Basal Cell Skin Cancer. NCCN Guidelines

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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®)

Basal Cell

Skin Cancer

Version 1.2016

Continue

NCCN.org

Version 1.2016, 10/26/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines ® and this illustration may not be reproduced in any form without the express written permission of NCCN ®.



NCCN Guidelines Index

Basal Cell TOC

Discussion


NCCN Guidelines Version 1.2016 Panel Members

Basal Cell Skin Cancer

Roy C. Grekin, MD ϖ ¶UCSF Helen Diller FamilyComprehensive Cancer Center

Kenneth Grossman, MD, PhD †Huntsman Cancer Institute atthe University of Utah

Susan Higgins, MD, MS ф Yale Cancer Center/Smilow Cancer Hospital

Alan L. Ho, MD, PhD †Memorial Sloan Kettering Cancer Center

Karl D. Lewis, MD †University of Colorado Cancer Center

Daniel D. Lydiatt, DDS, MD ¶ ζFred & Pamela Buffett Cancer Center

Kishwer S. Nehal, MD ϖ ¶Memorial Sloan Kettering Cancer Center

Paul Nghiem, MD, PhD ϖFred Hutchinson Cancer Research Center/SeattleCancer Care Alliance

Elise A. Olsen, MD ϖ Duke Cancer Institute

Chrysalyne D. Schmults, MD ϖDana-Farber/Brigham and Women’s Cancer Center Massachusetts General Hospital Cancer Center

Aleksandar Sekulic, MD, PhD ϖMayo Clinic Cancer Center

Ashok R. Shaha, MD ¶ ζ

Memorial Sloan Kettering Cancer Center

Wade L. Thorstad, MD §Siteman Cancer Center at Barnes-Jewish Hospital and WashingtonUniversity School of Medicine

Malika Tuli, MD ϖSt. Jude Children’s Research Hospital/University of TennesseeHealth Science Center

Marshall M. Urist, MD ¶University of Alabama at BirminghamComprehensive Cancer Center

Timothy S. Wang, MD ϖThe Sidney Kimmel ComprehensiveCancer Center at Johns Hopkins

Sandra L. Wong, MD, MS ¶University of MichiganComprehensive Cancer Center

John A. Zic, MD ϖ

Vanderbilt-Ingram Cancer Center

NCCN

Anita Engh, PhDKarin G. Hoffmann, RN, CCM Continue NCCN Guidelines Panel Disclosures

ϖ Dermatology ф Diagnostic/Interventional radiology¶ Surgery/Surgical oncologyζOtolaryngology≠ Pathology/Dermatopathology† Medical oncologyƿ Internal medicine§ Radiotherapy/Radiation oncology‡ Hematology/Hematology oncology

* Discussion Section Writing Committee

Christopher K. Bichakjian, MD/Chair ϖUniversity of MichiganComprehensive Cancer Center

Thomas Olencki, DO/Vice-Chair †The Ohio State University ComprehensiveCancer Center - James Cancer Hospitaland Solove Research Institute

Sumaira Z. Aasi, MD ϖStanford Cancer Institute

Murad Alam, MD ϖ ¶ ζRobert H. Lurie Comprehensive CancerCenter of Northwestern University

James S. Andersen, MD ¶City of HopeComprehensive Cancer Center

Daniel Berg, MD ϖFred Hutchinson Cancer ResearchCenter/Seattle Cancer Care Alliance

Glen M. Bowen, MD ϖHuntsman Cancer Instituteat the University of Utah

Richard T. Cheney, MD ≠

Roswell Park Cancer Institute

Gregory A. Daniels, MD, PhD ‡ ƿ

UC San Diego Moores Cancer Center

L. Frank Glass, MD ϖ ≠Moftt Cancer Center

Printed by Fernando Namuche on 12/27/2015 8:56:35 PM. For personal use only. Not approved for distribution. Copyright © 2015 National Comprehensive Cancer Network, Inc., All Rights Reserved.



