Latest revision as of 11:32, 13 May 2024

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

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
- 2016: Bichakjian et al. Basal Cell Skin Cancer, Version 1.2016, NCCN Clinical Practice Guidelines in Oncology PubMed
- 2010: Miller et al. Basal cell and squamous cell skin cancers. PubMed
- 2007: Miller et al. Basal cell and squamous cell skin cancers. PubMed
- 2004: Basal cell and squamous cell skin cancers. Clinical practice guidelines in oncology. PubMed

SITC

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

Neoadjuvant chemotherapy

Bleomycin & Cisplatin

Regimen

Study	Evidence
Denic 1999	Pilot, fewer than 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	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 contains dosing details in abstract PubMed 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 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	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 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	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 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 contains dosing details in manuscript 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

Difference between revisions of "Cutaneous basal cell carcinoma"

Latest revision as of 11:32, 13 May 2024

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

Navigation menu

Search

@@ Line 3: / Line 3: @@
 [[#top|Back to Top]]
 </div>
-{| class="wikitable" style="text-align:center; width:50%;"
+{{#lst:Editorial board transclusions|derm}}
-!colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c"|'''Section editor'''
-|-
-|style="background-color:#F0F0F0|[[File:Bethbuchbinder.jpg|frameless|upright=0.3|center]]
-|<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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 <big>If you're looking for [[cutaneous squamous cell carcinoma]] regimens, they've been moved to a separate page.</big>
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 {{TOC limit|limit=3}}
 =Guidelines=
-==[https://www.nccn.org/ NCCN]==
+'''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.'''
-*[https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf NCCN Guidelines - Basal Cell Skin Cancer]
+==NCCN==
+*[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1416 NCCN Guidelines - Basal Cell Skin Cancer]
+**'''2016:''' Bichakjian et al. [https://doi.org/10.6004/jnccn.2016.0065 Basal Cell Skin Cancer, Version 1.2016, NCCN Clinical Practice Guidelines in Oncology] [https://pubmed.ncbi.nlm.nih.gov/27160235/ PubMed]
+**'''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]
+==SITC==
+*'''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]
 =Neoadjuvant chemotherapy=
 ==Bleomycin & Cisplatin {{#subobject:3ba784|Regimen=1}}==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen {{#subobject:58ad71|Variant=1}}===
 {| class="wikitable" style="width: 40%; text-align:center;"
@@ Line 33: / Line 32: @@
 |-
 |[http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=1999&issue=02000&article=00008&type=abstract 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====
 *[[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 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. [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}}==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen {{#subobject:389373|Variant=1}}===
 {| class="wikitable" style="color:white; background-color:#404040"
@@ Line 60: / Line 57: @@
 {| class="wikitable" style="width: 60%; text-align:center;"
 !style="width: 33%"|Study
-!style="width: 33%"|Years of enrollment
+!style="width: 33%"|Dates of enrollment
 !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 |-
 |[https://doi.org/10.1016/s1470-2045(21)00126-1 Stratigos et al. 2021 (R2810-ONC-1620)]
+<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
+|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-281-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
+|-
+|} -->
 |2017-2019
 |style="background-color:#91cf61"|Phase 2 (RT)
 |-
 |}
+<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 protocol''' [https://pubmed.ncbi.nlm.nih.gov/34000246/ PubMed] NCT03132636
+#'''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] [https://clinicaltrials.gov/study/NCT03132636 NCT03132636]
 ==Cisplatin & Doxorubicin {{#subobject:1ab6f6|Regimen=1}}==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen {{#subobject:dd241e|Variant=1}}===
 {| class="wikitable" style="width: 40%; text-align:center;"
@@ Line 87: / Line 86: @@
 |-
 |[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====
 *[[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://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 verified protocol''' [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 & Paclitaxel {{#subobject:c1f84a|Regimen=1}}==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen {{#subobject:a20122|Variant=1}}===
 {| class="wikitable" style="width: 40%; text-align:center;"
@@ Line 111: / Line 106: @@
 !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 |-
-|[https://onlinelibrary.wiley.com/doi/10.1111/j.1445-1433.2004.03130.x/abstract Jefford et al. 2004]
