Cutaneous basal cell carcinoma

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If you're looking for cutaneous squamous cell carcinoma regimens, they've been moved to a separate page.
Last updated on 2024-07-23:6 regimens on this page
7 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 - Basal Cell Skin Cancer
**2024: Schmults et al. Basal Cell Skin Cancer, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology EuroPMC
**2016: Bichakjian et al. Basal Cell Skin Cancer, Version 1.2016, NCCN Clinical Practice Guidelines in Oncology EuroPMC
**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===
FDA-recommended dose
Study 	Dates of enrollment	Evidence
Stratigos et al. 2021 (R2810-ONC-1620)	2017-2019 	Phase 2 (RT)
====Immunotherapy====
*Cemiplimab (Libtayo) 350 mg IV once on day 1
21-day cycle for up to 31 cycles
===References===
#R2810-ONC-1620: Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. Epub 2021 May 14. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT03132636
==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 & Paclitaxel (TP)==
===Regimen===
Study 	Dates of enrollment	Evidence
Jefford et al. 2004	1999 	Case report
====Chemotherapy====
*Cisplatin (Platinol) 75 mg/m2 IV once on day 1
*Paclitaxel (Taxol) 135 mg/m2 IV over 3 hours once on day 1
21-day cycles
===References===
# Case report: Jefford M, Kiffer JD, Somers G, Daniel FJ, Davis ID. Metastatic basal cell carcinoma: rapid symptomatic response to cisplatin and paclitaxel. ANZ J Surg. 2004 Aug;74(8):704-5. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==Sonidegib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Migden et al. 2015 (BOLT)	2011-2013 	Randomized Phase 2 (E-RT-de-esc)	Sonidegib; 800 mg	Did not meet primary endpoint of ORR
Note: In this trial, 200 mg was assessed as having a better benefit-to-risk profile than the other tested dose, 800 mg.
====Targeted therapy====
*Sonidegib (Odomzo) 200 mg PO once per day
Continued indefinitely
===References===
# BOLT: Migden MR, Guminski A, Gutzmer R, Dirix L, Lewis KD, Combemale P, Herd RM, Kudchadkar R, Trefzer U, Gogov S, Pallaud C, Yi T, Mone M, Kaatz M, Loquai C, Stratigos AJ, Schulze HJ, Plummer R, Chang AL, Cornélis F, Lear JT, Sellami D, Dummer R. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 2015 Jun;16(6):716-28. Epub 2015 May 14. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01327053
##Update: Lear JT, Migden MR, Lewis KD, Chang ALS, Guminski A, Gutzmer R, Dirix L, Combemale P, Stratigos A, Plummer R, Castro H, Yi T, Mone M, Zhou J, Trefzer U, Kaatz M, Loquai C, Kudchadkar R, Sellami D, Dummer R. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. J Eur Acad Dermatol Venereol. 2018 Mar;32(3):372-381. Epub 2017 Nov 6. link to original article link to PMC article EuroPMC
==Vismodegib monotherapy==
===Regimen variant #1, 18 months===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Tang et al. 2012 (SHH-4685s)	2009-2011 	Randomized Phase 2 (E-esc)	Placebo 	Reduced tumor burden (primary endpoint)
====Targeted therapy====
*Vismodegib (Erivedge) 150 mg PO once per day
18-month course
===Regimen variant #2, indefinite===
Study 	Dates of enrollment	Evidence
Von Hoff et al. 2009 (JHOC-J06131)	2007-2008 	Phase 1, fewer than 20 pts in this dosing cohort
Sekulic et al. 2012 (ERIVANCE BCC)	2009-2010 	Phase 2 (RT)
====Targeted therapy====
*Vismodegib (Erivedge) 150 mg PO once per day
Continued indefinitely
===References===
# JHOC-J06131: Von Hoff DD, LoRusso PM, Rudin CM, Reddy JC, Yauch RL, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Mackey HM, Lum BL, Darbonne WC, Marsters JC Jr, de Sauvage FJ, Low JA. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009 Sep 17;361(12):1164-72. Epub 2009 Sep 2. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00607724
## Update: LoRusso PM, Rudin CM, Reddy JC, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Chang I, Darbonne WC, Graham RA, Zerivitz KL, Low JA, Von Hoff DD. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2502-11. Epub 2011 Feb 7. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC
# ERIVANCE BCC: Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Low JA, Mackey HM, Yauch RL, Graham RA, Reddy JC, Hauschild A. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171-9. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00833417
## Update: Sekulic A, Migden MR, Lewis K, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Dirix L, Hou J, Yue H, Hauschild A; ERIVANCE BCC investigators. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC. J Am Acad Dermatol. 2015 Jun;72(6):1021-6.e8. link to original article EuroPMC
##Update: Sekulic A, Migden MR, Basset-Seguin N, Garbe C, Gesierich A, Lao CD, Miller C, Mortier L, Murrell DF, Hamid O, Quevedo JF, Hou J, McKenna E, Dimier N, Williams S, Schadendorf D, Hauschild A; ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017 May 16;17(1):332. Erratum in: BMC Cancer. 2019 Apr 18;19(1):366. link to original article link to PMC article EuroPMC
# SHH-4685s: Tang JY, Mackay-Wiggan JM, Aszterbaum M, Yauch RL, Lindgren J, Chang K, Coppola C, Chanana AM, Marji J, Bickers DR, Epstein EH Jr. Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med. 2012 Jun 7;366(23):2180-8. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00957229
## Update: Tang JY, Ally MS, Chanana AM, Mackay-Wiggan JM, Aszterbaum M, Lindgren JA, Ulerio G, Rezaee MR, Gildengorin G, Marji J, Clark C, Bickers DR, Epstein EH Jr. Inhibition of the hedgehog pathway in patients with basal-cell nevus syndrome: final results from the multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Dec;17(12):1720-1731. Epub 2016 Nov 10. link to original article EuroPMC
Category:Cutaneous basal cell carcinoma regimens
Category:Disease-specific pages
Category:Non-melanoma skin cancers