Clinical Trials: NCCN believes thatthe best management for any cancerpatient is in a clinical trial.Participation in clinical trials isespecially encouraged.

To nd clinical trials online at NCCNMember Institutions, click here:nccn.org/clinical_trials/physician.html.

NCCN Categories of Evidence andConsensus: All recommendationsare category 2A unless otherwisespecied.

See NCCN Categories of Evidenceand 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 maynot be reproduced in any form without the express written permission of NCCN. ©2015.


NCCN Basal Cell Skin Cancer Panel Members

Summary of the Guidelines Updates

Basal Cell Skin Cancer (BCC)

BCC Clinical Presentation, Workup, and Risk Status (BCC-1)BCC Primary and Adjuvant Treatments• Low Risk (BCC-2)

• High Risk (BCC-3)

BCC Follow-up and Recurrence (BCC-4)

BCC Risk Factors for Recurrence (BCC-A)

Principles of Treatment for Basal Cell Skin Cancer (BCC-B)

Principles of Radiation Therapy for Basal Cell Skin Cancer (BCC-C)

NCCN Guidelines Version 1.2016 Table of Contents



Basal Cell TOC

Discussion





Basal Cell TOC

Discussion


UPDATES

NCCN Guidelines Version 1.2016 Updates


• Footnote “n” is new to this page: “Current FDA-approved hedgehog pathway inhibitors include vismodegib and sonidegib.”

• Footnote “o” is new to this page: “If no further skin cancers are identified in the first 2 years, then less frequent follow-up may be

appropriate.”

BCC-A• Footnote “1”:

Was added to “Area M <10 mm” under “Low Risk”, removed from “Area H ≥6 mm”, under “High Risk” and modied: “Location independent

of size may constitute high risk. in certain clinical settings.”

• Footnote “3” was revised: “Having morpheaform, basosquamous (metatypical), sclerosing, mixed inltrative, or micronodular features

is any portion of the tumor. In some cases basosquamous (metatypical) tumors may be prognostically similar to SCC. Clinicopathologic

consultation is recommended.”

Updates in Version 1.2016 of the NCCN Guidelines for Basal Cell Skin Cancer from Version 1.2015 include:


BCC-2• For “Primary treatment of low-risk basal cell skin cancer” under “Curettage and electrodesiccation”:Bullet 1 statement: “In non-hair bearing areas” revised: “Excluding terminal hair-bearing areas, such as scalp, pubic, axillary regions,

and beard area in men”.Bullet 2 statement: “If adipose reached, surgical excision should generally be performed”, an arrow was added pointing directly to

“Standard excision”.

BCC-3

• Under “Adjuvant Treatment”:

For “Standard excision” when margins are positive, a statement was modied: “If residual disease is present, and further surgery and RT

are contraindicated, consider multidisciplinary tumor board consultation (consider vismodegib a hedegehog pathway inhibitor or clinical

trials)”

For “Mohs or resection” as primary treatment when margins are positive, a statement was modied: “RT and/or multidisciplinary tumorboard consultation (consider a hedgehog pathway inhibitor or clinical trial)”

Footnote “n” added: “Current FDA approved hedgehog pathway inhibitors include vismodegib and sonidegib.”

BCC-4

• Under “Recurrence”:

“Regional” was removed and statement “Surgery and/or RT” was added to revised: “Nodal or distant metastases”

Statement revised: “Multidisciplinary tumor board consultation (consider a hedgehog pathway inhibitor vismodegib or clinical trials)”


P i t d b F d N h 12/27/2015 8 56 35 PM F l l N t d f di t ib ti C i ht © 2015 N ti l C h i C N t k I All Ri ht R d



Note: All recommendations are category 2A unless otherwise indicated.Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.