+|[https://doi.org/10.1111/j.1445-1433.2004.03130.x Jefford et al. 2004]
 |style="background-color:#ffffbe"|Retrospective
 |-
 |}
+<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://onlinelibrary.wiley.com/doi/10.1111/j.1445-1433.2004.03130.x/abstract link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/15315581 PubMed]
+# '''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}}==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen {{#subobject:PYV1|Variant=1}}===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates 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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2815%2970100-2/fulltext Migden et al. 2015 (BOLT)]
+|[https://doi.org/10.1016/S1470-2045%2815%2970100-2 Migden et al. 2015 (BOLT)]
 |2011-2013
 |style="background-color:#1a9851"|Randomized Phase 2 (E-RT-de-esc)
@@ Line 144: / Line 135: @@
 |-
 |}
-''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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2815%2970100-2/fulltext link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/25981810 PubMed] NCT01327053
+# '''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. [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] [https://clinicaltrials.gov/study/NCT01327053 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}}==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen variant #1, 18 months {{#subobject:e5e31b|Variant=1}}===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
@@ Line 170: / Line 159: @@
 | style="background-color:#1a9851" |Randomized Phase 2 (E-esc)
 |[[#Placebo|Placebo]]
-| style="background-color:#1a9850" |Reduced tumor burden
+| style="background-color:#1a9850" |Reduced tumor burden (primary endpoint)
 |-
 |}
+<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;"
 !style="width: 33%"|Study
-!style="width: 33%"|Years of enrollment
+!style="width: 33%"|Dates of enrollment
 !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 |-
-|[https://www.nejm.org/doi/full/10.1056/NEJMoa0905360 Von Hoff et al. 2009 (JHOC-J06131)]
+|[https://doi.org/10.1056/NEJMoa0905360 Von Hoff et al. 2009 (JHOC-J06131)]
 |2007-2008
-|style="background-color:#ffffbe"|Phase 1, <20 pts in this dosing cohort
+|style="background-color:#ffffbe"|Phase 1, fewer than 20 pts in this dosing cohort
 |-
 |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278761/ Sekulic et al. 2012 (ERIVANCE BCC)]
@@ Line 193: / Line 183: @@
 |-
 |}
+<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://www.nejm.org/doi/full/10.1056/NEJMoa0905360 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/19726763 PubMed] NCT00607724
+# '''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] [https://clinicaltrials.gov/study/NCT00607724 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. [http://clincancerres.aacrjournals.org/content/17/8/2502.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5244484/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21300762 PubMed]
+## '''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. [https://doi.org/10.1158/1078-0432.CCR-10-2745 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5244484/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21300762/ 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. [https://www.nejm.org/doi/full/10.1056/NEJMoa1113713 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278761/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22670903 PubMed] NCT00833417
+# '''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. [https://doi.org/10.1056/NEJMoa1113713 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278761/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22670903/ PubMed] [https://clinicaltrials.gov/study/NCT00833417 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. [https://www.jaad.org/article/S0190-9622(15)01404-8/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/25981002 PubMed]
+## '''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. [https://doi.org/10.1016/j.jaad.2015.03.021 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25981002/ PubMed]
-##'''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. [https://doi.org/10.1186/s12885-017-3286-5 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5433030/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28511673/ PubMed]
+##'''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. [https://doi.org/10.1186/s12885-017-3286-5 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5433030/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28511673/ 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. [https://www.nejm.org/doi/10.1056/NEJMoa1113538 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4362529/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/22670904 PubMed] NCT00957229
+# '''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] [https://clinicaltrials.gov/study/NCT00957229 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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30566-6/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/27838224 PubMed]
+## '''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]]