Cutaneous basal cell carcinoma

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Section editor
Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA, USA
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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


SITC


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

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 dosing details in manuscript have been reviewed by our editors PubMed


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

21-day cycle for up to 31 cycles

References

  1. 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 abstract have been reviewed by our editors PubMed NCT03132636


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 dosing details in manuscript have been reviewed by our editors PubMed


Cisplatin & Paclitaxel (TP)

Regimen

Study Dates of enrollment Evidence
Jefford et al. 2004 1999 Case report

Chemotherapy

21-day cycles

References

  1. 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 PubMed


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

Continued indefinitely

References

  1. 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 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 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

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

Continued indefinitely

References

  1. 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 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 dosing details in manuscript have been reviewed by our editors link to PMC article PubMed
  2. 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 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
  3. 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 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


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