NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

Basal Cell Skin Cancer

Version 3.2024 — March 1, 2024

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Basal Cell Skin Cancer Discussion

*Jeremy Bordeaux, MD, MPH/Chair ϖ Karthik Ghosh, MD Þ Jason Rich, MD ζ

Case Comprehensive Cancer Center/University Mayo Clinic Comprehensive Cancer Center Siteman Cancer Center at Barnes-Jewish Hospital and
Hospitals Seidman Cancer Center and Kelly Harms, MD, PhD ϖ Washington University School of Medicine
Cleveland Clinic Taussig Cancer Institute University of Michigan Rogel Cancer Center Ashok R. Shaha, MD ¶
*Rachel Blitzblau, MD, PhD/Vice Chair § Alan L. Ho, MD, PhD † Memorial Sloan Kettering Cancer Center
Duke Cancer Institute Memorial Sloan Kettering Cancer Center Divya Srivastava, MD ϖ
Sumaira Z. Aasi, MD ϖ John Nicholas Lukens, MD § UT Southwestern Simmons Comprehensive Cancer
Stanford Cancer Institute Abramson Cancer Center at the Center
Murad Alam, MD, MBA, MSCI ϖ ¶ ζ University of Pennsylvania Valencia Thomas, MD ϖ
Robert H. Lurie Comprehensive Susan Manber ¥ The University of Texas MD Anderson Cancer Center
Cancer Center of Northwestern University Publicis Health Courtney Tomblinson, MD ф
Arya Amini, MD § Lawrence Mark, MD, PhD ϖ Vanderbilt-Ingram Cancer Center
City of Hope National Medical Center Indiana University Melvin and Puja Venkat, MD §
Kristin Bibee, MD, PhD ϖ Bren Simon Comprehensive Cancer Center UCLA Jonsson Comprehensive Cancer Center
The Sidney Kimmel Comprehensive Theresa Medina, MD † Yaohui Gloria Xu, MD, PhD ϖ Ÿ
Cancer Center at Johns Hopkins University of Colorado Cancer Center University of Wisconsin Carbone Cancer Center
Diana Bolotin, MD, PhD ϖ Kishwer S. Nehal, MD ϖ Siegrid Yu, MD ϖ
The UChicago Medicine Comprehensive Memorial Sloan Kettering Cancer Center UCSF Helen Diller Family
Cancer Center Comprehensive Cancer Center
Paul Nghiem, MD, PhD ϖ
Pei-Ling Chen, MD, PhD ≠ Fred Hutchinson Cancer Center Mehran Yusuf, MD §
Moffitt Cancer Center O’Neal Comprehensive Cancer Center at UAB
Kelly Olino, MD ¶
Carlo M. Contreras, MD ¶ Yale Cancer Center/Smilow Cancer Hospital
The Ohio State University NCCN
Comprehensive Cancer Center - James Cancer Soo Park, MD † Sara Espinosa, PhD
Hospital and Solove Research Institute UC San Diego Moores Cancer Center Beth McCullough, RN, BS
Dominick DiMaio, MD ≠ Tejesh Patel, MD ϖ
Fred & Pamela Buffett Cancer Center University of Tennessee ϖ Dermatology
Health Science Center ф Diagnostic/Interventional radiology
Jessica M. Donigan, MD ϖ ¶ ‡ Hematology/Hematology oncology
Huntsman Cancer Institute at the Igor Puzanov, MD, MSCI ‡ Þ Internal medicine
University of Utah Roswell Park Comprehensive Cancer Center † Medical oncology
ζ Otolaryngology
Jeffrey M. Farma, MD ¶ ≠ Pathology/Dermatopathology
Fox Chase Cancer Center ¥ Patient advocacy
Continue Ÿ Reconstructive surgery
§ Radiotherapy/Radiation oncology
NCCN Guidelines Panel Disclosures ¶ Surgery/Surgical oncology
* Discussion Section Writing Committee
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Basal Cell Skin Cancer Discussion

NCCN Basal Cell Skin Cancer Panel Members

Summary of the Guidelines Updates Clinical Trials: NCCN believes that
the best management for any patient
Clinical Presentation, Workup, Risk Status, and Staging (BCC-1) with cancer is in a clinical trial.
Treatment for Low-Risk BCC (BCC-2) Participation in clinical trials is
Treatment for High-Risk BCC (BCC-3) especially encouraged.
Treatment for Advanced BCC (BCC-4)
Follow-up and Recurrence (BCC-5) Find an NCCN Member Institution:
https://www.nccn.org/home/member-
Principles of Pathology (BCC-A) institutions.
Stratification to Determine Treatment Options for Local BCC Based on Risk Factors for Recurrence (BCC-B)
NCCN Categories of Evidence and
Principles of Treatment (BCC-C)
Principles of Radiation Therapy (BCC-D) Consensus: All recommendations
Principles of Systemic Therapy (BCC-E) are category 2A unless otherwise
Principles of Cancer Risk Assessment and Counseling (BCC-F) indicated.
See NCCN Categories of Evidence
Abbreviations (ABBR-1) and Consensus.

The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to
treatment. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual
clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations
or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way. The NCCN
Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and the illustrations herein may not
be reproduced in any form without the express written permission of NCCN. ©2024.
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NCCN Guidelines Version 3.2024 NCCN Guidelines Index

Table of Contents
Basal Cell Skin Cancer Discussion

Terminologies in all NCCN Guidelines are being actively modified to advance the goals of equity, inclusion, and representation.
Updates in Version 3.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 2.2024 include:
BCC-3
• Primary Treatment, top option revised: Mohs or other forms of PDEMA (preferred for BCCs that are either recurrent, ≥1 cm, in H zone, recurrent, or ≥1
cm with an aggressive histologic subtype).

September 14, 2023 - Category correction for Version 1.2024

BCC-2
• Primary Treatment, Non-surgical modalities for tumors clinically and histologically consistent with superficial BCC (without dermal extension):
Third bullet, Photodynamic therapy, porfimer sodium was revised from category 2A to category 2B.

Updates in Version 2.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2024 include:
BCC-1
• Footnote g revised: Imaging modality and targeted area should be at the discretion of the treating team based on the suspected extent of disease (ie,
local, regional, metastatic). Histologic confirmation is often sufficient to diagnose local recurrence, but MRI with and without contrast can be considered
to assess extent of local disease. . .
BCC-2
• Primary Treatment, Non-surgical modalities for tumors clinically and histologically consistent with superficial BCC (without dermal extension), third bullet
revised: Photodynamic thearpy (eg, topical aminolevulinic acid [ALA], porfimer sodium [category 2B]) (Useful in Certain Circumstances).
BCC-C
• Second bullet revised: Surgical approaches often offer the most effective and efficient means for accomplishing cure, but considerations of function,
cosmesis, and patient preference may lead to choosing RT/topical therapy/systemic therapy as primary treatment in order to achieve satisfactory
optimal overall results.
• Fourth bullet revised: In patients with superficial basal cell skin cancer, non-surgical modalities therapies such as topical imiquimod, topical 5-FU,
photodynamic therapy (eg, ALA, porfimer sodium),a or cryotherapy may be considered. (See BCC-2)
BCC-E 1 of 2
• None added to Preferred Regimens for Locally Advanced Disease - Neoadjuvant, Locally Advanced Disease, Nodal Disease, and Metastatic Disease.
MS-1
• The Discussion section has been updated to reflect the changes in the algorithm.

Updates in Version 1.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2023 include:
Global changes:
• Extracapsular extension (ECE) changed to extranodal extension (ENE).
BCC-1
• Preliminary Workup, third bullet revised: Shave excision removal if applicable.
• Risk Status, new option added: Locally advanced disease.
• New header added: Staging.
Following High risk, option revised: Consider imaging if clinical exam insufficient for following determining disease extent.
Following Locally advanced disease, option added: Consider imaging to determine disease extent. Continued

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Basal Cell Skin Cancer Discussion

Updates in Version 1.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2023 include:
BCC-1 (continued)
• New header added: Primary Treatment
Following Low risk, option revised: Primary Treatment of Low Risk BCC (BCC-2).
Following High risk, Consider imaging if clinical exam insufficient for determining disease extent, option revised: Primary Treatment of High Riks BCC
(BCC-3).
Following Locally advanced disease, Consider imaging to determine disease extent, option added: BCC-4.
Following Initial presentation of regional or distant metastatic disease, Imaging studies of areas of interest as indicated for suspicion of extensive
disease, option revised: Treatment for Recurrence or Advanced Disease (BCC-4).
• New footnote c added: Morgan FC, et al. J Am Acad Dermatol 2021;85:582-587.
• Footnotes revised:
Footnote d: Extensive disease includes deep involvement such as bone, named nerves, and deep soft tissue. If disease of named nerve(s) is
suspected, MRI with and without contrast is preferred. If bone disease is suspected, CT with contrast is preferred unless contraindicated.
Footnote f: For rare cases that present with regional or distant metastatic disease at diagnosis, treat as per nodal or distant metastases metastatic
pathways on BCC-4.
• Footnote removed: For more information, See American Academy of Dermatology Association.
BCC-2
• Primary Treatment, options revised: Curettage and Electrodesiccation (C&E) or shave excision removal or Shave removal (Iif tumor appears to
extend beyond the dermis, surgical or shave excision should generally be performed rather than C&E or shave removal) or Standard excision with
4-mm clinical margins and postoperative margin assessment. Tissue rearrangement (eg, flap reconstruction, extensive undermining) should not be
undertaken until clear margins are identified (second intention healing, linear repair, or skin graft are acceptable) or Radiation therapy (RT) for non-
surgical candidates or Topical therapy Non-surgical modalities for tumors clinically and histologically consistent with superficial BCC (without dermal
extension): Topical 5-fluorouracil (5-FU) (Useful in Certain Circumstances), Topical imiquimod (preferred), Photodynamic therapy (eg, aminolevulinic
acid [ALA], porfimer sodium) (Useful in Certain Circumstances), Cryotherapy.
• Footnotes revised:
Footnote l: In patients with superficial basal cell skin cancer, therapies such as topical imiquimod, topical 5-fluorouracil, photodynamic therapy, or
cryotherapy may be considered, although cCure rates are approximately 10% lower than for surgical treatment modalities. Jansen MHE, et al. J Invest
Dermatol 2018;138:527-533. Drew BA, et al. Dermatol Surg 2017;43:1423-1430.
Footnote o: As per other appropriate use criteria. Task Force/Committee Members, Vidal CI, Armbrect EA, Andrea AA, et al. J Am Acad Dermatol
2019;80:189-207.e11. (Also pages BCC-3A and BCC-4)
Footnote p: PDEMA with permanent section analysis or intraoperative frozen section analysis is an alternative to Mohs. See Principles of PDEMA
Technique (SCC-G) within the NCCN Guidelines for Squamous Cell Skin Cancer. (Also pages BCC-3A and BCC-4)
• New footnotes added:
Footnote i: Shave removal (shaving of epidermal or dermal lesion) is a sharp removal by transverse bowl-shaped slicing to remove epidermal and dermal
lesions (without including fat) and does not require suture closure. Emmett AJ and Bradbent GD. Plast Reconstr Surg. 1987;80:47-54. Abramson AK, et
al. Dermatol Surg. 2013;39:387-392. Wu X, et al. J Am Acad Dermatol. 2015;73:791-798. Dando EE, et al. Dermatol Surg. 2023;49:130-134.
Footnote k: Determination of the appropriateness of RT should be performed by a radiation oncologist. (Also pages BCC-3A and BCC-4)
Footnote m: Afsar FS, et al. Postepy Dermatol Alergol 2015;32:88-93.
Continued

