Difference between revisions of "Cutaneous squamous cell carcinoma"

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{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
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=Guidelines=
 
=Guidelines=
 
==[https://www.nccn.org/ NCCN]==
 
==[https://www.nccn.org/ NCCN]==
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==SITC==
 
==SITC==
 
*'''2022:''' Silk et al. [http://dx.doi.org/10.1136/jitc-2021-004434 Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer]
 
*'''2022:''' Silk et al. [http://dx.doi.org/10.1136/jitc-2021-004434 Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer]
−
 
 
=Neoadjuvant chemotherapy=
 
=Neoadjuvant chemotherapy=
 
==Bleomycin & Cisplatin {{#subobject:25eb19|Regimen=1}}==
 
==Bleomycin & Cisplatin {{#subobject:25eb19|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:d4d7f3|Variant=1}}===
 
===Regimen {{#subobject:d4d7f3|Variant=1}}===
 
{| class="wikitable" style="width: 40%; text-align:center;"  
 
{| class="wikitable" style="width: 40%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Cisplatin (Platinol)]] 20 mg/m<sup>2</sup> IV once per day on days 1 to 4
 
*[[Cisplatin (Platinol)]] 20 mg/m<sup>2</sup> IV once per day on days 1 to 4
 
*[[Bleomycin (Blenoxane)]] 20 mg IV once per day on days 1 to 4
 
*[[Bleomycin (Blenoxane)]] 20 mg IV once per day on days 1 to 4
−
 
 
'''21-day cycle for 3 cycles'''
 
'''21-day cycle for 3 cycles'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 
====Subsequent treatment====
 
====Subsequent treatment====
 
*[[Surgery#Surgical_resection|Surgery]]
 
*[[Surgery#Surgical_resection|Surgery]]
 +
</div></div>
 
===References===
 
===References===
 
# Denic S. Preoperative treatment of advanced skin carcinoma with cisplatin and bleomycin. Am J Clin Oncol. 1999 Feb;22(1):32-4. [http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=1999&issue=02000&article=00008&type=abstract link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/10025376 PubMed]
 
# Denic S. Preoperative treatment of advanced skin carcinoma with cisplatin and bleomycin. Am J Clin Oncol. 1999 Feb;22(1):32-4. [http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=1999&issue=02000&article=00008&type=abstract link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/10025376 PubMed]
−
 
 
=Adjuvant therapy=
 
=Adjuvant therapy=
 
==Observation==
 
==Observation==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|}
 
|}
 
''No further treatment.''
 
''No further treatment.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#Surgical_resection|Surgical resection]]
 
*[[Surgery#Surgical_resection|Surgical resection]]
 +
</div></div>
 
===References===
 
===References===
 
# 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. [https://doi.org/10.1200/JCO.2006.05.9873 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17513803 PubMed]
 
# 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. [https://doi.org/10.1200/JCO.2006.05.9873 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17513803 PubMed]
−
 
 
==Placebo==
 
==Placebo==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|}
 
|}
 
''No active antineoplastic treatment.''
 
''No active antineoplastic treatment.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#Surgical_resection|Surgical resection]] and [[Regimen_classes#Radiation_therapy|RT]]
 
*[[Surgery#Surgical_resection|Surgical resection]] and [[Regimen_classes#Radiation_therapy|RT]]
 +
</div></div>
 
===References===
 
===References===
 
# '''R2810-ONC-1788:''' NCT03969004
 
# '''R2810-ONC-1788:''' NCT03969004
−
 
 
=Advanced or metastatic disease, all lines of therapy=
 
=Advanced or metastatic disease, all lines of therapy=
−
 
 
==Cemiplimab monotherapy {{#subobject:946331|Regimen=1}}==
 
==Cemiplimab monotherapy {{#subobject:946331|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #1, weight-based dose {{#subobject:f6a63a|Variant=1}}===
 
===Regimen variant #1, weight-based dose {{#subobject:f6a63a|Variant=1}}===
 
{| class="wikitable" style="width: 60%; text-align:center;"  
 
{| class="wikitable" style="width: 60%; text-align:center;"  
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|}
 
|}
 
''Note: this is the dose used in Groups 1 & 2.''
 
''Note: this is the dose used in Groups 1 & 2.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunotherapy====
 
====Immunotherapy====
 
*[[Cemiplimab (Libtayo)]] 3 mg/kg IV over 30 minutes once on day 1
 
*[[Cemiplimab (Libtayo)]] 3 mg/kg IV over 30 minutes once on day 1
−
 
 
'''14-day cycle for up to 48 cycles (96 weeks)'''
 
'''14-day cycle for up to 48 cycles (96 weeks)'''
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2, fixed-dose {{#subobject:389373|Variant=1}}===
 
===Regimen variant #2, fixed-dose {{#subobject:389373|Variant=1}}===
 
{| class="wikitable" style="color:white; background-color:#404040"
 
{| class="wikitable" style="color:white; background-color:#404040"
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|}
 
|}
 
''Note: this is dose used in Group 3 of the phase II trial.''
 