Basal Cell TOC

Discussion

NCCN Guidelines Version 1.2016



CLINICAL PRESENTATION WORKUP RISK STATUS

Suspicious lesion

• H&P

• Complete skin exam

• Biopsy

If more than supercial lesion,

inclusion of deep reticular

dermis preferreda

• Imaging studies as indicated for

suspicion of extensive diseaseb

Low riska

High riska,c

See Primary Treatment of Low-Risk

Basal Cell Skin Cancer (BCC-2)

See Primary Treatment of High-Risk

Basal Cell Skin Cancer (BCC-3)

aSee Risk Factors for Recurrence (BCC-A).bExtensive disease includes deep structural involvement such as bone, perineural disease, and deep soft tissue. If perineural disease is suspected, MRI is preferred.c Any high-risk factor places the patient in the high-risk category.

BCC-1


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Basal Cell TOC

Discussion



PRIMARY TREATMENTd ADJUVANT TREATMENT

Low-risk basal cell

skin cancer a,d

Curettage and electrodesiccation:

• Excluding terminal hair-bearing areas, such as scalp,pubic, axillary regions, and beard area in men

• If adipose reached, surgical excision should generally be

performed

or

Standard excision:

• If lesion can be excised with

4-mm clinical margins and

second intention healing,

linear repair, or skin grafte

or

RTf,g for non-surgical

candidates

Margins

Positive

Negative

Mohs or resection

with complete margin

assessmenth

or

Standard re-excision

for area L regionsi

or

RTffor non-surgical

candidatesSee Follow-up(BCC-4)

aSee Risk Factors for Recurrence (BCC-A).dSee Principles of Treatment for Basal Cell Skin Cancer (BCC-B).eClosures like adjacent tissue transfers, in which significant tissue rearrangement occurs, are best performed after clear margins are verified.f See Principles of Radiation Therapy for Basal Cell Skin Cancer (BCC-C).gRT often reserved for patients over 60 years because of concerns about long-term sequellae.hExcision with complete circumferential peripheral and deep margin assessment (CCPDMA) with frozen or permanent section is an alternative to Mohs surgery.i Area L = trunk and extremities (excluding pretibia, hands, feet, nail units, and ankles). (See BCC-A)

BCC-2








Basal Cell TOC

Discussion



BCC-3

PRIMARY TREATMENTd ADJUVANT TREATMENT

High-risk basal cell

skin cancer a,c,d,j

Standard excision

Wider surgical margins

with linear or delayed

repair are recommended

when excising high-risk

tumors with standard

re-excisione

Mohs or

resection with

complete margin

assessmenth

or

RTf,g for non-surgical

candidates

k

Margins

Margins

Positive

Negative

Negative

Positivel

Mohs or resection

with complete

marginassessmenth

or

RTf

If residual disease is

present, and further

surgery and RT arecontraindicated,

consider

multidisciplinary

tumor board

consultation

(consider a hedgehog

pathway inhibitor n or

clinical trial) See

Follow-up

(BCC-4)

aSee Risk Factors for Recurrence (BCC-A).c Any high-risk factor places the patient in the high-risk category.dSee Principles of Treatment for Basal Cell Skin Cancer (BCC-B).eClosures like adjacent tissue transfers, in which significant tissue rearrangement occurs, are best performed after clear margins are verified.f See Principles of Radiation Therapy for Basal Cell Skin Cancer (BCC-C).gRT often reserved for patients over 60 years because of concerns about long-term sequellae.hExcision with complete circumferential peripheral and deep margin assessment (CCPDMA) with frozen or permanent section is an alternative to Mohs surgery.

jFor complicated cases, consider multidisciplinary tumor board consultation.kIf surgery and RT are contraindicated, consider multidisciplinary tumor board consultation and therapy.lNegative margins unachievable by Mohs surgery or more extensive surgical procedures.mIf large nerve involvement is suspected, consider MRI to evaluate extent and rule out base of skull involvement.nCurrent FDA-approved hedgehog pathway inhibitors include vismodegib and sonidegib.