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NCCN Guidelines Version 3.2024 NCCN Guidelines Index

Table of Contents
Basal Cell Skin Cancer Discussion

Updates in Version 1.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2023 include:
BCC-3
• Primary Treatment, options revised: Mohs or other forms of PDEMA (preferred for ≥1 cm, H zone, recurrent, or aggressive histologic subtype) or
Standard excision with wider surgical margins and postoperative margin assessment and second intention healing, linear repair, or skin graft or For
non-surgical candidates: consider multidisciplinary consultation and discussion of definitive RT RT, Systemic therapy if curative RT is not feasible
or For patients in whom surgery may cause significant functional damage, neoadjuvant administration of vismodegib followed by PDEMA may be
considered (category 2B).
• Additional Treatment:
Top column following Positive margins, third bullet revised: Systemic therapy iIf curative If surgery and/or curative RT are not curative.
◊ Link to Advanced BCC (BCC-4) added to far right.
Bottom Positive margins pathway, following "Standard excision," removed: Positive margins, Mohs or other forms of PDEMA, if feasible or Standard
re-excision if PDEMA is not feasible; If residual disease is present, and further surgery is not feasible, consider multidisciplinary consultation to discuss
options: RT, Systemic therapy if curative RT is not feasible.
• Footnotes revised:
Footnote q: For clinically diagnosed non-facial BCCs <6 mm in depth on the head, neck, hands, feet, pretibial, and anogenital area that are clinically
confined to the dermis, C&E or shave excision removal may be considered as an alternative primary treatment option if Mohs, resection with PDEMA,
and standard excision are difficult to perform due to patient comorbidities (eg, thrombocytopenia, immunosuppression, bleeding diathesis, multiple
primary BCCs). See Risk Factors for Recurrence (BCC-B). (Also page BCC-4)
Footnote t: If named nerve involvement is suspected, consider MRI with and without contrast of region of interest to evaluate extent and rule out base
of skull involvement or intracranial extension in head and neck tumors.
• New footnote r added: Aggressive histologic subtype is defined as: BCC with squamous differentiation, infiltrative, micronodular, morpheaform,
sclerodermiform, or sclerosing. van Loo E, et al. Eur J Cancer 2014;50:3011-3020. Fraga SD, et al. Dermatol Surg 2022;48:704-710.
• Footnotes removed:
For locally advanced disease (extensive disease where surgery and/or RT are unlikely to result in a cure or are not feasible), consider multidisciplinary
consultation and treatment with hedgehog pathway inhibitors (HHIs) (vismodegib and sonidegib) or programmed cell death protein 1 (PD-1) inhibitor
(cemiplimab-rwlc) for patients previously treated with an HHI or for whom an HHI is not appropriate. Feasibility of surgery or radiation should be
assessed by a surgeon and radiation oncologist. Principles of Systemic Therapy (BCC-E).
Principles of Systemic Therapy (BCC-E). (Also page BCC-5)
In one study of 55 patients with locally advanced basal cell carcinoma, neoadjuvant administration of vismodegib before planned surgery allowed
for a smaller surgical procedure in 71% of patients, although it carried a high (36.4%) recurrence risk. Bertrand N, et al. E Clinical Medicine
2021;35:100844.

Continued

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Basal Cell Skin Cancer Discussion

Updates in Version 1.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2023 include:
BCC-4
• New page for Advanced BCC.
• New branch points added to left side of the page:
Locally advanced BCC (laBCC) (primary or recurrent extensive disease where surgery and/or RT may not result in a cure or would possibly produce a
significant functional limitation).
◊ Primary Treatment, new options added: Multidisciplinary consultation to consider one or more of the following options: Surgery, Consider
neoadjuvant systemic therapy (BCC-E), Mohs or other forms of PDEMA, Standard excision with vertical histologic sectioning (if Mohs or PDEMA
are not available) or RT or If surgery and/or RT are not feasible then systemic therapy (BCC-E).
Nodal disease.
◊ Primary Treatment, options added: Multidisciplinary consultation to consider one or more of the following options: Surgery or If surgery is not
feasible then RT or systemic therapy (BCC-E), or Clinical trial.
Metastatic disease.
◊ Primary treatment, options added: Multidisciplinary consultation to consider: Systemic therapy (BCC-E) or RT or surgery for limited metastatic
disease or Palliation and best supportive care.
• New footnote v added: Fraga SD, et al. Dermatol Surg 2022;704-710.
BCC-5
• Top header revised: Recurrence or Advanced Disease.
First pathway revised: Local recurrence.
Second pathway revised: Primary or recurrent Advanced disease: Locally advanced, nNodal metastases, Distant metastases.
◊ Options revised: Multidisciplinary consultation to consider one or more of the following options: Surgery or If surgery is not feasible then RT or
systemic therapy, Hedgehog pathway inhibitor (HHI), Vismodegib, Sonidegib (category 2B), Programmed cell death protein 1 (PD-1) inhibitor
(cemiplimab-rwlc), Clinical trial Follow Primary Treatment pathways for Advanced BCC (BCC-4).
Pathway removed: Distant metastases.
◊ Options removed: Multidisciplinary consultation to consider: Systemic therapy, HHI, Vismodegib, PD-1 inhibitor (cemiplimab-rwlc) or RT or surgery
for limited metastatic disease or Palliation and best supportive care.
• Footnotes revised:
Footnote x: Follow-up with a dermatologist is strongly recommended if any of the following criteria are met: past or imminent solid organ, marrow, or
stem hematopoietic cell transplant; one or more cutaneous melanomas in the past 5 years; or four or more non-melanoma skin cancers in the past 5
years.
Footnote y: Imaging modality and targeted area should be at the discretion of the treating team based on the suspected extent of disease (ie, local,
regional, metastatic). Histologic confirmation is often sufficient to diagnose local recurrence, but MRI can be considered to assess extent of local
disease. . .
• Footnotes removed:
Principles of Radiation Therapy (BCC-D).
Cemiplimab-rwlc is recommended for patients with locally advanced or metastatic basal cell carcinoma (mBCC) previously treated with an HHI or for
whom an HHI is not appropriate.
Under highly selective circumstances, in the context of multidisciplinary consultation, resection of limited metastases can be considered.
Continued

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NCCN Guidelines Version 3.2024 NCCN Guidelines Index

Table of Contents
Basal Cell Skin Cancer Discussion

Updates in Version 1.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2023 include:
BCC-B
• Location/size, second line under High Risk revised: Head, neck, hands, feet, pretibial, and anogenital area (any size).
BCC-C
• Third bullet revised: In certain patients at high risk for multiple primary tumors (eg, basal cell nevus syndrome [Gorlin syndrome], xeroderma
pigmentosum, history of RT), increased surveillance and consideration of prophylactic measures may be indicated. Consider rReferring patients with
suspected basal cell nevus syndrome (Gorlin syndrome) or xeroderma pigmentosum for genetic evaluation.
• Fourth bullet revised: In patients with superficial basal cell skin cancer, therapies such as topical imiquimod, topical 5-fluorouracil 5-FU, photodynamic
therapy (eg, aminolevulinic acid [ALA], porfimer sodium), or cryotherapy may be considered, even though the cure rates may be lower than with
surgical treatment modalities.
• New footnote a added: Cure rates are approximately 10% lower than for surgical treatment modalities. Jansen MHE, Mosterd K, Arits AHMM, et al.
Five-year results of a randomized controlled trial comparing effectiveness of photodynamic therapy, topical imiquimod, and topical 5-fluorouracil in
patients with superficial basal cell carcinoma. J Invest Dermatol 2018;138:527-533. Drew BA, Karia PS, Mora AN, et al. Treatment patterns, outcomes,
and patient satisfaction of primary epidermally limited nonmelanoma skin cancer. Dermatol Surg 2017;43:1423-1430.
BCC-D
• General Principles, second bullet revised: RT is contraindicated for genetic conditions predisposing to skin cancer (eg, basal cell nevus syndrome
[Gorlin syndrome]) and relatively contraindicated for patients with connective tissue diseases (eg, scleroderma).
• Regional Disease, Lymph node regions, without lymph node dissection, option removed: Clinically negative, at risk.
RT dosing, option removed: 50 Gy over 5 to 7 weeks.
BCC-E 1 of 2
• Header revised: Locally Advanced (laBCC), Nodal or Distant Metastatic Basal Cell Carcinoma (mBCC).
First bullet revised: Systemic therapy may be considered for laBCC and mBCC. Locally advanced disease is defined by those that have primary or
recurrent extensive disease where surgery and/or RT are unlikely to result in a cure may not result in a cure or would possibly produce a significant
functional limitation.
Fourth bullet revised: Systemic therapy options include: Hedgehog pathway inhibitors (HHIs).
◊ Sub-bullets removed:
– Hedgehog pathway inhibitors (HHIs) (ie, vismodegib, sonidegib).
– Cemiplimab-rwlc is recommended for patients with laBCC or mBCC previously treated with an HHI or for whom an HHI is not appropriate.
◊ Second tertiary-bullet moved out to be a sub-bullet and revised: HHIs may be considered for diffuse BCC formation (eg, basal cell nevus syndrome
[Gorlin syndrome] or other genetic forms of multiple BCC). HHIs are not FDA approved for basal cell nevus syndrome (Gorlin syndrome); however,
they may be used off-label and are effective based on a randomized controlled trial.
◊ Tertiary bullet removed: Current FDA-approved HHIs include vismodegib and sonidegib.1 Vismodegib is FDA approved for the treatment of adults
with mBCC or laBCC that has recurred following surgery, or those who are not candidates for surgery or RT. Sonidegib1 is FDA approved for the
treatment of adults with laBCC that has recurred following surgery or RT, or those who are not candidates for surgery or RT. Sonidegib is not FDA
approved for the treatment of adults with mBCC.

