMed Web of Science ®Google Scholar
• Zhang J, Wang Y, Wijaya WA, et al. Efficacy and prognostic factors of adjuvant radiotherapy for cutaneous squamous cell carcinoma: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2021 Sep;35(9):1777–1787.
   PubMed Web of Science ®Google Scholar
• Pêtre A, Pommier P, Brahmi T, et al. Benefit from adjuvant radiotherapy according to the number of risk factors in cutaneous squamous cell carcinoma. Radiother Oncol. 2022;168:53–60.
   PubMed Web of Science ®Google Scholar
• Nottage MK, Lin C, Hughes BG, et al. Prospective study of definitive chemoradiation in locally or regionally advanced squamous cell carcinoma of the skin. Head Neck. 2017 Apr;39(4):679–683.
   PubMed Web of Science ®Google Scholar
• Work G, Invited R, Kim JYS, et al. Guidelines of care for the management of cutaneous squamous cell carcinoma. J Am Acad Dermatol. 2018 Mar;78(3):560–578.
   PubMed Web of Science ®Google Scholar
• Stratigos AJ, Garbe C, Dessinioti C, et al. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: part 2. Treat Eur J Cancer. 2020;Mar 128 83–102.
   PubMed Web of Science ®Google Scholar
• Brash DE, Rudolph JA, Simon JA, et al. A role for sunlight in skin cancer: UV-induced p53 mutations in squamous cell carcinoma. Proc Natl Acad Sci U S A. 1991 Nov 15;88(22):10124–10128.
   PubMed Web of Science ®Google Scholar
• Ziegler A, Jonason AS, Leffellt DJ, et al. Sunburn and p53 in the onset of skin cancer. Nature. 1994;372(6508):773–776.
   PubMed Web of Science ®Google Scholar
• Pickering CR, Zhou JH, Lee JJ, et al. Mutational landscape of aggressive cutaneous squamous cell carcinoma. Clin Cancer Res. 2014 Dec 15;20(24):6582–6592.
   PubMed Web of Science ®Google Scholar
• Yarchoan M, Hopkins A, Jaffee EM. Tumor mutational burden and response rate to PD-1 inhibition. N Engl J Med. 2017 Dec 21;377(25):2500–2501.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication fda.gov2017. MD: Food and Drug Administration. Cited 2022 Jun 24, 2022 Jun 24.
   Google Scholar
• Migden MR, Rischin D, Schmults CD, et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018 Jul 26;379(4):341–351.
   PubMed Web of Science ®Google Scholar
• Migden MR, Khushalani NI, Chang ALS, et al. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294–305.
   PubMed Web of Science ®Google Scholar
• Rischin D, Khushalani NI, Schmults CD, et al. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. J Immunother Cancer. 2021 Aug;9(8). doi: 10.1136/jitc-2021-002757
   PubMed Web of Science ®Google Scholar
• Grob JJ, Gonzalez R, Basset-Seguin N, et al. Pembrolizumab monotherapy for recurrent or metastatic cutaneous squamous cell carcinoma: a single-arm phase II trial (KEYNOTE-629). J Clin Oncol. 2020 Sep 1;38(25):2916–2925.
   PubMed Web of Science ®Google Scholar
• Hughes BGM, Munoz-Couselo E, Mortier L, et al. Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): an open-label, nonrandomized, multicenter, phase II trial. Ann Oncol. 2021;32(10):1276–1285.
   PubMed Web of Science ®Google Scholar
• Rischin D, Khushalani NI, Schmults CD, et al. Phase II study of cemiplimab in patients (pts) with advanced cutaneous squamous cell carcinoma (CSCC): longer follow-up. J Clin Oncol. 2020;38(15_suppl):10018.
   Google Scholar
• Ferrarotto R, Sousa LG, Qing Y, et al. Pembrolizumab in patients with refractory cutaneous squamous cell carcinoma: a phase II trial. Adv Ther. 2021;38(8):4581–4591.
   PubMed Web of Science ®Google Scholar
• Lang R, Koelblinger P, Richtig E, et al. Efficacy and safety of nivolumab for locally advanced or metastatic cutaneous cell carcinoma (NIVOSQUACS trial). J Clin Oncol. 2022;40(16_suppl):9528.
   Web of Science ®Google Scholar
• Martins F, Sofiya L, Sykiotis GP, et al. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol. 2019;16(9):563–580.
   PubMed Web of Science ®Google Scholar
• Gambichler T, Scheel CH, Reuther J, et al. Management of immune-related adverse events in anti-PD-1-treated patients with advanced cutaneous squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2022 Jan;36(Suppl 1):23–28.
   PubMed Web of Science ®Google Scholar
• de Sousa LG, Ferrarotto R. Pembrolizumab in the first-line treatment of advanced head and neck cancer. Expert Rev Anticancer Ther. 2021 Dec;21(12):1321–1331.
