Cutaneous squamous cell carcinoma

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Section editor
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 Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA, USA
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6 regimens on this page
9 variants on this page


Guidelines

NCCN

SITC

Neoadjuvant chemotherapy

Bleomycin & Cisplatin

Regimen

Study Evidence
Denic 1999 Pilot, fewer than 20 patients reported

Chemotherapy

21-day cycle for 3 cycles

Subsequent treatment

References

  1. 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 contains dosing details in abstract PubMed

Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Brewster et al. 2007 1996-2002 Phase 3 (C) Retinoic acid & IFN Did not meet primary endpoint of TTR or SPT

No further treatment.

Preceding treatment

References

  1. Brewster AM, Lee JJ, Clayman GL, Clifford JL, Reyes MJ, Zhou X, Sabichi AL, Strom SS, Collins R, Meyers CA, Lippman SM. Randomized trial of adjuvant 13-cis-retinoic acid and interferon alfa for patients with aggressive skin squamous cell carcinoma. J Clin Oncol. 2007 May 20;25(15):1974-8. link to original article PubMed

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (R2810-ONC-1788) 2019-2025 Phase 3 (C) Cemiplimab TBD

No active antineoplastic treatment.

Preceding treatment

References

  1. R2810-ONC-1788: NCT03969004

Advanced or metastatic disease, all lines of therapy

Cemiplimab monotherapy

Regimen variant #1, weight-based dose

Study Dates of enrollment Evidence
Migden et al. 2018 (R2810-ONC-1423) 2016-2017 Phase 1 (RT)
Migden et al. 2018 (R2810-ONC-1540)
ESMO-MCBS (4)
2016-2017 Phase 2 (RT)

Note: this is the dose used in Groups 1 & 2.

Immunotherapy

14-day cycle for up to 48 cycles (96 weeks)


Regimen variant #2, fixed-dose

FDA-recommended dose
Study Dates of enrollment Evidence
Migden et al. 2018 (R2810-ONC-1540)
ESMO-MCBS (4)
2016-2017 Phase 2 (RT)

Note: this is dose used in Group 3 of the phase 2 trial.

Immunotherapy

21-day cycle for up to 18 cycles (1 year)

References

  1. 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 contains dosing details in manuscript PubMed NCT02383212
  2. 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 contains dosing details in manuscript PubMed NCT02760498
    1. 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 PubMed
    2. 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 PubMed

Cetuximab monotherapy

Regimen variant #1, weekly, indefinite

Study Evidence
Maubec et al. 2011 (CTXSCC) Phase 2

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, weekly x 3 mo

Study Evidence
Kim et al. 2011 Case report

Targeted therapy

3-month course


Regimen variant #3, 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

  1. 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 PubMed
  2. 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 PubMed
  3. 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 PubMed
  4. 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 contains dosing details in manuscript PubMed content property of HemOnc.org
  5. 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 contains dosing details in manuscript PubMed
  6. 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 contains dosing details in manuscript PubMed NCT00240682

Cisplatin & Doxorubicin

Regimen

Study Evidence
Guthrie et al. 1990 Case series

Chemotherapy

21-day cycles

References

  1. 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 PubMed
  2. 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. PubMed
  3. 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 contains dosing details in manuscript PubMed

Cisplatin, Interferon alfa-2a, Isotretinoin

Regimen

Study Dates of enrollment Evidence
Shin et al. 2002 1993-1999 Phase 2

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

Chemotherapy

28-day cycles

References

  1. 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 contains dosing details in manuscript PubMed

Pembrolizumab monotherapy

Regimen

Study Dates of enrollment Evidence
Grob et al. 2020 (KEYNOTE-629)
ESMO-MCBS (3)
2017-10-26 to 2018-06-15 Phase 2 (RT)

Immunotherapy

21-day cycle for up to 35 cycles (2 years)

References

  1. 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 contains dosing details in manuscript link to PMC article PubMed NCT03284424
    1. 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 PubMed
    2. 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 PubMed

Investigational agents

Drugs with some degree of promising activity in clinical trials.

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