Continued

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NCCN Guidelines Version 3.2024 NCCN Guidelines Index

Table of Contents
Basal Cell Skin Cancer Discussion

Updates in Version 1.2024 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2023 include:
BCC-E 1 of 2 (continued)
• New preference stratification table added with information from BCC-3, BCC-3A, BCC-5 and old BCC-E:
Locally Advanced Disease - Neoadjuvant.
◊ Other Recommended Regimens, Vismodegib (category 2B).
◊ Useful in Certain Circumstances, new regimen added: Cemiplimab-rwlc (category 2B).
Locally Advanced Disease:
◊ Other Recommended Regimens:
– Sonidegib
– Vismodegib
◊ Useful in Certain Circumstances, Cemiplimab-rwlc.
Nodal Disease:
◊ Other Recommended Regimens:
– Vismodegib
– Sonidegib (category 2B)
◊ Useful in Certain Circumstances, Cemiplimab-rwlc.
Metastatic Disease
◊ Other Recommended Regimens, Vismodegib.
◊ Useful in Certain Circumstances, Cemiplimab-rwlc.
• New footnotes added:
Footnote a: In one study of 55 patients with laBCC, neoadjuvant administration of vismodegib before planned surgery allowed for a smaller surgical
procedure in 71% of patients, although it carried a high (36.4%) recurrence risk.
Footnote b: Cemiplimab-rwlc is FDA approved for patients with laBCC or mBCC previously treated with an HHI or for whom an HHI is not appropriate.
Footnote c: A multinational single-arm phase 2 trial, consisting of 84 patients with laBCC (local invasion precluding complete resection or in locations
for which surgery may result in severe disfigurement or dysfunction) whose disease had progressed on or was intolerant to prior HHI therapy, was
conducted. Thirty-one percent had an objective response, including 6% with a complete response. See Discussion.
BCC-E 2 of 2
• New references added:
Bertrand N, Guerreschi P, Basset-Seguin N, et al. Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma: First results of a
multicenter, open-label, phase 2 trial (VISMONEO study): Neoadjuvant Vismodegib in Locally Advanced Basal Cell Carcinoma. EClinicalMedicine
2021;35:100844.
Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med 2012;366:2171-2179.
Dreno B, Basset-Seguin N, Caro I, Yue H, Schadendorf D. Clinical benefit assessment of vismodegib therapy in patients with advanced basal cell
carcinoma. Oncologist 2014;19:790-796.
Stratigos AJ, Sekulic A, Peris K, et al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-
centre, single-arm, phase 2 trial. Lancet Oncol 2021;22:848-857.
BCC-F
• Second bullet revised: In certain patients at high risk for multiple primary tumors (eg, basal cell nevus syndrome [Gorlin syndrome], xeroderma
pigmentosum, history of RT), increased surveillance and consideration of prophylactic measures may be indicated. . .

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Basal Cell Skin Cancer Discussion

CLINICAL PRELIMINARY DIAGNOSIS ADDITIONAL RISK STATUSc STAGING PRIMARY

PRESENTATION WORKUP WORKUP TREATMENT

Low risk BCC-2

Lesion • H&P Consider imaging

suspicious • Biopsya,b Basal cell Complete if clinical exam
for skin • Shave removal carcinoma skin High riskb,d,e insufficient for BCC-3
cancer if applicable (BCC) examination determining disease
extentg
Locally Consider imaging to
advanced determine disease
disease extent

Imaging studies of BCC-4

Initial presentation
areas of interest
of regional or
as indicated for
distant metastatic
suspicion of
diseasef
extensive diseased,g

a Principles of Pathology (BCC-A).

b Risk Factors for Recurrence (BCC-B).
c Morgan FC, et al. J Am Acad Dermatol 2021;85:582-587.
d Extensive disease includes deep involvement such as bone, named nerves, and deep soft tissue. If disease of named nerve(s) is suspected, MRI with and without
contrast is preferred. If bone disease is suspected, CT with contrast is preferred unless contraindicated.
e Any high-risk factor places the patient in the high-risk category.
f For rare cases that present with regional or distant metastatic disease at diagnosis, treat per nodal or metastatic pathways on BCC-4.
g Imaging modality and targeted area should be at the discretion of the treating team based on the suspected extent of disease (ie, local, regional, metastatic). Histologic
confirmation is sufficient to diagnose local recurrence, but MRI with and without contrast can be considered to assess extent of local disease. For nodal or distant
metastasis, histologic analysis and/or CT imaging can be used for confirmation and to gauge extent of disease.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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PRIMARY TREATMENTh ADDITIONAL TREATMENT

Curettage and electrodesiccation (C&E)
or
Shave removali (if tumor appears to extend beyond
the dermis, surgical excision should generally be Mohsn,o or other forms of
performed rather than C&E or shave removali) peripheral and deep en face
or Positive margin assessment (PDEMA)p
margins or
Standard excision with 4-mm clinical margins and
Re-excision if clinically feasible
postoperative margin assessment. Tissue rearrangement
or
(eg, flap reconstruction, extensive undermining) should not
RTj,k for non-surgical candidatesh
be undertaken until clear margins are identified (second
Low-risk intention healing, linear repair, or skin graft are acceptable) Follow-up
BCCa,b Negative (BCC-5)
or margins
Radiation therapy (RT)j,k for non-surgical candidatesh
or
Non-surgical modalities for tumors clinically and histologically consistent
with superficial BCC (without dermal extension):
• Topical imiquimodl (preferred)
• Topical 5-fluorouracil (5-FU)l (Useful in Certain Circumstances)
• Photodynamic therapyl (eg, topical aminolevulinic acid [ALA], porfimer
sodium [category 2B]) (Useful in Certain Circumstances)
• Cryotherapym

k Determination of the appropriateness of RT should be performed by a radiation oncologist.

a Principles of Pathology (BCC-A). l Cure rates are approximately 10% lower than for surgical treatment modalities. Jansen MHE, et
b Risk Factors for Recurrence (BCC-B). al. J Invest Dermatol 2018;138:527-533. Drew BA, et al. Dermatol Surg 2017;43:1423-1430.
h Principles of Treatment (BCC-C). m Afsar FS, et al. Postepy Dermatol Alergol 2015;32:88-93.
i Shave removal (shaving of epidermal or dermal lesion) is a sharp removal n Mohs surgery should be performed by dermatologic surgeons who have specialized training and
by transverse bowl-shaped slicing to remove epidermal and dermal experience in this procedure.
lesions (without including fat) and does not require suture closure. Emmett o As per other appropriate use criteria. Task Force/Committee Members, Vidal CI, et al. J Am Acad
AJ and Bradbent GD. Plast Reconstr Surg. 1987;80:47-54. Abramson AK, Dermatol 2019;80:189-207.
et al. Dermatol Surg. 2013;39:387-392. Wu X, et al. J Am Acad Dermatol. p PDEMA with permanent section analysis or intraoperative frozen section analysis is an
2015;73:791-798. Dando EE, et al. Dermatol Surg. 2023;49:130-134. alternative to Mohs. See Principles of PDEMA Technique (SCC-G) within the NCCN Guidelines
j Principles of Radiation Therapy (BCC-D). for Squamous Cell Skin Cancer.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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PRIMARY TREATMENTh ADDITIONAL TREATMENT

Multidisciplinary consultation
Mohsn,o or other forms of to discuss options:
PDEMA (preferred for BCCs • Re-resect,
that are either recurrent, ≥1 Positive if feasible Follow-up
cm in H zone, or ≥1 cm with margins or (BCC-5)
an aggressive histologic • RTj,k
subtype)p,q,r or
Advanced BCC
or If surgery and/or RTk are not curative
(BCC-4)
Standard excision with
High-risk wider surgical marginss
BCCa,b,e and postoperative margin Negative If extensive perineural or large-nerve
assessment and second margins involvement,b,t consider adjuvant RT h,j,u
intention healing, linear
repair, or skin graft
or Follow-up
(BCC-5)
For non-surgical candidatesh
consider multidisciplinary
consultation and discussion
of definitive RTj,k

a Principles of Pathology (BCC-A). p PDEMA with

permanent section analysis or intraoperative frozen section analysis is an alternative to Mohs. See Principles of
b Risk Factors for Recurrence (BCC-B). PDEMA Technique (SCC-G) within the NCCN Guidelines for Squamous Cell Skin Cancer.
q For clinically diagnosed non-facial BCCs <6 mm in depth on the head, neck, hands, feet, pretibial, and anogenital area
e Any high-risk factor places the patient in
the high-risk category. that are clinically confined to the dermis, C&E or shave removal may be considered as an alternative primary treatment
h Principles of Treatment (BCC-C). option if Mohs, resection with PDEMA, and standard excision are difficult to perform due to patient comorbidities (eg,
j Principles of Radiation Therapy (BCC-D). thrombocytopenia, immunosuppression, bleeding diathesis, multiple primary BCCs). See Risk Factors for Recurrence
k Determination of the appropriateness of (BCC-B).
RT should be performed by a radiation r Aggressive histologic subtype is defined as: BCC with squamous differentiation, infiltrative, micronodular, morpheaform,
oncologist. sclerodermiform, or sclerosing. van Loo E, et al. Eur J Cancer 2014;50:3011-3020. Fraga SD, et al. Dermatol Surg
n Mohs surgery should be performed 2022;48:704-710.
s Due to the wide variability of clinical characteristics that may define a high-risk tumor, it is not feasible to recommend a
by dermatologic surgeons who have
specialized training and experience in defined margin for standard excision of high-risk BCC. Keen awareness of the subclinical extension of BCC is advised when
this procedure. selecting a treatment modality without complete margin assessment for a high-risk tumor. These margins may need to be
o As per other appropriate use criteria. modified based on tumor- or patient-specific factors.
Task Force/Committee Members, t If named nerve involvement is suspected, consider MRI with and without contrast of region of interest to evaluate extent and
Vidal CI, et al. J Am Acad Dermatol rule out base of skull involvement or intracranial extension in head and neck tumors.
u There are conflicting data about the value of adjuvant RT following margin-negative surgical excision, particularly after Mohs.
2019;80:189-207.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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PRIMARY TREATMENTh
Multidisciplinary consultation to consider one or more of the following options:
• Surgery
Locally advanced BCC (laBCC) Consider neoadjuvant systemic therapy (BCC-E)
(primary or recurrent extensive Mohsn,o or other forms of PDEMAp,q,v
disease where surgery and/or RT Standard excision with vertical histologic sectioning (if Mohs or PDEMA are
may not result in a cure or would not available)
possibly produce a significant or
functional limitation) • RTj,k
or
• If surgery and/or RTj,k are not feasible then systemic therapy (BCC-E)

Multidisciplinary consultation to consider one or more of the following options: Follow-up

• Surgery (BCC-5)
Advanced or
BCCa,b,e Nodal disease • If surgery is not feasible then RTj,k or systemic therapy (BCC-E)
or
• Clinical trial

Multidisciplinary consultation to consider:

