Cutaneous basal cell carcinoma

Section editor
	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

Neoadjuvant chemotherapy

Bleomycin & Cisplatin

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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

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 protocol PubMed

Advanced or metastatic disease, all lines of therapy

Cisplatin & Doxorubicin

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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

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 verified protocol PubMed

Cisplatin & Paclitaxel

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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

1. 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 verified protocol PubMed

Sonidegib monotherapy

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Regimen

Study	Evidence	Comparator
Migden et al. 2015 (BOLT)	Randomized Phase II (E-RT)	Sonidegib 800 mg

In this trial, 200 mg was assessed as having a better benefit-to-risk profile than the other tested dose, 800 mg.

Chemotherapy

• Sonidegib (Odomzo) 200 mg PO once per day

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. link to original article contains verified protocol PubMed

Vismodegib monotherapy

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Variant #1, 18 months

Study	Evidence	Comparator	Comparative Efficacy
Tang et al. 2012 (SHH-4685s)	Randomized Phase II (E)	Placebo	Reduced tumor burden

Chemotherapy

• Vismodegib (Erivedge) 150 mg PO once per day

18-month course

Variant #2, indefinite

Study	Evidence
Von Hoff et al. 2009 (JHOC-J06131)	Phase 1, <20 pts in this dosing cohort
Sekulic et al. 2012 (ERIVANCE BCC)	Non-randomized (RT)

Chemotherapy

• Vismodegib (Erivedge) 150 mg PO once per day

Continued indefinitely

References

1. Phase I: 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 verified protocol PubMed
   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 verified protocol 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 PubMed
   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
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 contains verified protocol PubMed
   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