Cutaneous squamous cell carcinoma

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Last updated on 2024-12-02:6 regimens on this page
8 variants on this page
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==NCCN==
*NCCN Guidelines - Squamous Cell Skin Cancer
**2010: Miller et al. Basal cell and squamous cell skin cancers. EuroPMC
**2007: Miller et al. Basal cell and squamous cell skin cancers. EuroPMC
**2004: Basal cell and squamous cell skin cancers. Clinical practice guidelines in oncology. EuroPMC
==SITC==
*2022: Silk et al. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer link to PMC article EuroPMC
=Neoadjuvant chemotherapy=
==Bleomycin & Cisplatin==
===Regimen===
Study 	Dates of enrollment	Evidence
Denic 1999	1989-1990 	Pilot, fewer than 20 patients reported
Note: The bleomycin was considered a continuous infusion but was interrupted for one hour each day to deliver the cisplatin by the same IV.
====Chemotherapy====
*Cisplatin (Platinol) 20 mg/m2 IV over 60 minutes once per day on days 1 to 4
*Bleomycin (Blenoxane) 20 mg IV over 23 hours once per day on days 1 to 4
21-day cycle for 3 cycles
====Subsequent treatment====
*Surgery
===References===
# Denic S. Preoperative treatment of advanced skin carcinoma with cisplatin and bleomycin. Am J Clin Oncol. 1999 Feb;22(1):32-4. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
=Advanced or metastatic disease, all lines of therapy=
==Cemiplimab monotherapy==
===Regimen variant #1, weight-based dose===
Study 	Dates of enrollment	Evidence 	Efficacy
Migden et al. 2018 (R2810-ONC-1423)	2016-2017 	Phase 1 (RT)	RR (primary endpoint): 50%, 95% CI 30-70
Migden et al. 2018 (R2810-ONC-1540)	2016-2017 	Phase 2 (RT)	RR (primary endpoint): 47%, 95% CI 34-61
Note: this is the dose used in Groups 1 & 2.
====Immunotherapy====
*Cemiplimab (Libtayo) 3 mg/kg IV over 30 minutes once on day 1
14-day cycle for up to 48 cycles (96 weeks)
===Regimen variant #2, fixed-dose===
FDA-recommended dose
Study 	Dates of enrollment	Evidence 	Efficacy
Migden et al. 2018 (R2810-ONC-1540)	2016-2017 	Phase 2 (RT)	RR (primary endpoint): 47%, 95% CI 34-61
Note: this is dose used in Group 3 of the phase 2 trial.
====Immunotherapy====
*Cemiplimab (Libtayo) 350 mg IV over 30 minutes once on day 1
21-day cycle for up to 18 cycles (1 year)
===References===
# R2810-ONC-1423: Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. Epub 2018 Jun 4. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02383212
# R2810-ONC-1540: Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. Epub 2018 Jun 4. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02760498
##Update: Migden MR, Khushalani NI, Chang ALS, Lewis KD, Schmults CD, Hernandez-Aya L, Meier F, Schadendorf D, Guminski A, Hauschild A, Wong DJ, Daniels GA, Berking C, Jankovic V, Stankevich E, Booth J, Li S, Weinreich DM, Yancopoulos GD, Lowy I, Fury MG, Rischin D. 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. Epub 2020 Jan 14. link to original article link to PMC article EuroPMC
##Update: Rischin D, Khushalani NI, Schmults CD, Guminski A, Chang ALS, Lewis KD, Lim AM, Hernandez-Aya L, Hughes BGM, Schadendorf D, Hauschild A, Thai AA, Stankevich E, Booth J, Yoo SY, Li S, Chen Z, Okoye E, Chen CI, Mastey V, Sasane M, Lowy I, Fury MG, Migden MR. 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):e002757. link to original article link to PMC article EuroPMC
==Cetuximab monotherapy==
===Regimen variant #1, weekly, indefinite===
Study 	Dates of enrollment	Evidence	Efficacy
Maubec et al. 2011 (CTXSCC)	2005-10 to 2008-04 	Phase 2 	DCR6wk (primary endpoint): 69%, 95% CI 52-84
====Targeted therapy====
*Cetuximab (Erbitux) as follows:
**Cycle 1: 400 mg/m2 IV once on day 1
**Cycle 2 onwards: 250 mg/m2 IV once on day 1
7-day cycle for at least 6 cycles
===Regimen variant #2, intermittent===
Study 	Evidence
Miller et al. 2010	Case report
====Targeted therapy====
*Cetuximab (Erbitux) 400 mg/m2 IV once on day 1, then 250 mg/m2 IV once per day on days 8, 15, 22
6-month cycles
===References===