• Systemic therapy (BCC-E)
or
Metastatic disease
• RTj,k or surgery for limited metastatic diseasew
or
• Palliation and best supportive care

p PDEMA with permanent section analysis or intraoperative frozen section analysis is an

a Principles of Pathology (BCC-A). alternative to Mohs. See Principles of PDEMA Technique (SCC-G) within the NCCN Guidelines
b Risk Factors for Recurrence (BCC-B). for Squamous Cell Skin Cancer.
e Any high-risk factor places the patient in the high-risk category. q For clinically diagnosed non-facial BCCs <6 mm in depth on the head, neck, hands, feet,
h Principles of Treatment (BCC-C). pretibial, and anogenital area that are clinically confined to the dermis, C&E or shave
j Principles of Radiation Therapy (BCC-D). removal may be considered as an alternative primary treatment option if Mohs, resection
k Determination of the appropriateness of RT should be performed with PDEMA, and standard excision are difficult to perform due to patient comorbidities (eg,
by a radiation oncologist. thrombocytopenia, immunosuppression, bleeding diathesis, multiple primary BCCs). See Risk
n Mohs surgery should be performed by dermatologic surgeons Factors for Recurrence (BCC-B).
who have specialized training and experience in this procedure. v Fraga SD, et al. Dermatol Surg 2022;48:704-710.
o As per other appropriate use criteria. Task Force/Committee w Under highly selective circumstances, in the context of multidisciplinary consultation, resection
Members, Vidal CI, et al. J Am Acad Dermatol 2019;80:189-207. of limited metastases can be considered.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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FOLLOW-UP RECURRENCE

• H&P
Including complete skin Local Follow Primary Treatment pathway
exam every 6–12 mo for for High-risk disease (BCC-3)
the first 5 years, and then
at least annually for lifex
• Consider imaging if clinical
exam is insufficient for
following the diseasey Advanced disease:
• Patient education: • Locally advanced Follow Primary Treatment pathways
Sun protection • Nodal metastases for Advanced BCC (BCC-4)
Self-examination • Distant metastases

x Follow-up with a dermatologist is strongly recommended if any of the following criteria are met: past or imminent solid organ, marrow, or hematopoietic cell transplant; one
or more cutaneous melanomas in the past 5 years; or four or more non-melanoma skin cancers in the past 5 years.
y Imaging modality and targeted area should be at the discretion of the treating team based on the suspected extent of disease (ie, local, regional, metastatic). Histologic
confirmation is sufficient to diagnose local recurrence, but MRI can be considered to assess extent of local disease. For nodal or distant metastasis, histologic analysis
and/or CT imaging can be used for confirmation and to gauge extent of disease.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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PRINCIPLES OF PATHOLOGY
Principles of Biopsy Reporting:
• The intent of a biopsy is for diagnosis, not to assess the margin status.
• Pathologic evaluation of skin biopsies is ideally performed by a dermatologist, pathologist, dermatopathologist, or Mohs surgeon who is
experienced in interpreting cutaneous neoplasms.
• Clinical information to be submitted on biopsy requisition includes patient age and gender, clinical diameter of lesion, anatomic location,
and prior treatment of lesion. Additional helpful features to include are immunosuppression and history of RT.
• Pathologic report should include histologic subtypea and presence and extent of any features that would increase the risk for local
recurrence, including invasion of tumor beyond reticular dermis and presence of perineural invasion.1

Principles of Excision Reporting:

• The intent of excision is to clear the tumor and thus margin status needs to be reported.
• Saucerization specimens intended for definitive surgical therapy should be labeled as such, as they can be histopathologically difficult to
distinguish from shave biopsies but must be evaluated for margin status.
• Clinical information to be submitted on excision requisition includes patient age and gender, anatomic location, clinical diameter of lesion,
and additional clinical information listed above under Principles of Biopsy Reporting.
• Minimal reporting elements to be reported for all surgical specimens include histologic subtype of BCC,a invasion of tumor beyond deep
reticular dermis, presence of perineural invasion (if involving nerve below dermis or if largest nerve involved is ≥0.1 mm in caliber) and
angiolymphatic invasion, and peripheral and deep margin status.
• For Mohs excisions, reporting of these elements is also encouraged. Since depth of invasion (in mm) may not be ascertained on
tangentially cut Mohs specimens, anatomic level of invasion should be reported. Frozen or permanent section analysis of the clinical
tumor specimen may be undertaken if needed for complete reporting of features associated with poor prognosis.2

Footnotes
a Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus;
high-risk subtypes include basosquamous, infiltrative, sclerosing/morpheaform, micronodular, and BCC with carcinosarcomatous differentiation.
References
1 Work Group; Invited Reviewers, Kim JYS, et al. Guidelines of care for the management of basal cell carcinoma. J Am Acad Dermatol 2018;78:540-559.
2 Morgan FC, Ruiz ES, Karia PS, et al. Brigham and Women's Hospital tumor classification system for basal cell carcinoma identifies patients with risk of metastasis and
death. J Am Acad Dermatol 2021;85:582-587.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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STRATIFICATION TO DETERMINE TREATMENT OPTIONS FOR LOCAL BCC BASED ON RISK FACTORS
FOR RECURRENCEa

Risk Group Low Risk High Risk

Treatment options BCC-2 BCC-3

H&P
Trunk, extremities ≥2 cm
Location/size Trunk, extremities <2 cm Head, neck, hands, feet, pretibial, and anogenital area (any size)c
Borders Well-defined Poorly defined
Primary vs. recurrent Primary Recurrent
Immunosuppression (-) (+)
Site of prior RT (-) (+)
Pathology (BCC-A)
Subtype Nodular, superficialb Aggressive growth patternd
Perineural involvement (-) (+)

a Any high-risk factor places the patient in the high-risk category.

b Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus.
c This area constitutes high risk based on location, independent of size. Narrow excision margins due to anatomic and functional constraints are associated with
increased recurrence rates with standard histologic processing. Complete margin assessment such as with Mohs or PDEMA is recommended for optimal tumor
clearance and maximal tissue conservation. For tumors <6 mm in size, without other high-risk features, other treatment modalities may be considered if at least 4-mm
clinically tumor-free margins can be obtained without significant anatomic or functional distortions.
d Having basosquamous, infiltrative, sclerosing/morpheaform, micronodular, and BCC with carcinosarcomatous differentiation features in any portion of the tumor. In
some cases, basosquamous tumors may be prognostically similar to squamous cell carcinoma (SCC); clinicopathologic correlation is recommended in these cases to
further consider prognostic implication.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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PRINCIPLES OF TREATMENT
• The primary treatment goals of BCC is the complete removal of the tumor and the maximal preservation of function and cosmesis.
All treatment decisions should be customized to account for the particular factors present in the individual case and for the patient’s
preference.

• Surgical approaches often offer the most effective and efficient means for accomplishing cure, but considerations of function, cosmesis,
and patient preference may lead to choosing RT/topical therapy/systemic therapy as primary treatment in order to achieve optimal overall
results.

• In certain patients at high risk for multiple primary tumors (eg, basal cell nevus syndrome [Gorlin syndrome], xeroderma pigmentosum,
history of RT), increased surveillance and consideration of prophylactic measures may be indicated. Refer patients with suspected basal cell
nevus syndrome or xeroderma pigmentosum for genetic evaluation.

• In patients with superficial basal cell skin cancer, non-surgical modalities may be considered. (See BCC-2)

• When Mohsb with margin assessment is being performed and the preoperative biopsy is considered insufficient for providing all the staging
information required to properly treat the tumor, submission of the central specimen for vertical paraffin-embedded permanent sections or
documentation of staging parameters in Mohs report is recommended.

• Use of nicotinamide may be effective in reducing the development of basal cell skin cancers.1,2

Footnotes
a Cure rates are approximately 10% lower than for surgical treatment modalities. Jansen MHE, Mosterd K, Arits AHMM, et al. Five-year results of a randomized
controlled trial comparing effectiveness of photodynamic therapy, topical imiquimod, and topical 5-fluorouracil in patients with superficial basal cell carcinoma. J Invest
Dermatol 2018;138:527-533. Drew BA, Karia PS, Mora AN, et al. Treatment patterns, outcomes, and patient satisfaction of primary epidermally limited nonmelanoma
skin cancer. Dermatol Surg 2017;43:1423-1430.
b Mohs surgery should be performed by dermatologic surgeons who have specialized training and experience in this procedure.
References
1 Chen AC, Martin AJ, Dalziell RA, et al. A phase II randomized controlled trial of nicotinamide for skin cancer chemoprevention in renal transplant recipients. Br J
Dermatol 2016;175:1073-1075.
2 Chen AC, Martin AJ, Choy B, et al. A phase 3 randomized trial of nicotinamide for skin-cancer chemoprevention. N Engl J Med 2015;373:1618-1626.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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PRINCIPLES OF RADIATION THERAPY

General Principlesa
• Protracted fractionation is associated with improved cosmetic results and should be utilized for poorly vascularized or cartilaginous areas.
• RT is contraindicated for genetic conditions predisposing to skin cancer (eg, basal cell nevus syndrome and relatively contraindicated for patients with
connective tissue diseases (eg, scleroderma).
• Given higher complication rates, re-irradiation should not be routinely utilized for recurrent disease within a prior radiation field.
• Isotope-based brachytherapy can be an effective treatment for certain sites of disease, particularly on the head and neck.
• There are insufficient long-term efficacy and safety data to support the routine use of electronic surface brachytherapy.

General Treatment Information

• Radiation treatments should be given by a practicing radiation oncologist with radiation physics support to meet established quality assurance and
dosimetric constraints.

Primary Tumor RT Dosing

Definitive RT BED10 of 70–93 Gy for conventional fractionation
BED10 of 56–88 Gy for hypofractionation
Postoperative adjuvant RT BED10 of 60–79 Gy for conventional fractionation
BED10 of 56–70 Gy for hypofractionation
Regional Disease
• Lymph node regions, after lymph node dissection
Negative margins, no extranodal extension (ENE) 50–60 Gy over 5 to 6 weeks
Positive margins or ENE 60–66 Gy over 6 to 7 weeks
• Lymph node regions, without lymph node dissection
Clinically positive 60–70 Gy over 6 to 7 weeks
• Clinically at-risk nerves 50–60 Gy over 5 to 6 weeks

• BED = Biologically effective dose

• Conventionally fractionated radiotherapy consists of five daily treatments per week.
• Hypofractionated radiotherapy consists of daily treatments or two to four treatments per week. Fraction sizes larger than 6 Gy are not routinely
recommended outside of the palliative setting.

a ASTRO Guideline on Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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PRINCIPLES OF SYSTEMIC THERAPY

Locally Advanced (laBCC), Nodal or Distant Metastatic Basal Cell Carcinoma (mBCC)
• Systemic therapy may be considered for laBCC. Locally advanced disease is defined by those that have primary or recurrent extensive disease where
surgery and/or RT may not result in a cure or would possibly produce a significant functional limitation.
• Systemic therapy may be considered for cases of nodal or distant metastatic disease, especially if surgery and RT are not feasible.
• Multidisciplinary consultation may be required to determine the best treatment approach and deem the tumor not amendable to surgery or RT.
• Hedgehog pathway inhibitors (HHIs)
Due to frequency of intolerable side effects associated with HHIs, drug holidays or other alternatives to daily dosing can be used to reduce side effects
to improve adherence to therapy and quality of life.
HHIs may be considered for diffuse BCC formation (eg, basal cell nevus syndrome or other genetic forms of multiple BCC). HHIs are not FDA approved
for basal cell nevus syndrome; however, they may be used off-label and are effective based on a randomized controlled trial.1
• The role of adjuvant systemic therapy for resected BCC is unclear and thus, adjuvant systemic therapy is best performed in a clinical trial setting.