   PubMed Web of Science ®Google Scholar
• Fisher J, Zeitouni N, Fan W, et al. Immune checkpoint inhibitor therapy in solid organ transplant recipients: a patient-centered systematic review. J Am Acad Dermatol. 2020 Jun;82(6):1490–1500.
   PubMed Web of Science ®Google Scholar
• Sigismund S, Avanzato D, Lanzetti L. Emerging functions of the EGFR in cancer. Mol Oncol. 2018;12(1):3–20.
   PubMed Web of Science ®Google Scholar
• Corchado-Cobos R, García-Sancha N, González-Sarmiento R, et al. Cutaneous squamous cell carcinoma: from biology to therapy. Int J Mol Sci. 2020;21(8):2956.
   PubMed Web of Science ®Google Scholar
• Maubec E. Update of the management of cutaneous squamous-cell carcinoma. Acta Derm Venereol. 2020 Jun 3;100(11):adv00143.
   PubMedGoogle Scholar
• William WN Jr, Feng L, Ferrarotto R, et al. Gefitinib for patients with incurable cutaneous squamous cell carcinoma: a single-arm phase II clinical trial. J Am Acad Dermatol. 2017 Dec;77(6):1110–1113.e2.
   PubMed Web of Science ®Google Scholar
• Maubec E, Petrow P, Scheer-Senyarich I, et al. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol. 2011;29(25):3419–3426.
   PubMed Web of Science ®Google Scholar
• Gold KA, Kies MS, William WN Jr, et al. Erlotinib in the treatment of recurrent or metastatic cutaneous squamous cell carcinoma: a single‐arm phase 2 clinical trial. Cancer. 2018;124(10):2169–2173.
   PubMed Web of Science ®Google Scholar
• Aboul-Fettouh N, Morse D, Patel J, et al. Immunotherapy and systemic treatment of cutaneous squamous cell carcinoma. Dermatol Pract Concept. 2021 Nov;11(Suppl 2):e2021169S.
   PubMedGoogle Scholar
• Baysal H, De Pauw I, Zaryouh H, et al. Cetuximab-induced natural killer cell cytotoxicity in head and neck squamous cell carcinoma cell lines: investigation of the role of cetuximab sensitivity and HPV status. Br J Cancer. 2020;123(5):752–761.
   PubMed Web of Science ®Google Scholar
• Trodello C, Pepper JP, Wong M, et al. Cisplatin and cetuximab treatment for metastatic cutaneous squamous cell carcinoma: a systematic review. Dermatol Surg. 2017 Jan;43(1):40–49.
   PubMed Web of Science ®Google Scholar
• Dereure O, Missan H, Girard C, et al. 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. Dermatology. 2016;232(6):721–730.
   PubMed Web of Science ®Google Scholar
• Tahara M, Kiyota N, Yokota T, et al. Phase II trial of combination treatment with paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CSPOR-HN02). Ann Oncol. 2018 Apr 1;29(4):1004–1009.
   PubMed Web of Science ®Google Scholar
• Marin-Acevedo JA, Withycombe B, Kim Y, et al. Efficacy of cetuximab after immunotherapy (IO) in advanced cutaneous squamous cell carcinoma (CSCC). J Clin Oncol. 2021;39(15_suppl):9562.
   Web of Science ®Google Scholar
• Pestana RC, Becnel M, Rubin ML, et al. Response rates and survival to systemic therapy after immune checkpoint inhibitor failure in recurrent/metastatic head and neck squamous cell carcinoma. Oral Oncol. 2020;101:104523.
   PubMed Web of Science ®Google Scholar
• Saleh K, Vinches M, Safta I, et al. Taxanes plus cetuximab with or without platinum chemotherapy after progression on immune checkpoint inhibitors in patients with squamous cell carcinoma of the head and neck. J Clin Oncol. 2022;40(16_suppl):6036.
   Google Scholar
• Kurosaki T, Mitani S, Tanaka K, et al. Safety and efficacy of cetuximab-containing chemotherapy after immune checkpoint inhibitors for patients with squamous cell carcinoma of the head and neck: a single-center retrospective study. Anticancer Drugs. 2021 Jan 1;32(1):95–101.
   PubMed Web of Science ®Google Scholar
• Foote M, McGrath M, Guminski A, et al. Phase II study of single-agent panitumumab in patients with incurable cutaneous squamous cell carcinoma. Ann Oncol. 2014;25(10):2047–2052.
   PubMed Web of Science ®Google Scholar
• Petersen ET, Ahmed SR, Chen L, et al. Review of systemic agents in the treatment of advanced cutaneous squamous cell carcinoma. Future Oncol. 2019 Sep;15(27):3171–3184.
   PubMed Web of Science ®Google Scholar
• Lewis CM, Glisson BS, Feng L, et al. A phase II study of gefitinib for aggressive cutaneous squamous cell carcinoma of the head and neck. Clin Cancer Res. 2012 Mar 1;18(5):1435–1446.