''Note: this is dose used in Group 3 of the phase II trial.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunotherapy====
 
====Immunotherapy====
 
*[[Cemiplimab (Libtayo)]] 350 mg IV over 30 minutes once on day 1
 
*[[Cemiplimab (Libtayo)]] 350 mg IV over 30 minutes once on day 1
−
 
 
'''21-day cycle for up to 18 cycles (1 year)'''
 
'''21-day cycle for up to 18 cycles (1 year)'''
 +
</div></div>
 
===References===
 
===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. [https://doi.org/10.1056/NEJMoa1805131 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29863979 PubMed] NCT02383212
 
# '''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. [https://doi.org/10.1056/NEJMoa1805131 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29863979 PubMed] 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. [https://doi.org/10.1056/NEJMoa1805131 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29863979 PubMed] NCT02760498
 
# '''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. [https://doi.org/10.1056/NEJMoa1805131 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29863979 PubMed] NCT02760498
−
 
 
==Cetuximab monotherapy {{#subobject:5f3411|Regimen=1}}==
 
==Cetuximab monotherapy {{#subobject:5f3411|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #1, weekly, indefinite {{#subobject:f75d12|Variant=1}}===
 
===Regimen variant #1, weekly, indefinite {{#subobject:f75d12|Variant=1}}===
 
{| class="wikitable" style="width: 40%; text-align:center;"  
 
{| class="wikitable" style="width: 40%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Cetuximab (Erbitux)]] as follows:
 
*[[Cetuximab (Erbitux)]] as follows:
 
**Cycle 1: 400 mg/m<sup>2</sup> IV once on day 1
 
**Cycle 1: 400 mg/m<sup>2</sup> IV once on day 1
 
**Cycle 2 onwards: 250 mg/m<sup>2</sup> IV once on day 1
 
**Cycle 2 onwards: 250 mg/m<sup>2</sup> IV once on day 1
−
 
 
'''7-day cycle for at least 6 cycles'''
 
'''7-day cycle for at least 6 cycles'''
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2, weekly x 3 mo {{#subobject:7579ab|Variant=1}}===
 
===Regimen variant #2, weekly x 3 mo {{#subobject:7579ab|Variant=1}}===
 
{| class="wikitable" style="width: 40%; text-align:center;"  
 
{| class="wikitable" style="width: 40%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Cetuximab (Erbitux)]] 400 mg/m<sup>2</sup> IV once, then 250 mg/m<sup>2</sup> IV once per week  
 
*[[Cetuximab (Erbitux)]] 400 mg/m<sup>2</sup> IV once, then 250 mg/m<sup>2</sup> IV once per week  
−
 
 
'''3-month course'''
 
'''3-month course'''
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #3, intermittent {{#subobject:608448|Variant=1}}===
 
===Regimen variant #3, intermittent {{#subobject:608448|Variant=1}}===
 
{| class="wikitable" style="width: 40%; text-align:center;"  
 
{| class="wikitable" style="width: 40%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Cetuximab (Erbitux)]] 400 mg/m<sup>2</sup> IV once on day 1, then 250 mg/m<sup>2</sup> IV once per day on days 8, 15, 22
 
*[[Cetuximab (Erbitux)]] 400 mg/m<sup>2</sup> IV once on day 1, then 250 mg/m<sup>2</sup> IV once per day on days 8, 15, 22
−
 
 
'''6-month cycles'''
 
'''6-month cycles'''
−
 
+
</div></div>
 
===References===
 
===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. [http://archderm.ama-assn.org/cgi/content/full/143/7/889 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17638733 PubMed]
 
# '''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. [http://archderm.ama-assn.org/cgi/content/full/143/7/889 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17638733 PubMed]
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# '''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. [https://doi.org/10.1002/hed.21299 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19953623 PubMed]  
 
# '''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. [https://doi.org/10.1002/hed.21299 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19953623 PubMed]  
 
# '''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. [https://doi.org/10.1200/jco.2010.34.1735 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21810686 PubMed] NCT00240682
 
# '''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. [https://doi.org/10.1200/jco.2010.34.1735 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21810686 PubMed] NCT00240682
−
 