Preferred Regimens Other Recommended Regimens Useful in Certain Circumstances

Locally Advanced Disease - • None • Vismodegiba,2 (category 2B) • Cemiplimab-rwlcb (category 2B)
Neoadjuvant
Locally Advanced Disease • None • Sonidegib3 • Cemiplimab-rwlcb,c,6
• Vismodegib4,5
Nodal Disease • None • Vismodegib • Cemiplimab-rwlcb
• Sonidegib3 (category 2B)
Metastatic Disease • None • Vismodegib4,5 • Cemiplimab-rwlcb,6

a In one study of 55 patients with laBCC, neoadjuvant administration of vismodegib before planned surgery allowed for a smaller surgical procedure in 71% of patients,
although it carried a high (36.4%) recurrence risk.2
b Cemiplimab-rwlc is FDA approved for patients with laBCC or mBCC previously treated with an HHI or for whom an HHI is not appropriate.
c A multinational single-arm phase 2 trial, consisting of 84 patients with locally advanced BCC (local invasion precluding complete resection or in locations for which
surgery may result in severe disfigurement or dysfunction) whose disease had progressed on or was intolerant to prior HHI therapy, was conducted. Thirty-one percent
had an objective response, including 6% with a complete response. See Discussion.6
References on
Note: All recommendations are category 2A unless otherwise indicated. BCC-E (2 of 2)
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REFERENCES
1 Tang JY, Ally MS, Chanana AM, et al. 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;17:1720-1731.
2 Bertrand N, Guerreschi P, Basset-Seguin N, et al. Vismodegib in neoadjuvant treatment of locally advanced basal cell carcinoma: First results of a multicenter, open-
label, phase 2 trial (VISMONEO study): Neoadjuvant Vismodegib in Locally Advanced Basal Cell Carcinoma. EClinicalMedicine 2021;35:100844.
3 Dummer R, Guminksi A, Gutzmer R, et al. Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II
randomized, double-blind BOLT study. Br J Dermatol 2020;182:1369-1378.
4 Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med 2012;366:2171-2179.
5 Dreno B, Basset-Seguin N, Caro I, Yue H, Schadendorf D. Clinical benefit assessment of vismodegib therapy in patients with advanced basal cell carcinoma.
Oncologist. 2014;19:790-796.
6 Stratigos AJ, Sekulic A, Peris K, et al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm,
phase 2 trial. Lancet Oncol. 2021;22:848-857.

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.
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PRINCIPLES OF CANCER RISK ASSESSMENT AND COUNSELING

• The decision to offer genetic testing involves three related stages:
1) Pre-test counseling prior to ordering testing;
2) Consideration of the most appropriate testing strategy; and
3) Testing result disclosure and post-test counseling.
• In certain patients at high risk for multiple primary tumors (eg, basal cell nevus syndrome, xeroderma pigmentosum, history of RT),
increased surveillance and consideration of prophylactic measures may be indicated. Patients with these conditions should be referred to a
cancer center with particular expertise in BCC prevention and prophylaxis.
• It is recommended that a genetic counselor, medical geneticist, endocrinologist, oncologist, surgeon, oncology nurse, or other health
professional with expertise and experience in cancer genetics be involved at each stage whenever possible. Clinicians without direct referral
access to the appropriate expertise should be aware of the telehealth genetic counseling options available. These resources can be found
through the National Society of Genetic Counselors (NSGC) “Find a Genetic Counselor” tool (www.nsgc.org).

See the NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic for the following:
• Principles of Cancer Risk Assessment and Counseling (EVAL-A)
• Pedigree: First-, Second-, and Third-Degree Relatives of Proband (EVAL-B)
• General Testing Criteria (CRIT-1)

Note: All recommendations are category 2A unless otherwise indicated.

Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged.

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Table of Contents
Basal Cell Skin Cancer Discussion

ABBREVIATIONS

ALA aminolevulinic acid

BCC basal cell carcinoma

BED biologically effective dose

C&E curettage and electrodesiccation

ENE extranodal extension

H&P history and physical

HHI hedgehog pathway inhibitors

laBCC locally advanced basal cell carcinoma

mBCC metastatic basal cell carcinoma

PDEMA peripheral and deep en face margin

assessment

SCC squamous cell carcinoma

ABBR-1
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NCCN Categories of Evidence and Consensus

Category 1 Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2A Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2B Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.
Category 3 Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.
All recommendations are category 2A unless otherwise indicated.

NCCN Categories of Preference

Interventions that are based on superior efficacy, safety, and evidence; and, when appropriate,
Preferred intervention affordability.
Other recommended Other interventions that may be somewhat less efficacious, more toxic, or based on less mature data;
intervention or significantly less affordable for similar outcomes.
Useful in certain
Other interventions that may be used for selected patient populations (defined with recommendation).
circumstances
All recommendations are considered appropriate.

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Discussion This discussion corresponds to the NCCN Guidelines for Basal Cell Skin Cancer. Last updated: September 15, 2023.

Table of Contents

Overview .................................................................................... MS-2

Guidelines Update Methodology............................................... MS-2
Literature Search Criteria and Guidelines Update Methodology
................................................................................................... MS-2
Sensitive/Inclusive Language ................................................... MS-2
Genetics ..................................................................................... MS-3
Clinical Presentation and Workup ............................................ MS-3
Risk Stratification of Local BCC Based on Risk Factors for
Recurrence ................................................................................ MS-3
History & Physical Examination ................................................ MS-4
Pathology ................................................................................. MS-5
Treatment Modalities for BCC ................................................... MS-6
Curettage and Electrodesiccation ............................................. MS-6
Shave Removal ........................................................................ MS-7
Standard Excision with Postoperative Margin Assessment........ MS-7
Mohs Micrographic Surgery and Peripheral and Deep En Face
Margin Assessment .................................................................. MS-7
Radiation Therapy .................................................................... MS-9
Superficial Therapies................................................................ MS-9
Systemic Therapy .................................................................. MS-11
Follow-up ................................................................................. MS-13
References ............................................................................... MS-15

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Overview Literature Search Criteria and Guidelines Update

Basal cell carcinoma (BCC) is the most common cancer in the United
Methodology
States. It is estimated that BCCs occur in 2 million Americans annually, Prior to the update of this version of the NCCN Clinical Practice
exceeding the incidence of all other cancers combined.1-3 BCCs are at Guidelines in Oncology (NCCN Guidelines®) for Basal Cell Skin Cancer,
least two times more common than squamous cell carcinomas (SCCs), an electronic search of the PubMed database was performed to obtain
the second most common type of skin cancer.1-6 Furthermore, the key literature using the following search term: basal cell skin carcinoma.
incidence of this common malignancy is rising rapidly.1,3,6,7 Compared The PubMed database was chosen as it remains the most widely used
with SCC, BCCs are much less likely to metastasize, with a metastatic resource for medical literature and indexes peer-reviewed biomedical
rate of <0.1%, and thus generally have a good prognosis.8-10 Although literature.28
rarely metastatic, BCC can produce substantial local destruction along
The search results were narrowed by selecting studies in humans
with disfigurement and may involve extensive areas of soft tissue,
published in English. Results were confined to the following article
cartilage, and bone.
types: Clinical Trial; Guideline; Meta-Analysis; Practice Guideline;
A number of risk factors are associated with the development of BCC. Randomized Controlled Trial; Systematic Reviews; and Validation
The most recognized environmental carcinogen is sunlight. Evidence Studies.
reveals that the relationship between sun exposure and BCC is
The data from key PubMed articles as well as articles from additional
complex, and depends on the timing, pattern, and amount of ultraviolet
sources deemed as relevant to these guidelines as discussed by the
(UV) radiation.11-15 Fair skin, red or blond hair, and light eye color are
panel during the Guidelines update have been included in this version
associated with BCC as independent risk factors due to greater
of the Discussion section. Recommendations for which high-level
susceptibility to UV damage.13,15-22 BCC risk is increased by both UV-A
evidence is lacking are based on the panel’s review of lower-level
and -B radiation as well as by ionizing radiation. Radiation therapy (RT)
evidence and expert opinion.
for other conditions, especially at a young age, is also associated with
an increased risk for developing BCC.23-27 Most BCC tumors develop on
Sensitive/Inclusive Language
skin sites exposed to radiation—either from the sun or from therapy.23-25
NCCN Guidelines strive to use language that advances the goals of
Guidelines Update Methodology equity, inclusion, and representation.29 NCCN Guidelines endeavor to
use language that is person-first; not stigmatizing; anti-racist, anti-
The complete details of the Development and Update of the NCCN
classist, anti-misogynist, anti-ageist, anti-ableist, and anti-weight biased;
Guidelines are available at www.NCCN.org.
and inclusive of individuals of all sexual orientations and gender
identities. NCCN Guidelines incorporate non-gendered language,
instead focusing on organ-specific recommendations. This language is

