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	Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA LinkedIn

If you're looking for cutaneous squamous cell carcinoma regimens, they've been moved to a separate page.

6 regimens on this page 7 variants on this page

Guidelines

NCCN

NCCN Guidelines - Basal Cell Skin Cancer

SITC

2022: Silk et al. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer

Neoadjuvant chemotherapy

Bleomycin & Cisplatin

Regimen

Study	Evidence
Denic 1999	Pilot, <20 patients reported

Chemotherapy

Cisplatin (Platinol) 20 mg/m² 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

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 contains dosing details in abstract PubMed

Advanced or metastatic disease, all lines of therapy

Cemiplimab monotherapy

Regimen

FDA-recommended dose

Study	Years 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 contains dosing details in abstract PubMed NCT03132636

Cisplatin & Doxorubicin

Regimen

Study	Evidence
Guthrie et al. 1990	Non-randomized

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 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. 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. link to original article contains dosing details in manuscript PubMed

Cisplatin & Paclitaxel

Regimen

Study	Evidence
Jefford et al. 2004	Retrospective

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

Retrospective: 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 contains dosing details in manuscript PubMed

Sonidegib monotherapy

Regimen

Study	Years 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. link to original article contains dosing details in manuscript PubMed NCT01327053
1. 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 PubMed

Vismodegib monotherapy

Regimen variant #1, 18 months

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Tang et al. 2012 (SHH-4685s)	2009-2011	Randomized Phase 2 (E-esc)	Placebo	Reduced tumor burden

Targeted therapy

Vismodegib (Erivedge) 150 mg PO once per day

18-month course

Regimen variant #2, indefinite

Study	Years of enrollment	Evidence
Von Hoff et al. 2009 (JHOC-J06131)	2007-2008	Phase 1, <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 contains dosing details in manuscript PubMed NCT00607724
1. 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 contains dosing details in manuscript link to PMC article PubMed
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 PubMed NCT00833417
1. 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 PubMed
2. 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 PubMed
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 contains dosing details in manuscript PubMed NCT00957229
1. 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 PubMed

@@ Line 24: / Line 24: @@
 =Neoadjuvant chemotherapy=
 ==Bleomycin & Cisplatin {{#subobject:3ba784|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:58ad71|Variant=1}}===
 {| class="wikitable" style="width: 40%; text-align:center;"
@@ Line 34: / Line 34: @@
 |-
 |}
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Chemotherapy====
 *[[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
 '''21-day cycle for 3 cycles'''
+</div>
+<div class="toccolours" style="background-color:#cbd5e7">
 ====Subsequent treatment====
 *[[Surgery#Surgical_resection|Surgery]]
+</div></div>
 ===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]
 =Advanced or metastatic disease, all lines of therapy=
 ==Cemiplimab monotherapy {{#subobject:946331|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:389373|Variant=1}}===
 {| class="wikitable" style="color:white; background-color:#404040"
@@ Line 63: / Line 64: @@
 |-
 |}
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Immunotherapy====
 *[[Cemiplimab (Libtayo)]] 350 mg IV once on day 1
 '''21-day cycle for up to 31 cycles'''
+</div></div>
 ===References===
 <!-- # '''Abstract:''' Lewis K, Peris K, Sekulic A, et al 428 Interim analysis of Phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma (mBCC) who progressed on or are intolerant to hedgehog inhibitors (HHIs) Journal for ImmunoTherapy of Cancer 2020;8. [https://jitc.bmj.com/content/8/Suppl_3/A260.2 link to abstract] -->
 #'''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. [https://doi.org/10.1016/s1470-2045(21)00126-1 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34000246/ PubMed] NCT03132636
 ==Cisplatin & Doxorubicin {{#subobject:1ab6f6|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:dd241e|Variant=1}}===
 {| class="wikitable" style="width: 40%; text-align:center;"
@@ Line 82: / Line 83: @@
 |-
 |}
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Chemotherapy====
 *[[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
 '''21-day cycles'''
+</div></div>
 ===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 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]
 ==Cisplatin & Paclitaxel {{#subobject:c1f84a|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:a20122|Variant=1}}===
 {| class="wikitable" style="width: 40%; text-align:center;"
@@ Line 104: / Line 104: @@
 |-
 |}
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Chemotherapy====
 *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1
 *[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV over 3 hours once on day 1
 '''21-day cycles'''
+</div></div>
 ===References===
 # '''Retrospective:''' 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. [https://doi.org/10.1111/j.1445-1433.2004.03130.x link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/15315581 PubMed]
 ==Sonidegib monotherapy {{#subobject:PYR1|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen {{#subobject:PYV1|Variant=1}}===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
@@ Line 130: / Line 129: @@
 |-
 |}
-''In this trial, 200 mg was assessed as having a better benefit-to-risk profile than the other tested dose, 800 mg.''
+''Note: In this trial, 200 mg was assessed as having a better benefit-to-risk profile than the other tested dose, 800 mg.''
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Targeted therapy====
 *[[Sonidegib (Odomzo)]] 200 mg PO once per day
 '''Continued indefinitely'''
+</div></div>
 ===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. [https://doi.org/10.1016/S1470-2045%2815%2970100-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25981810 PubMed] 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. [https://doi.org/10.1111/jdv.14542 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5873455/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28846163/ PubMed]
 ==Vismodegib monotherapy {{#subobject:49aef0|Regimen=1}}==
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen variant #1, 18 months {{#subobject:e5e31b|Variant=1}}===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
@@ Line 157: / Line 155: @@
 |-
 |}
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Targeted therapy====
 *[[Vismodegib (Erivedge)]] 150 mg PO once per day
 '''18-month course'''
+</div></div><br>
+<div class="toccolours" style="background-color:#eeeeee">
 ===Regimen variant #2, indefinite {{#subobject:a8bc1b|Variant=1}}===
 {| class="wikitable" style="width: 60%; text-align:center;"
@@ Line 177: / Line 176: @@
 |-
 |}
+<div class="toccolours" style="background-color:#b3e2cd">
 ====Targeted therapy====
 *[[Vismodegib (Erivedge)]] 150 mg PO once per day
 '''Continued indefinitely'''
+</div></div>
 ===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. [https://doi.org/10.1056/NEJMoa0905360 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19726763 PubMed] NCT00607724
@@ Line 190: / Line 189: @@
 # '''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. [https://doi.org/10.1056/NEJMoa1113538 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4362529/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22670904 PubMed] 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. [https://doi.org/10.1016/S1470-2045(16)30566-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27838224 PubMed]
 [[Category:Cutaneous basal cell carcinoma regimens]]
 [[Category:Disease-specific pages]]
 [[Category:Non-melanoma skin cancers]]

Difference between revisions of "Cutaneous basal cell carcinoma"

Revision as of 15:05, 28 February 2023

Contents

Guidelines

NCCN

SITC

Neoadjuvant chemotherapy

Bleomycin & Cisplatin

Regimen

Chemotherapy

Subsequent treatment

References

Advanced or metastatic disease, all lines of therapy

Cemiplimab monotherapy

Regimen

Immunotherapy

References

Cisplatin & Doxorubicin

Regimen

Chemotherapy

References

Cisplatin & Paclitaxel

Regimen

Chemotherapy

References

Sonidegib monotherapy

Regimen

Targeted therapy

References

Vismodegib monotherapy

Regimen variant #1, 18 months

Targeted therapy

Regimen variant #2, indefinite

Targeted therapy

References

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