Difference between revisions of "Cutaneous squamous cell carcinoma"

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!colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c"|'''Section editor'''
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[[#top|Back to Top]]
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|style="background-color:#F0F0F0|[[File:Bethbuchbinder.jpg|frameless|upright=0.3|center]]
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</div>
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|<big>[[User:Bethbuchbinder|Elizabeth Buchbinder, MD]]<br>Dana-Farber Cancer Institute<br>Boston, MA</big><br>[https://www.linkedin.com/in/beth-buchbinder-2a9b994/ LinkedIn]
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{{#lst:Editorial board transclusions|derm}}
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''Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit [[Cutaneous squamous cell carcinoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!''
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{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
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=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==
 +
*[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1465 NCCN Guidelines - Squamous Cell Skin Cancer]
 +
**'''2010:''' Miller et al. [https://doi.org/10.6004/Jnccn.2010.0062 Basal cell and squamous cell skin cancers.] [https://pubmed.ncbi.nlm.nih.gov/20870631/ PubMed]
 +
**'''2007:''' Miller et al. [https://doi.org/10.6004/Jnccn.2007.0045 Basal cell and squamous cell skin cancers.] [https://pubmed.ncbi.nlm.nih.gov/17509254/ PubMed]
 +
**'''2004:''' [https://doi.org/10.6004/Jnccn.2004.0001 Basal cell and squamous cell skin cancers. Clinical practice guidelines in oncology.] [https://pubmed.ncbi.nlm.nih.gov/19777692/ PubMed]
  
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=Guidelines=
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==SITC==
−
==[https://www.nccn.org/ NCCN]==
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*'''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] [https://www.ncbi.nlm.nih.gov/pubmed/35902131 PubMed]
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*[https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf NCCN Guidelines - Squamous Cell 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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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=1999&issue=02000&article=00008&type=abstract Denic 1999]
+
|[https://doi.org/10.1097/00000421-199902000-00008 Denic 1999]
−
|style="background-color:#ffffbe"|Pilot, <20 patients reported
+
|style="background-color:#ffffbe"|Pilot, fewer than 20 patients reported
 
|-
 
|-
 
|}
 
|}
 +
<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 protocol''' [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. [https://doi.org/10.1097/00000421-199902000-00008 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/10025376/ PubMed]
−
 
 
−
=Adjuvant therapy=
 
−
==Observation==
 
−
 
 
−
===Regimen===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1200/JCO.2006.05.9873 Brewster et al. 2007]
 
−
|1996-2002
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|Retinoic acid & IFN
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|-
 
−
|}
 
−
''No further treatment.''
 
−
====Preceding treatment====
 
−
*[[Surgery#Surgical_resection|Surgical resection]]
 
−
===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]
 
−
 
 
 
=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;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1805131 Migden et al. 2018 (R2810-ONC-1423)]
+
|[https://doi.org/10.1056/NEJMoa1805131 Migden et al. 2018 (R2810-ONC-1423)]
 
|2016-2017
 
|2016-2017
 
|style="background-color:#91cf61"|Phase 1 (RT)
 
|style="background-color:#91cf61"|Phase 1 (RT)
 
|-
 
|-
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1805131 Migden et al. 2018 (R2810-ONC-1540)]
+
|[https://doi.org/10.1056/NEJMoa1805131 Migden et al. 2018 (R2810-ONC-1540)]
 +
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-360-1 <span style="color:white;">ESMO-MCBS (4)</span>]'''
 +
|-
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|2016-2017
 
|2016-2017
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|style="background-color:#91cf61"|Phase 2 (RT)
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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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{| class="wikitable" style="width: 60%; text-align:center;"  
 
{| class="wikitable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1805131 Migden et al. 2018 (R2810-ONC-1540)]
+
|[https://doi.org/10.1056/NEJMoa1805131 Migden et al. 2018 (R2810-ONC-1540)]
 +
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-360-1 <span style="color:white;">ESMO-MCBS (4)</span>]'''
 +
|-
 +
|} -->
 
|2016-2017
 
|2016-2017
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|-
 
|-
 
|}
 
|}
−
''Note: this is dose used in Group 3 of the phase II trial.''
+
''Note: this is dose used in Group 3 of the phase 2 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://www.nejm.org/doi/full/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] [https://clinicaltrials.gov/study/NCT02383212 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://www.nejm.org/doi/full/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] [https://clinicaltrials.gov/study/NCT02760498 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. [https://doi.org/10.1016/s1470-2045(19)30728-4 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7771329/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31952975/ PubMed]
 +
##'''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. [https://doi.org/10.1136/jitc-2021-002757 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8382148/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34413166/ PubMed]
  