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both more accurate and more inclusive and can help fully address the Clinical Presentation and Workup
needs of individuals of all sexual orientations and gender identities. On clinical presentation of the patient with lesion suspicious of skin
NCCN Guidelines will continue to use the terms men, women, female, cancer, workup for BCC begins with a history and physical examination,
and male when citing statistics, recommendations, or data from biopsy, and if applicable a shave removal. A skin biopsy is then
organizations or sources that do not use inclusive terms. Most studies performed on any suspicious lesion. The biopsy should include deep
do not report how sex and gender data are collected and use these reticular dermis. This procedure is preferred because an infiltrative
terms interchangeably or inconsistently. If sources do not differentiate histology may sometimes be present only at the deeper, advancing
gender from sex assigned at birth or organs present, the information is margins of a tumor, and superficial biopsies will frequently miss this
presumed to predominantly represent cisgender individuals. NCCN component.52,53 After BCC diagnosis, a full skin examination is
encourages researchers to collect more specific data in future studies recommended, because individuals with skin cancer often have
and organizations to use more inclusive and accurate language in their additional, concurrent precancers or cancers located at other, usually
future analyses. sun-exposed skin sites. These individuals are also at increased risk of
developing cutaneous melanoma.54
Genetics
Extensive research has led to advances in the understanding of the Risk Stratification of Local BCC Based on Risk Factors
genetics of BCC. The sonic hedgehog signaling pathway has emerged for Recurrence
as playing a pivotal role in the pathogenesis of BCC, and mutations in a After the complete skin examination, a risk assessment should be
number of molecules in this pathway have been implicated in the performed to determine the treatment plan.55 The NCCN Panel
development of the disease.30-32 Mutations in the PTCH1 (patched 1) examined risk factors for BCC associated with recurrence (see Risk
gene on chromosome 9q, which codes for the sonic hedgehog receptor, Factors for Recurrence in the algorithm). Any high-risk factor places the
are the underlying cause of nevoid BCC syndrome, and are present in skin lesion in the high-risk category and imaging should be considered if
approximately 30% to 90% of sporadic BCCs.33-41 Specific UV-induced a clinical exam is insufficient to determine disease extent. Skin lesions
mutations in the tumor suppressor gene p53 appear to be a common in populations placed at increased risk may be difficult to assess
event in BCC development.35,38,41,42 Certain genetic syndromes greatly clinically; therefore, a low threshold for performing skin biopsies in these
predispose affected individuals to skin cancer formation, including BCC, patients is necessary. Patients with locally advanced disease, which is
such as albinism43,44 and xeroderma pigmentosum (in which defects defined as primary or recurrent extensive disease where surgery and/or
exist in UV light-induced unscheduled DNA repair).45-51 RT may not result in a cure or would potentially yield a significant
functional limitation, should consider imaging to determine disease
extent. For rare cases when patients present with regional or distant
metastatic disease at diagnosis, imaging of areas of interest can be

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performed when there is suspicion of extensive disease prior to neoplasms based on 270 clinical scenarios including 69 BCCs,68 which
treatment as nodal or distant metastases. Imaging studies may be has been incorporated into Risk Factors for Recurrence within the
clinically evident when extensive disease, such as bone involvement, algorithm.
perineural invasion (PNI), or deep soft tissue involvement, is suspected.
If perineural disease is suspected, MRI with or without contrast is Clinical Borders and Primary Versus Recurrent Disease
preferred.56,57 If bone disease is suspected, CT with contrast is The low- and high-risk factors of well-defined versus ill-defined clinical
preferred unless contraindicated. Imaging modality and targeted area tumor borders69-71 and primary versus recurrent disease,62,70,72
should be at the discretion of the treating team based on the suspected respectively, have been extensively documented in the literature.
extent of disease (ie, local, regional, metastatic). Histologic confirmation
Immunosuppression
is sufficient to diagnose local recurrence, but MRI can be considered to
Settings of immunosuppression, such as organ transplantation,73-78 and
assess extent of local disease. For nodal or distant metastases,
long-term use of psoralen and UVA (PUVA) light,79,80 increase the
histologic analysis and/or CT imaging can be used for confirmation and
incidence of BCC. In particular, among patients who have had organ
to gauge the extent of disease.
transplants, BCC incidence is approximately 5- to 10-fold higher than in
History & Physical Examination the general population,81-83 occurring in up to half of patients during the
10 years following transplant.84-87 Several large retrospective studies
Location and Size
found that BCCs in patients who had received organ transplants were
Anatomic location58-64 and size60-66 have been known to be a risk factor
more likely to have the superficial histologic subtype and to occur in
for BCC recurrence and metastasis for many years. In general, BCCs
extracephalic locations and in younger patients (mean age of onset 15
that develop in the head and neck area, which includes the “H zone” or
years lower). 88-90 Two of these studies showed similar low recurrence
“mask area” of the face, are more likely to recur than those that develop
rates for transplant recipients and controls.89,90 Nevertheless, because
on the trunk and extremities. Based on a 27-year retrospective review of
of NCCN Guidelines Panel Members’ own anecdotal experiences, the
5755 BCCs, recurrences were significantly more common when tumors
panel decided to classify BCCs developing in settings of
in high-risk locations (central face, eyebrows, nose, lips, chin, ear,
immunosuppression as potentially high-risk tumors.
temple, genitalia, nipples/areola, hands, feet, ankles, and nail units)
were greater than or equal to 6 mm in diameter and when tumors in Site of Prior Radiotherapy
moderate-risk locations (cheeks, forehead, scalp, neck, jawline, pretibial Tumors developing in sites of prior RT refer to primary BCCs arising in
surface) were greater than or equal to 10 mm in diameter.67 The areas previously irradiated for unrelated conditions. All recurrent
American Academy of Dermatology in collaboration with American tumors, irrespective of prior therapy, are defined as high risk. Data from
College of Mohs Surgery, American Society for Dermatologic Surgery a number of studies with large sample sizes support that prior RT for
Association, and American Society for Mohs Surgery developed an
appropriate use criteria document in the treatment of cutaneous
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unrelated, frequently benign conditions is a risk factor for BCC Additionally, in the presence of PNI, a thorough cranial nerve exam is
development.23-27,91,92 indicated.

Pathology Age and Its Effect on BCC Behavior

Pathologic Subtypes Whether young age (typically ≤40 years) is an independent risk factor
Histologic subtyping of BCC as a predictor of risk of recurrence is a for aggressive BCC behavior is debatable. An analysis of a large
well-established concept.93,94 The subtypes encompassed by the term database of patients with BCC (N = 3381) documented an increased
“aggressive growth pattern,” including micronodular, infiltrative, percentage of BCC with aggressive histologic growth patterns in young
sclerosing, and morpheaform (or desmoplastic) patterns, are more likely persons.115 In contrast, results from other analyses of large databases
to recur than the nodular and superficial BCC.65,69,70,72,95-99 Non- (N = 1000 to >10,000) indicate that patients presenting with BCC at a
aggressive subtypes include the keratotic variant, infundibulocystic young age are more likely to have the superficial subtype.116-119 Other
variant, and fibroepithelioma of Pinkus. analyses report no significant differences in BCC histologic subtype
between young versus older patients.120-122 The relationship between
Basosquamous carcinomas are tumors that have the histologic tumor location and patient age is also unclear, as several studies
appearance of both a BCC and an SCC. Some basosquamous tumors showed that younger patients were more likely to present with BCCs on
are the result of a BCC colliding with an adjacent SCC. Others the trunk or extremities,116,121,123,124 while another found no significant
represent truly biphenotypic tumors, many of which may have started as association.120
BCC, but have subsequently undergone prominent partial squamous
metaplasia.100 Data suggest that basosquamous carcinomas have a Most large studies (N = 50-2000) have shown no significant association
metastatic capacity that is more similar to that of SCC than BCC.101-103 between age and recurrence rate.62,70,120,122 One multivariate analysis,
however, showed a positive relationship between increasing age and
Perineural Involvement likelihood of recurrence.125 Age has also been evaluated as a risk factor
PNI is uncommon in any nonmelanoma skin cancer (NMSC) (2%–6%), for developing a second or multiple BCCs and many of these studies
and develops less frequently and is less aggressive in BCC versus using fairly large databases (N = 200–2500) found that the risk of
SCC.104-109 BCC with PNI poses a greatly increased risk of recurrence, developing more than one BCC is associated with increased
and is associated with other risk factors including previous recurrent age.65,122,124-130 On the contrary, an analysis of a very large database (N
tumors, high grade, larger lesion size, and certain subtypes (infiltrating, = 71,924) found a significantly higher risk of subsequent NMSC in
morpheaform, and basosquamous).108,110,111 If large nerve involvement patients <40 years at the time of their first BCC diagnosis.131 In addition,
is suspected, MRI should be considered to evaluate extent and/or rule an analysis of 100 metastatic BCC cases found that patients with
out skull involvement in those with head and neck tumors.57,112-114 distant metastases tended to be younger than those with only regional
metastases.132 Consistent with this idea, the Rotterdam Study showed

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that while the risk of developing a second BCC increased with age,130 Treatment Modalities for BCC
the risk of developing multiple BCC lesions was highest in patients who Curettage and Electrodesiccation
were <65 years at the time of their first BCC diagnosis.133 Taken
Although a fast and cost-effective technique for superficial lesions,
together, these studies suggest that young age, in and of itself, is not
curettage and electrodesiccation (C&E) does not allow histologic margin
considered a risk factor for aggressive BCC. Nevertheless, there is a
assessment. Studies have reported overall 5-year recurrence rates
small subset of patients who develop BCC at a young age and may
ranging from 1.2% to 40% in patients with BCC selected for C&E, with
have particularly aggressive disease. These patients may benefit from
high-risk locations and histologically aggressive subtypes reporting
regular follow-up.
higher recurrence rates.60,134-143

This technique is deemed effective for properly selected, low-risk BCC

with three caveats.60,140 First, C&E should not be used to treat areas
with terminal hair growth such as the scalp, pubic and axillary regions,
or beard area due to the risk that a tumor extending down follicular
structures might not be adequately removed. Second, if the
subcutaneous layer is reached during the course of C&E, then surgical
removal should generally be performed instead. This change in therapy
is necessary as the effectiveness of the C&E technique rests on the
ability of the clinician to distinguish between firm, normal dermis, and
soft tumor tissue when using a sharp curette. Since subcutaneous
adipose is even softer than tumor tissue, the ability of the curette to
distinguish and, therefore, selectively and completely remove tumor
cells diminishes. Third, if C&E has been performed based only on the
appearance of a low-risk tumor, biopsy results of the tissue taken at the
time of C&E should be reviewed to make sure that there are no
high-risk pathologic features that would require additional therapy. For
tumors on the cheeks, forehead, scalp, neck, and pretibial that are less
than 6 mm in depth and confined to the dermis, C&E may be
considered as an alternative primary treatment option if Mohs
micrographic surgery (Mohs) or resection with peripheral and deep en