If extensive

perineural

or large-nerve

involvementm

recommendadjuvant RTf

RTf

and/or

Multidisciplinary tumor board consultation

(consider a hedgehog pathway inhibitor n or

clinical trial)

or

ted by e a do a uc e o / / 0 5 8 56 35 o pe so a use o y ot app o ed o d st but o Copy g t © 0 5 at o a Co p e e s e Ca ce et o , c , g ts ese ed




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

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



Basal Cell TOC

Discussion



FOLLOW-UP RECURRENCE

H&P

• Including complete skin exam

every 6-12 mo for lifeo

Patient education:

• Sun protection

• Self-examination

Local

Nodal or

distant metastases

Follow Primary Treatment Pathways (BCC-1)

BCC-4

kIf surgery and RT are contraindicated, consider multidisciplinary tumor board consultation and therapy.nCurrent FDA-approved hedgehog pathway inhibitors include vismodegib and sonidegib.oIf no further skin cancers are identified in the first 2 years, then less frequent follow-up may be appropriate.

Surgery and/or RTk

Multidisciplinary tumor board consultation

(consider a hedgehog pathway inhibitor n or

clinical trials)








Basal Cell TOC

Discussion



BCC-A

H&P

Location/size

Borders

Primary vs. Recurrent

Immunosuppression

Site of prior RT

Pathology

Subtype

Perineural involvement

RISK FACTORS FOR RECURRENCE

Low Risk

Area L <20 mm

Area M <10 mm1

Area H <6 mm1

Well dened

Primary

(-)

(-)

Nodular, supercial2

(-)

High Risk

Area L ≥20 mm

Area M ≥10 mm

Area H ≥6 mm

Poorly dened

Recurrent

(+)

(+)

Aggressive growth pattern3

(+)

Area H = “mask areas” of face (central face, eyelids, eyebrows, periorbital, nose, lips [cutaneous and vermilion], chin, mandible, preauricular and postauricular

skin/sulci, temple, ear), genitalia, hands, and feet.

Area M = cheeks, forehead, scalp, neck, and pretibia.

Area L = trunk and extremities (excluding pretibia, hands, feet, nail units, and ankles).

1Location independent of size may constitute high risk. 2Low risk histologic subtypes include nodular, superficial and other non-agressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus.3Having morpheaform, basosquamous (metatypical), sclerosing, mixed infiltrative, or micronodular features in any portion of the tumor. In some cases basosquamous (metatypical) tumors may be prognostically similar to SCC. Clinicopathologic consultation is recommended.








Basal Cell TOC

Discussion



BCC-B

• The goal of primary treatment of basal cell skin cancer is the cure 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. Customary age and size parameters may have to be modied.

• Surgical approaches often offer the most effective and efcient means for accomplishing cure, but considerations of function,

cosmesis, and patient preference may lead to choosing radiation therapy as primary treatment in order to achieve optimal overallresults.

• In certain patients at high risk for multiple primary tumors, increased surveillance and consideration of prophylactic measures

may be indicated.

• In patients with low-risk, supercial basal cell skin cancer, where surgery or radiation is contraindicated or impractical, topical

therapies such as 5-uorouracil, imiquimod, photodynamic therapy (eg, aminolevulinic acid [ALA], pormer sodium), or vigorous

cryotherapy may be considered, even though the cure rate may be lower.

PRINCIPLES OF TREATMENT FOR BASAL CELL SKIN CANCER








Basal Cell TOC

Discussion



BCC-C

PRINCIPLES OF RADIATION THERAPY FOR BASAL CELL SKIN CANCER

Tumor Diameter

<2 cm

Margins

1–1.5 cm1

Examples of Electron Beam Dose and Fractionation

64 Gy in 32 fractions over 6–6.4 weeks2

55 Gy in 20 fractions over 4 weeks


35 Gy in 5 fractions over 5 days

Dose and Field Size

≥2 cm 1.5–2 cm1 66 Gy in 33 fractions over 6–6.6 weeks55 Gy in 20 fractions over 4 weeks

Postoperative adjuvant 50 Gy in 20 fractions over 4 weeks


• Protracted fractionation is associated with improved cosmetic results.