   PubMed Web of Science ®Google Scholar
• Jarkowski A 3rd, Hare R, Loud P, et al. Systemic therapy in advanced cutaneous squamous cell carcinoma (CSCC): the roswell park experience and a review of the literature. Am J Clin Oncol. 2016 Dec;39(6):545–548.
   PubMed Web of Science ®Google Scholar
• Cowey CL, Robert NJ, Espirito JL, et al. Clinical outcomes among unresectable, locally advanced, and metastatic cutaneous squamous cell carcinoma patients treated with systemic therapy. Cancer Med. 2020 Oct;9(20):7381–7387.
   PubMed Web of Science ®Google Scholar
• Guthrie TH Jr, Porubsky ES, Luxenberg MN, et al. Cisplatin-based chemotherapy in advanced basal and squamous cell carcinomas of the skin: results in 28 patients including 13 patients receiving multimodality therapy. J Clin Oncol. 1990 Feb;8(2):342–346.
   PubMed Web of Science ®Google Scholar
• Sadek H, Azli N, Wendling JL, et al. Treatment of advanced squamous cell carcinoma of the skin with cisplatin, 5-fluorouracil, and bleomycin. Cancer. 1990 Oct 15;66(8):1692–1696.
   PubMed Web of Science ®Google Scholar
• Khansur T, Kennedy A. Cisplatin and 5-fluorouracil for advanced locoregional and metastatic squamous cell carcinoma of the skin. Cancer. 1991 Apr 15;67(8):2030–2032.
   PubMed Web of Science ®Google Scholar
• Cartei G, Cartei F, Interlandi G, et al. Oral 5-fluorouracil in squamous cell carcinoma of the skin in the aged. Am J Clin Oncol. 2000 Apr;23(2):181–184.
   PubMed Web of Science ®Google Scholar
• Shin DM, Glisson BS, Khuri FR, et al. Phase II and biologic study of interferon alfa, retinoic acid, and cisplatin in advanced squamous skin cancer. J Clin Oncol. 2002 Jan 15;20(2):364–370.
   PubMed Web of Science ®Google Scholar
• Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: management of advanced and high-stage tumors. J Am Acad Dermatol. 2018 Feb;78(2):249–261.
   PubMed Web of Science ®Google Scholar
• Di Nardo L, Pellegrini C, Di Stefani A, et al. Molecular genetics of cutaneous squamous cell carcinoma: perspective for treatment strategies. J Eur Acad Dermatol Venereol. 2020 May;34(5):932–941.
   PubMed Web of Science ®Google Scholar
• Chalmers ZR, Connelly CF, Fabrizio D, et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med. 2017;9(1):34.
   PubMed Web of Science ®Google Scholar
• Ferrarotto R, Amit M, Nagarajan P, et al. Pilot Phase II trial of neoadjuvant immunotherapy in locoregionally advanced, resectable cutaneous squamous cell carcinoma of the head and neck. Clin Cancer Res. 2021 Aug 15;27(16):4557–4565.
   PubMed Web of Science ®Google Scholar
• Gross ND, Miller DM, Khushalani NI, et al. Neoadjuvant cemiplimab for Stage II to IV cutaneous squamous-cell carcinoma. N Engl J Med. 2022 Sep 12;387(17):1557–1568.
   PubMed Web of Science ®Google Scholar
• Thomas S, Kuncheria L, Roulstone V, et al. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer. 2019 Aug 10;7(1):214.
   PubMed Web of Science ®Google Scholar
• Middleton M, Aroldi F, Sacco J, et al. 422 An open-label, multicenter, phase 1/2 clinical trial of RP1, an enhanced potency oncolytic HSV, combined with nivolumab: updated results from the skin cancer cohorts. J Immunother Cancer. 2020;8(Suppl 3):A257–A257.
   Google Scholar
• Clingan PR, Brungs D, Arnold S, et al. Efficacy and safety of cosibelimab, an anti–PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma. J Clin Oncol. 2022;40(16_suppl):9537.
   Web of Science ®Google Scholar
• López-Albaitero A, Ferris RL. Immune activation by epidermal growth factor receptor specific monoclonal antibody therapy for head and neck cancer. Arch Otolaryngol Head Neck Surg. 2007 Dec;133(12):1277–1281.
   PubMedGoogle Scholar
• Sacco AG, Chen R, Worden FP, et al. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):883–892.
   PubMed Web of Science ®Google Scholar
• Eton O, Hsu E, Patel A, et al. 467 Anti-EGFR antibody added to ongoing anti-PD-1 antibody treatment for metastatic cutaneous squamous cell carcinoma of the face: two case reports. J Immunother Cancer. 2020;8(Suppl 3):A284–A286.
   Google Scholar
• Green AK. Challenges in assessing the cost-effectiveness of cancer immunotherapy. JAMA Network Open. 2021 Jan 4;4(1):e2034020.
   PubMed Web of Science ®Google Scholar