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face margin assessment (PDEMA) and standard excision are not The clinical margins chosen by the panel for the primary treatment of
feasible due to patient comorbidities. low-risk BCC are based on the work of Zitelli et al.167 Their analysis
indicated that for well-circumscribed BCC lesions smaller than 2 cm in
Shave Removal diameter, excision with 4-mm clinical margins should result in complete
Shave removal, the shaving of epidermal or dermal lesions, is a sharp removal in more than 95% of cases. The indications for this approach
removal by bowl-shaped slicing of the epidermal and dermal lesions, were also expanded to include re-excision of low-risk primary BCC if
without including fat, and does not require suture closure.144 Like C&E, positive margins are obtained after an initial excision with postoperative
there is concern for inaccurate margin status assessment with shave margin assessment. For high-risk BCC, standard excision with wider
removal.145 However, it is a recommended technique for low-risk BCCs surgical margins is recommended as the primary treatment. Due to the
located in the trunk or extremities. Shave removal studies have reported wide variability of clinical characteristics that may define a high-risk
0.5% to 30% rate of recurrence over a 3- to 5-year follow-up, multiple tumor, it is not feasible to recommend a defined margin for standard
tumors treated in single visits, and a risk for misdiagnosis of only 1%.144- excision of high-risk BCC. Kean awareness of the subclinical extension
147
of BCC is advised when selecting a treatment modality without
complete margin assessment for a high-risk tumor. These margins may
Standard Excision with Postoperative Margin Assessment need to be modified based on tumor- or patient-specific factors. When
Another therapeutic option for BCC is standard surgical excision standard excision with wider surgical margins yields positive margins,
followed by postoperative pathologic evaluation of margins. This Mohs or other forms of PDEMA or standard re-excision are
technique has been reported to achieve 5-year recurrence rates of 0.8% recommended (if PDEMA is not feasible).
to 17.4% for BCC, with lower recurrence rates associated with low-risk
tumors and higher recurrence rates associated with high-risk For either low-risk or high-risk BCC, when standard excision is used,
tumors.134,136,142,148-150 Studies have reported variable margins required tissue rearrangement (eg, flap reconstruction, extensive undermining)
to completely excise 95% of all tumor.151-156 These margins have been should not be undertaken until clear margins are identified. Second
suggested to be 2 to 4 mm for low-risk, well-demarcated tumors smaller intention healing, linear repair, or skin graft are acceptable options.
than 2 cm,151-155 whereas margins of 4 to 6 mm,152 and in one study, 8
Mohs Micrographic Surgery and Peripheral and Deep En
mm151 were suggested for high-risk BCC. Given this wide variability,
Face Margin Assessment
studies have reported incomplete excision rates after standard excision
Mohs is the preferred surgical technique over standard excision for re-
ranging from 3.2% to 61.5% depending on tumor location, histologic
excision of low-risk BCC after positive margins with standard excision,
subtype, and medical provider’s specialty.157-166 Therefore,
as well as the primary surgical technique of choice for high-risk BCC
postoperative margin assessment and identification of clear margins are
because it allows intraoperative analysis of 100% of the excision
critical to ensure favorable outcomes with standard excision.
margin. Mohs is also recommended when standard excision with wider

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surgical margins is unable to achieve negative margins in high-risk underscores the panel’s belief that complete histologic assessment of
BCC. Two meta-analyses published in 1989 associated Mohs with 5- the entire marginal surface is the key to optimal tumor removal. For
year recurrence rates of 1.0% for primary BCC, and 5.6% for recurrent more information, refer to the NCCN Guidelines for Squamous Cell Skin
BCC.134,142 In these studies, the recurrence rates for Mohs were lower Cancer SCC-G Principles of PDEMA Technique.
than those for standard excision (10.1% and 17.4% for primary and
recurrent BCC, respectively), and lower than those for any other
treatment modality included in the analysis (C&E, cryotherapy, and
RT).134,142 Studies on the long-term outcomes (~4 years) of Mohs have
reported overall recurrence rates of 2.9% to 3.8%,168,169 specifically 0%
to 6.5% for primary and 4% to 20% for recurrent BCCs.94,170-175 The only
prospective randomized trial comparing Mohs to standard excision
reported fewer 10-year recurrences with Mohs for both primary (2.5%
vs. 4.1%; P = .397) and recurrent BCC (2.4% vs. 12.1%; P = .015),
although the difference was only statistically significant for recurrent
tumors. Importantly, a large proportion of recurrences occurred more
than 5 years after treatment.143,176,177 Besides lower recurrence rates,
Mohs has also been associated with significant tissue sparing
compared with standard excision.178,179 It has been demonstrated that
H-zone location, recurrent tumor, aggressive subtype, PNI, and tumor
size greater than or equal to 11 mm are significantly associated with two
or more Mohs stages.110,180 However, superficial BCC, despite being
generally considered less aggressive, was shown in a Brazilian study to
be 9.03 times more likely to require more than one Mohs stage, likely
due to “skip areas” and clinically indistinct borders.181

Excision with PDEMA with permanent section analysis or intraoperative

frozen section analysis is an acceptable alternative to Mohs provided it
includes a complete assessment of all deep and peripheral margins. A
5-year recurrence rate of 0.58% has been reported with slow Mohs
using formalin-fixed paraffin-embedded sections and delayed closure in
a UK-based prospective study.182 The descriptive term PDEMA

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Radiation Therapy recurrence rates with RT than surgery (7.5% vs. 0.7%; P = .003),193
Although surgery is the mainstay of local treatment for BCC, poorer cosmetic outcomes, and more postoperative complications.194
consideration of function and patient preference and other factors may
A small number of prospective studies have reported high rates of
lead to the choice of RT as primary therapy for non-surgical candidates
tumor control with specific radiation dose fractionation regimens for
for both low-risk and high-risk as well as patient with advanced BCC
small BCCs.193,195,196 A systematic review and meta-analysis also
(locally advanced, nodal, and metastatic BCC).183 The
reported hypofractionated RT regimens associated with positive
recommendations for RT extend to additional treatment for low-risk
cosmetic outcomes.197 The NCCN Panel recommends ranges of
BCC after positive margins with standard excision. RT is also
electron beam dose and fractionation that can be used for definite RT
recommended for high-risk BCC as additional treatment after standard
and postoperative adjuvant RT. Isotope-based brachytherapy can be an
excision, Mohs, or other forms of PDEMA with positive margins and
effective treatment for certain sites of disease, particularly on the head
adjuvant treatment after negative margins in case of extensive
and neck.198-201 However, there are insufficient long-term efficacy and
perineural or large-nerve involvement.184 In these patients, local control
safety data to support the routine use of electronic surface
has been reported to be 50% to 90% with postoperative RT.183,185 There
brachytherapy.202,203
are conflicting data about the value of adjuvant RT following margin-
negative surgical excision, particularly after Mohs. For high-risk BCC Superficial Therapies
that has undergone multiple resections, and further surgery is not
In patients with superficial BCC, therapies such as topical imiquimod,
feasible, RT is recommended as part of multidisciplinary consultation if
topical 5-fluorouracil (5-FU), or photodynamic therapy (PDT) may be
residual disease is present. For specifics about the application of RT,
considered, although cure rates are approximately 10% lower than for
see Principles of Radiation Therapy within the algorithm.
surgical treatment modalities.204-206 Another option for patients with
Two meta-analyses reported 5-year recurrence rates of 8.7% and 9.8% superficial BCC is cryotherapy.207 These options are also
after RT on primary and recurrent BCC, respectively.134,142 recommended for patients where surgery or RT is contraindicated or
Retrospective analyses of BCC treated with RT have reported 5-year impractical.
local control, cure, or complete response rates ranging from 93% to
Topical Therapies
96%,186-189 and 5-year recurrence rates from 4% to 16%.190-192 Efficacy
Imiquimod was found to be effective for treating nodular and superficial
of RT was better for BCCs that were less advanced, primary (vs.
BCC in randomized studies.208-213 Two 5-year follow-up studies reported
recurrent), or had smaller diameter or nodular histologic
overall treatment success rates of 80.4% and 77.9%, respectively, in
subtype.186,187,189-191 A prospective study randomizing 347 patients to
patients with superficial BCC treated with imiquimod.212,214 Recurrence
receive either surgery (standard excision with free margins ≥2 mm from
seems to be associated with tumor thickness.215 A phase III randomized
visible borders) or RT as primary treatment of BCC reported higher
trial in patients with superficial or nodular BCC showed that imiquimod

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provided an 82.5% clinical success rate.216,217 For all of these studies, Cryotherapy
tumors in the H-zone were excluded. Although the clinical success rate Cryotherapy has been used for many years as a fast and cost-effective
was significantly higher with surgical excision using a 4-mm margin means for removal of BCCs.207 Systematic reviews of historical data in
(97.7%; P < .001), cosmetic outcomes by dermatologic assessment primary BCCs have reported recurrence rates for cryotherapy ranging
were significantly better with imiquimod (excellent/good at 3-year follow- from 0% to 13%, and mean recurrence rates from pooled analyses
up: 61% vs. 36%; P < .001). Another topical cream with efficacy against ranging between 3% and 4%.134,136,245,246 In prospective trials,
BCC is 5-FU,218,219 which has been shown in a large randomized trial to cryotherapy has been shown to result in recurrence rates ranging from
have a 5-year tumor-free survival probability of 70.0%.205,220,221 Other 5% to 39%.195,247-249 A key limitation of cryotherapy is poorer cosmetic
studies have reported cure rates of up to 90% with this treatment.222-224 outcomes compared with other treatment options, as demonstrated by
prospective randomized trials.248-250
Photodynamic Therapy
PDT with photosensitizing agents including 5-aminolevulinic acid (ALA) Comparisons of Superficial Therapies
and porfimer sodium is another option for superficial BCC.225-227 Multiple Several randomized studies and meta-analyses have compared
randomized trials and a meta-analysis have shown that rates of superficial therapies for BCC (Table 1). In summary, these studies
excellent or good cosmetic outcomes were higher with PDT versus indicate that in patients with superficial BCC, PDT has similar efficacy
surgery, although surgery was superior to PDT in terms of disease as cryotherapy but much better cosmetic outcomes. Whereas a meta-
control.149,228-235 Data from clinical trials reported cure rates from 60% to analysis of 23 randomized and non-randomized trials found no
100% by PDT for patients with BCC.231,236-241 Most of these studies have significant difference in efficacy for PDT versus imiquimod,251 a
focused on the superficial and nodular histologic subtypes, and several randomized trial showed that treatment success was more likely with
have found higher cure rates for superficial versus nodular subtypes in imiquimod.205,221 This study also demonstrates superior imiquimod
both low- and high-risk locations.231,236,241 Ulceration and thickness are outcomes compared to 5-FU cream. Exploratory sub-analyses found
associated with lower response to therapy,241 and within the nodular that treatment success rates were significantly higher with imiquimod for
subtype, cure rates are better with thinner lesions.230 Clinical studies tumors that are large or truncal, while PDT provided significantly better
have demonstrated PDT activity against “difficult-to-treat” lesions, with a outcomes in older patients with lesions on the lower extremities.252
24-month complete response rate of 78%.236,242 Currently, PDT is being Safety results showed that while PDT causes moderate to severe pain
used at some NCCN Member Institutions for premalignant or superficial during treatment administration, imiquimod and 5-FU are more likely to
low-risk lesions on any location on the body, although response rates cause moderate to severe local swelling, erosion, crust formation,
may be higher on the face and scalp.243,244 itching, and wound infections.220 Both cryotherapy and PDT are
associated with pain during and after treatment, and data from a
randomized trial indicate a trend toward a higher likelihood of pain with
PDT.248