# Case report: Bauman JE, Eaton KD, Martins RG. Treatment of recurrent squamous cell carcinoma of the skin with cetuximab. Arch Dermatol. 2007 Jul;143(7):889-92. link to original article EuroPMC
# Case report: Suen JK, Bressler L, Shord SS, Warso M, Villano JL. Cutaneous squamous cell carcinoma responding serially to single-agent cetuximab. Anticancer Drugs. 2007 Aug;18(7):827-9. link to original article EuroPMC
# Case report: Arnold AW, Bruckner-Tuderman L, Zuger C, Itin PH. Cetuximab therapy of metastasizing cutaneous squamous cell carcinoma in a patient with severe recessive dystrophic epidermolysis bullosa. Dermatology. 2009;219(1):80-3. Epub 2009 May 13. link to original article EuroPMC
# Case report: Miller K, Sherman W, Ratner D. Complete clinical response to cetuximab in a patient with metastatic cutaneous squamous cell carcinoma. Dermatol Surg. 2010 Dec;36(12):2069-74. Epub 2010 Oct 11. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC content property of HemOnc.org 
# Case report: Kim S, Eleff M, Nicolaou N. Cetuximab as primary treatment for cutaneous squamous cell carcinoma to the neck. Head Neck. 2011 Feb;33(2):286-8. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC 
# CTXSCC: Maubec E, Petrow P, Scheer-Senyarich I, Duvillard P, Lacroix L, Gelly J, Certain A, Duval X, Crickx B, Buffard V, Basset-Seguin N, Saez P, Duval-Modeste AB, Adamski H, Mansard S, Grange F, Dompmartin A, Faivre S, Mentré F, Avril MF. 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 Sep 1;29(25):3419-26. Epub 2011 Aug 1. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00240682
==Cisplatin & Doxorubicin==
===Regimen===
Study 	Evidence
Guthrie et al. 1990	Case series
====Chemotherapy====
*Cisplatin (Platinol) 75 mg/m2 IV once on day 1
*Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
21-day cycles
===References===
# Case series: Guthrie TH, Porubsky ES. Successful systemic chemotherapy of advanced squamous and basal cell carcinoma of the skin with cis-diamminedichloroplatinum III and doxorubicin. Laryngoscope. 1982 Nov;92(11):1298-9. link to original article EuroPMC
# Case series: Guthrie TH Jr, McElveen LJ, Porubsky ES, Harmon JD. Cisplatin and doxorubicin. An effective chemotherapy combination in the treatment of advanced basal cell and squamous carcinoma of the skin. Cancer. 1985 Apr 15;55(8):1629-32. EuroPMC 
# Case series: Guthrie TH Jr, Porubsky ES, Luxenberg MN, Shah KJ, Wurtz KL, Watson PR. 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):342-6. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==Cisplatin, Interferon alfa-2a, Isotretinoin==
===Regimen===
Study 	Dates of enrollment	Evidence	Efficacy
Shin et al. 2002	1993-1999 	Phase 2 	ORR: 34%
Note: Shin et al. 2002 did not clearly specify whether the interferon alfa used in the trial was 2a or 2b, but based on the details in the paper and the references cited, it is inferred that interferon alfa-2a was used.
====Immunotherapy====
*Interferon alfa-2a (Roferon-A) 5,000,000 units/m2 SC once per day on days 1, 3, 5
====Chemotherapy====
*Isotretinoin (Accutane) 1 mg/kg PO once per day on days 1 to 7
*Cisplatin (Platinol) 20 mg/m2 IV once on day 1
7-day cycles
===References===
# Shin DM, Glisson BS, Khuri FR, Clifford JL, Clayman G, Benner SE, Forastiere AA, Ginsberg L, Liu D, Lee JJ, Myers J, Goepfert H, Lotan R, Hong WK, Lippman SM. 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):364-70. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==Cosibelimab monotherapy==
===Regimen===
FDA-recommended dose
Study 	Dates of enrollment	Evidence 	Efficacy
Awaiting publication (Study CK-301-101)	Not reported 	Phase 2 (RT)	ORR (primary endpoint): 47%, 95% CI 36-59
====Immunotherapy====
*Cosibelimab (Unloxcyt) 1200 mg IV over 60 minutes once on day 1
21-day cycles
===References===
#Study CK-301-101: NCT03212404
==Pembrolizumab monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Efficacy
Grob et al. 2020 (KEYNOTE-629)	2017-10-26 to 2018-06-15	Phase 2 (RT)	ORR (primary endpoint): 34.3%, 95% CI 25.3-44.2
====Immunotherapy====
*Pembrolizumab (Keytruda) 200 mg IV once on day 1
21-day cycle for up to 35 cycles (2 years)
===References===
#KEYNOTE-629: Grob JJ, Gonzalez R, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Zhang P, Gumuscu B, Swaby RF, Hughes BGM. 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. Epub 2020 Jul 16. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT03284424
##Update: Hughes BGM, Munoz-Couselo E, Mortier L, Bratland Å, Gutzmer R, Roshdy O, González Mendoza R, Schachter J, Arance A, Grange F, Meyer N, Joshi A, Billan S, Zhang P, Gumuscu B, Swaby RF, Grob JJ. 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 Oct;32(10):1276-1285. Epub 2021 Jul 20. Erratum in: Ann Oncol. 2022 Aug;33(8):853. link to original article EuroPMC
##HRQoL analysis: Hughes BGM, Mendoza RG, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Chirovsky D, Zhang P, Gumuscu B, Swaby RF, Grob JJ. Health-Related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629. Dermatol Ther (Heidelb). 2021 Oct;11(5):1777-1790. Epub 2021 Sep 23. link to original article link to PMC article EuroPMC
Category:Cutaneous squamous cell carcinoma regimens
Category:Disease-specific pages
Category:Non-melanoma skin cancers