• Radiation therapy is contraindicated in genetic conditions predisposing to skin cancer(eg, basal cell nevus syndrome, xeroderma pigmentosum) and connective tissue diseases (eg, scleroderma)

1When using electron beam, wider field margins are necessary than with orthovoltage x-rays due to the wider beam penumbra. Tighter field margins can be usedwith electron beam adjacent to critical structures (eg, the orbit) if lead skin collimation is used. Bolus is necessary when using electron beam to achieve adequatesurface dose. An electron beam energy should be chosen which achieves adequate surface dose and encompasses the deep margin of the tumor by at least thedistal 90% line. Appropriate medical physics support is essential.

2Electron beam doses are specified at 90% of the maximal depth dose (Dmax). Orthovoltage x-ray doses are specified at Dmax (skin surface) to account for the

relative biologic difference between the two modalities of radiation.













































NCCN Guidelines IndexNCCN Guidelines Version 1.2016




Version 1.2016, 10/26/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. MS-23

NCCN Guidelines IndexBCC Table of Contents

Discussion

NCCN Guidelines Version 1.2016Basal Cell Skin Cancer

Unresectable Squamous Cell Carcinoma of the Skin. J Clin Oncol

2011;29:3419-3426. Available at:http://www.ncbi.nlm.nih.gov/pubmed/21810686.

139. Perez CA, Song H, Raez LE, et al. Phase II study of gefitinibadaptive dose escalation to skin toxicity in recurrent or metastaticsquamous cell carcinoma of the head and neck. Oral Oncol2012;48:887-892. Available at:http://www.ncbi.nlm.nih.gov/pubmed/22513208.

140. Brewster AM, Lee JJ, Clayman GL, et al. Randomized trial ofadjuvant 13-cis-retinoic acid and interferon alfa for patients withaggressive skin squamous cell carcinoma. J Clin Oncol 2007;25:1974-1978. Available at: http://www.ncbi.nlm.nih.gov/pubmed/17513803.

141. Guthrie TH, Jr., Porubsky ES, Luxenberg MN, et al. Cisplatin-based chemotherapy in advanced basal and squamous cell carcinomasof the skin: results in 28 patients including 13 patients receiving

multimodality therapy. J Clin Oncol 1990;8:342-346. Available at:http://www.ncbi.nlm.nih.gov/pubmed/2405109.

142. Denic S. Preoperative treatment of advanced skin carcinoma withcisplatin and bleomycin. Am J Clin Oncol 1999;22:32-34. Available at:http://www.ncbi.nlm.nih.gov/pubmed/10025376.

143. Neuburg M. Transplant-associated skin cancer: role of reducingimmunosuppression. J Natl Compr Canc Netw 2007;5:541-549.

Available at: http://www.ncbi.nlm.nih.gov/pubmed/17509256.

144. Robinson JK. Follow-up and prevention (basal cell carcinoma). In:Miller SJ, Maloney ME, eds. Cutaneous Oncology Pathophysiology,diagnosis, and management. Malden, MA: Blackwell Science;1998:695-698.

145. Marcil I, Stern RS. Risk of developing a subsequent nonmelanomaskin cancer in patients with a history of nonmelanoma skin cancer: a

critical review of the literature and meta-analysis. Arch Dermatol

2000;136:1524-1530. Available at:

http://www.ncbi.nlm.nih.gov/pubmed/11115165.

146. Shin DM, Maloney ME, Lippman SM. Follow-up and prevention(squamous cell carcinoma). In: Miller SJ, Maloney ME, eds. CutaneousOncology Pathophysiology, diagnosis, and management. Malden, MA:Blackwell Science; 1998.

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Basal Cell Skin Cancer. NCCN Guidelines