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Nicotinamide in Reducing BCC Development from the ERIVANCE trial, an investigator-reported, multicenter, phase II
Data from phase II and phase III randomized trials indicated that trial, conveyed an objective response rate of 48.5% in the mBCC group
treatment of actinic keratoses with nicotinamide reduced the occurrence and 60.3% in the laBCC group, with a median DOR of 14.8 months and
of new BCCs, specifically by 20% at 12-month follow-up.253,254 This is 26.2 months for each group, respectively.261-264 Results from these trials
supported by data from another study.255 Other agents that might be for vismodegib in BCC are summarized in Table 2. According to these
effective for the prevention of BCC in individuals at high risk for data, nearly all patients treated with vismodegib experienced at least
developing NMSCs include celecoxib,256 acitretin,257 capecitabine,258 one treatment-emergent adverse event (TEAE), but a significant
and tazarotene.259 proportion of these were low grade (grade ≤2).261-263 Serious adverse
events (SAEs) occurred in 25% to 32% of patients in these studies. The
Systemic Therapy most common adverse events (AEs) included muscle spasms, alopecia,
For advanced BCC, systemic therapy is recommended as a treatment taste loss, weight loss, decreased appetite, fatigue, nausea, and
option for locally advanced (laBCC), metastatic (mBCC), and nodal diarrhea.
BCC after multidisciplinary consultation. Other options include surgery,
RT, and palliation and best supportive care for certain patients. The Vismodegib has also been tested as BCC treatment and prophylaxis in
systemic therapy options for BCC include hedgehog pathway inhibitor patients with nevoid BCC syndrome. A randomized phase II study in
(HHI) and immunotherapy. Vismodegib and cemiplimab are currently patients with nevoid BCC syndrome and at least 10 operable BCC
recommended options for all advanced BCCs while sonidegib is only lesions found that vismodegib significantly reduced incidence of new
recommended for nodal and laBCC. BCC lesions compared with placebo, and also significantly reduced the
size of existing lesions and the number of surgeries needed to remove
Hedgehog Pathway Inhibitors BCC lesions.265-267
Vismodegib is an HHI approved by the U.S. Food and Drug
Administration (FDA) for the treatment of adults with laBCC or mBCC Sonidegib is another HHI FDA-approved agent for the treatment of
that has recurred following surgery, or those who are not candidates for patients with laBCC that has recurred following surgery or RT, or who
surgery or RT.260 The 9-month follow-up data from the SHH4476g trial, are not candidates for surgery or RT.268 Sonidegib is FDA approved for
a centrally reported, multicenter, phase I, open-label study had an initial laBCC. The 42-month follow-up data from the centrally reported
enrollment of 104 patients (laBCC N = 71, mBCC N = 33); however, randomized, multicenter, phase II BOLT trial reported similar objective
pathology results excluded eight laBCC patients from the efficacy response rates for the 200-mg and 800-mg doses tested among
analysis (N = 63). This trial reported an objective response rate of 30% patients with laBCC (56% and 46%, respectively), while there was a 2-
in the mBCC group and 43% in the laBCC group, with a median fold difference for patients with mBCC (8% and 17%, respectively).269-273
duration of response (DOR) of 7.6 months and 9.5-month median This trial also reported, for each dose and patient group, median DOR
progression-free survival (PFS).261 A 39-month follow-up to these data and PFS results that are summarized in Table 2. The 30-month

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investigator-reviewed data for the BOLT trial analyzing only the 200-mg Other HHIs are also being tested in patients with BCC to see if they can
dose showed a higher objective response rate of 71.2% for laBCC and provide higher rates of response, more durable responses, responses in
23.1% for mBCC (Table 2).271,274 As with vismodegib, nearly all patients less advanced BCC, or responses in BCC resistant to vismodegib.
experienced at least one AE, and the most common AEs were muscle Results from phase I–II trials with small BCC sample sizes (N < 40)
spasms, dysgeusia, alopecia, nausea, weight decrease, and fatigue. have shown that itraconazole and saridegib can elicit responses in
Elevated creatinine kinase was also frequently observed and was one patients with BCC, although not in patients who previously received
of the most common grade 3–4 AEs, along with elevated lipase. vismodegib.282,283

A key limitation to HHI therapies is that advanced BCC can develop Immunotherapy
resistance, which limits the DOR. A small investigator-initiated trial in Cemiplimab-rwlc is an anti-PD-1 immunotherapy FDA-approved for
patients with vismodegib-resistant advanced BCC observed no patients with laBCC or mBCC previously treated with an HHI or for
responses during treatment with sonidegib for a median of 6 weeks whom an HHI is not appropriate.284 Cemiplimab is a recommended
(range, 3–58 weeks), and in 5 of 9 patients with disease progression.275 treatment option for certain patients with advanced BCC including in the
neoadjuvant setting for laBCC. A centrally reported, multicenter, phase
Ongoing clinical research is exploring various dosing regimens of II, open-label trial tested cemiplimab-rwlc (N = 84) for patients with
vismodegib and sonidegib in a variety of BCC treatment settings, laBCC where local invasion precluding complete resection or in
including in the neoadjuvant setting, in patients with multiple BCCs or locations for which surgery may result in sever disfigurement or
with radiation-induced multiple BCCs of the scalp, and as maintenance dysfunction and whose disease has progressed on or was intolerant to
therapy after laBCC complete remission.276-281 Notably, in the prior HHI therapy.285 This study reported a median follow-up of 15
neoadjuvant setting, while one trial reported negative results (unmet months, objective response rate of 31%, and grade 3–4 TEAEs in 48%
predefined complete histologic clearance rate),277 results from two of patients, while SAEs occurred in 35% of patients.285
studies indicated vismodegib may reduce surgical defect area and allow
for downstaging of the surgical procedure for laBCCs in functionally Due to the rarity of advanced cases, the literature on chemotherapy for
sensitive locations.276,279 The VISMEO trial, a centrally reported, phase BCC is limited to case reports.286-292
II, open-label study, had an enrollment of 55 patients with laBCC. This
study reported an objective response rate of 71%, with 36.4%
recurrence at the 3-year follow-up.279 Some of these studies included
small numbers of patients, and thus their results need to be carefully
interpreted.

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Follow-up treatment pathway for high-risk BCC should be followed. For locally
Follow-up for BCC should include a history and physical examination, advanced, nodal metastases, and distant metastases, the appropriate
along with a complete skin examination every 6 to 12 months for the path should be followed as found within Advanced BCC in the
first 5 years, and then at least annually for life. Imaging may be algorithm.
considered if clinical examination is insufficient for following the disease.
An estimated 30% to 50% of patients with BCC will develop another
Follow-up with a dermatologist is strongly recommended if any of the
BCC within 5 years.126,129,293-296 This represents a 10-fold increase in risk
following criteria are met: past or imminent solid organ, marrow, or
compared to the general population.294 Patients with a prior BCC are
hematopoietic cell transplant; one or more cutaneous melanomas in the
also at increased risk of developing SCC and cutaneous
past 5 years; or four or more NMSCs within the past 5 years.
melanoma.126,296 A prospective population-based cohort study found
Imaging modality and targeted area should be at the discretion of the that development of a second BCC is most likely during the short-term
treating team based on the suspected extent of disease (ie, local, follow-up period after diagnosis of the first lesion.133 Therefore, close
regional, metastatic). Histologic confirmation is sufficient to diagnose follow-up of patients with BCC in both the short- and long-term is
local recurrence, but imaging can be considered to assess extent of critical.
disease. As part of follow-up, the patients should be educated on sun
protection and self-examination. For local recurrence, the primary

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Table 1. Studies Comparing Superficial Therapies in Patients with Superficial BCC

Histologic Tumor Locations
Study Treatments (n) Efficacy Cosmetic Outcome
Subtype
Phase III randomized trial Superficial Trunk, limb, head, neck Cryosurgery (39) 1-year 15% } NS Excellent: 8% } P < .001
Wang 2001248 and nodular ALA-PDT (44) recurrence: 25% 50%

Randomized trial Superficial Trunk, limb, head, neck, Cryotherapy (58) 5-year 20% } NS Excellent: 16% } P = .00078
Basset-Seguin 2008249 face MAL-PDT (60) recurrence: 22% 60%
Meta-analysis Superficial Locations depend on Imiquimod (1088) 1-year 87% } NS
Roozeboom 2012251 individual studies PDT (934) tumor-free 84% NR
survival:
Randomized, single-blind, Superficial
non-inferiority trial
Jansen 2018205
Trunk, limb, head, neck MAL-PDT (202) Treatment
Imiquimod cream (198) successa:
Fluorouracil cream (201)
63% } P < .001
81%
70 } P = .04
} NS
Good/ 62% All comparisons NS
excellent: 61%
58%
MAL, methyl aminolevulinate; NR, not reported; NS, no statistically significant difference; PDT, photodynamic therapy.
aTreatment success was defined as the product of the percent of patients with clearance at 3 months by the percentage with sustained clearance during the next 9 months.

Table 2. Hedgehog Pathway Inhibitors in Advanced BCCa

Patients, n Objective Duration of Progression-free Overall Survival,
Study
Txb Response Rated Response, Medianc Survival, Medianc Medianc
Name and References Design laBCC mBCC laBCC mBCC laBCC mBCC laBCC mBCC laBCC mBCC
BOLT – 42-month follow-up Phase II Soni 200 mg 66 13 56% 8% 26.1 24.0 22.1 13.1 NR NR
NCT01327053269,270,272,273 RDB, CR Soni 800 mg 128 23 46% 17% 23.3 NE 24.9 11.1 NR NR
BOLT – 30-month follow-up Phase II 17.7–
Soni 200mg 66 13 71% 23.1% 15.7 NR NR NR NR
NCT01327053271,274 RBD, IR 18.4
SHH4476g – 9-month follow-up Phase I
Vismo 63 33 43% 30% 7.6 7.6 9.5 9.5 NR NR
NCT00833417261 OL, CR
ERIVANCE – 39-month follow-up Phase II
Vismo 63 33 60% 49% 26.2 14.8 12.9 9.3 NE 33.4
NCT00833417262-264 OL, IR
laBCC, locally advanced BCC; mBCC, metastatic BCC; CR, centrally reviewed; IR, investigator reviewed; NE, not reached; NR, not reported; OL, open-label; RDB, randomized double-blind;
Soni, sonidegib; Tx, treatment; Vismo, vismodegib.
aTrials included patients with advanced BCC that was inappropriate for surgery or RT.
bInhibitors were taken orally once daily. Vismodegib dose was 150 mg.
cTimes are reported in months.
dResponse criteria varied between studies.

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Basal Cell Skin Cancer
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NCCN Guidelines Version 3.2024

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NCCN Guidelines Version 3.2024

Basal Cell Skin Cancer
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Basal Cell Skin Cancer
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NCCN Guidelines Version 3.2024

Basal Cell Skin Cancer
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NCCN Guidelines Version 3.2024

Basal Cell Skin Cancer
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Basal Cell Skin Cancer
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Basal Cell Skin Cancer
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Basal Cell Skin Cancer
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