 
==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 sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://doi.org/10.1200/jco.2010.34.1735 Maubec et al. 2011 (CTXSCC)]
 
|[https://doi.org/10.1200/jco.2010.34.1735 Maubec et al. 2011 (CTXSCC)]
 +
|2005-10 to 2008-04
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
 
|}
 
|}
 +
<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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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://onlinelibrary.wiley.com/doi/10.1002/hed.21299/abstract Kim et al. 2011]
+
|[https://doi.org/10.1002/hed.21299 Kim et al. 2011]
 
|style="background-color:#ffffbe"|Case report
 
|style="background-color:#ffffbe"|Case report
 
|-
 
|-
 
|}
 
|}
 +
<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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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://onlinelibrary.wiley.com/doi/10.1111/j.1524-4725.2010.01786.x/abstract Miller et al. 2010]
+
|[https://doi.org/10.1111/j.1524-4725.2010.01786.x Miller et al. 2010]
 
|style="background-color:#ffffbe"|Case report
 
|style="background-color:#ffffbe"|Case report
 
|-
 
|-
 
|}
 
|}
 +
<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]
−
# '''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. [http://journals.lww.com/anti-cancerdrugs/pages/articleviewer.aspx?year=2007&issue=08000&article=00011&type=abstract link to original article] [https://pubmed.ncbi.nlm.nih.gov/17581306 PubMed]
+
# '''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. [http://journals.lww.com/anti-cancerdrugs/pages/articleviewer.aspx?year=2007&issue=08000&article=00011&type=abstract link to original article] [https://pubmed.ncbi.nlm.nih.gov/17581306/ PubMed]
−
# '''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. [http://content.karger.com/produktedb/produkte.asp?DOI=10.1159/000218714 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19439919 PubMed]
+
# '''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. [http://content.karger.com/produktedb/produkte.asp?DOI=10.1159/000218714 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19439919/ PubMed]
−
# '''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. [https://onlinelibrary.wiley.com/doi/10.1111/j.1524-4725.2010.01786.x/abstract link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21044226 PubMed] content property of [http://hemonc.org HemOnc.org]  
+
# '''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. [https://doi.org/10.1111/j.1524-4725.2010.01786.x link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21044226/ PubMed] content property of [https://hemonc.org 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. [https://onlinelibrary.wiley.com/doi/10.1002/hed.21299/abstract 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] [https://clinicaltrials.gov/study/NCT00240682 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;"  
Line 174: Line 172:
 
|-
 
|-
 
|[https://doi.org/10.1200/jco.1990.8.2.342 Guthrie et al. 1990]
 
|[https://doi.org/10.1200/jco.1990.8.2.342 Guthrie et al. 1990]
−
|style="background-color:#91cf61"|Non-randomized
+
|style="background-color:#ffffbe"|Case series
 
|-
 
|-
 
|}
 
|}
 +
<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://onlinelibrary.wiley.com/doi/abs/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;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
Line 201: Line 199:
 
|-
 
|-
 
|}
 
|}
−
 
 
''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 once per day on days 1, 3, 5
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Isotretinoin (Accutane)]] 1 mg/kg PO once per day
+
*[[Isotretinoin (Accutane)]] 1 mg/kg PO once per day on days 1 to 7
−
*[[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 on day 1
−
 
+
'''7-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;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460151/ Grob et al. 2020 (KEYNOTE-629)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460151/ Grob et al. 2020 (KEYNOTE-629)]
−
|2017-2018
+
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-359-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
 +
|-
 +
|} -->
 +
|2017-10-26 to 2018-06-15
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|-
 
|-
 
|}
 
|}
 +
<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] [https://clinicaltrials.gov/study/NCT03284424 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. [https://doi.org/10.1016/j.annonc.2021.07.008 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34293460/ PubMed]
−
=Investigational agents=
+
##'''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. [https://doi.org/10.1007/s13555-021-00598-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8484388/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34558040/ PubMed]
−
''Drugs with some degree of promising activity in clinical trials.''
 
  
 
[[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]]

Latest revision as of 19:29, 23 June 2024

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Section editor
Bethbuchbinder.jpg
 Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA, USA
LinkedIn

Are you looking for a regimen but can't find it here? For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!

6 regimens on this page
9 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

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

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) 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) 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 Dates of enrollment Evidence
Maubec et al. 2011 (CTXSCC) 2005-10 to 2008-04 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

7-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) 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
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