 
==Cisplatin & Doxorubicin {{#subobject:ab12b5|Regimen=1}}==
 
==Cisplatin & Doxorubicin {{#subobject:ab12b5|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:f6ac66|Variant=1}}===
 
===Regimen {{#subobject:f6ac66|Variant=1}}===
 
{| class="wikitable" style="width: 40%; text-align:center;"  
 
{| class="wikitable" style="width: 40%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1
 
*[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1
 
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1
 
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1
−
 
 
'''21-day cycles'''
 
'''21-day cycles'''
−
 
+
</div></div>
 
===References===
 
===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. [https://doi.org/10.1288/00005537-198211000-00014 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6890609 PubMed]
 
# '''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. [https://doi.org/10.1288/00005537-198211000-00014 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6890609 PubMed]
 
# '''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. [https://pubmed.ncbi.nlm.nih.gov/4038911 PubMed]  
 
# '''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. [https://pubmed.ncbi.nlm.nih.gov/4038911 PubMed]  
 
# '''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. [https://doi.org/10.1200/jco.1990.8.2.342 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/2405109 PubMed]
 
# '''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. [https://doi.org/10.1200/jco.1990.8.2.342 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/2405109 PubMed]
−
 
 
==Cisplatin, Interferon alfa-2a, Isotretinoin {{#subobject:74bf3|Regimen=1}}==
 
==Cisplatin, Interferon alfa-2a, Isotretinoin {{#subobject:74bf3|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:399afe|Variant=1}}===
 
===Regimen {{#subobject:399afe|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
−
 
 
''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.''
 
''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.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunotherapy====
 
====Immunotherapy====
 
*[[Interferon alfa-2a (Roferon-A)]] 5,000,000 units/m<sup>2</sup> SC 3 times per week
 
*[[Interferon alfa-2a (Roferon-A)]] 5,000,000 units/m<sup>2</sup> SC 3 times per week
Line 231: Line 233:
 
*[[Isotretinoin (Accutane)]] 1 mg/kg PO once per day
 
*[[Isotretinoin (Accutane)]] 1 mg/kg PO once per day
 
*[[Cisplatin (Platinol)]] 20 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22
 
*[[Cisplatin (Platinol)]] 20 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22
−
 
 
'''28-day cycles'''
 
'''28-day cycles'''
−
 
+
</div></div>
 
===References===
 
===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. [https://doi.org/10.1200/jco.2002.20.2.364 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11786562 PubMed]
 
# 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. [https://doi.org/10.1200/jco.2002.20.2.364 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11786562 PubMed]
−
 
 
==Pembrolizumab monotherapy {{#subobject:74ht14|Regimen=1}}==
 
==Pembrolizumab monotherapy {{#subobject:74ht14|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:ug8afe|Variant=1}}===
 
===Regimen {{#subobject:ug8afe|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunotherapy====
 
====Immunotherapy====
 
*[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1
 
*[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1
−
 
 
'''21-day cycle for up to 35 cycles (2 years)'''
 
'''21-day cycle for up to 35 cycles (2 years)'''
−
 
+
</div></div>
 
===References===
 
===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. [https://doi.org/10.1200/jco.19.03054 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460151/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32673170/ PubMed] NCT03284424
 
#'''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. [https://doi.org/10.1200/jco.19.03054 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460151/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32673170/ PubMed] NCT03284424
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=Investigational agents=
 
=Investigational agents=
 
''Drugs with some degree of promising activity in clinical trials.''
 
''Drugs with some degree of promising activity in clinical trials.''
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[[Category:Cutaneous squamous cell carcinoma regimens]]
 
[[Category:Cutaneous squamous cell carcinoma regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Non-melanoma skin cancers]]
 
[[Category:Non-melanoma skin cancers]]

Revision as of 17:32, 28 February 2023

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Section editor transclusions

6 regimens on this page
9 variants on this page


Guidelines

NCCN

SITC

Neoadjuvant chemotherapy

Bleomycin & Cisplatin

Regimen

Study Evidence
Denic 1999 Pilot, <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 Years 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 Years 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 Years of enrollment Evidence
Migden et al. 2018 (R2810-ONC-1423) 2016-2017 Phase 1 (RT)
Migden et al. 2018 (R2810-ONC-1540) 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 Years of enrollment Evidence
Migden et al. 2018 (R2810-ONC-1540) 2016-2017 Phase 2 (RT)

Note: this is dose used in Group 3 of the phase II 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

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 Non-randomized

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 Years 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 Years of enrollment Evidence
Grob et al. 2020 (KEYNOTE-629) 2017-2018 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

Investigational agents

Drugs with some degree of promising activity in clinical trials.

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