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Early Detection and Prognostic Assessment of Cutaneous MelanomaConsensus on Optimal Practice and the Role of Gene Expression Profile Testing

To identify the key insights or developments described in this article
1 Credit CME
Key Points

Question  What are the recommended methods for early detection and prognostic assessment of cutaneous melanoma?

Findings  In this consensus statement, via a modified Delphi method, melanoma experts supported a risk-stratified approach to various aspects of melanoma screening as well as the use of visual and dermoscopic examination, the interpretation of reflectance confocal microscopy, and some uses of epidermal tape stripping. They did not, based on available evidence, reach consensus on the role for gene expression profile testing in clinical decision-making.

Meaning  The study results suggest that a risk-stratified approach to melanoma screening may be most appropriate; the role of molecular-based diagnostic and prognostic tests in cutaneous melanoma is evolving.

Abstract

Importance  Therapy for advanced melanoma has transformed during the past decade, but early detection and prognostic assessment of cutaneous melanoma (CM) remain paramount goals. Best practices for screening and use of pigmented lesion evaluation tools and gene expression profile (GEP) testing in CM remain to be defined.

Objective  To provide consensus recommendations on optimal screening practices and prebiopsy diagnostic, postbiopsy diagnostic, and prognostic assessment of CM.

Evidence Review  Case scenarios were interrogated using a modified Delphi consensus method. Melanoma panelists (n = 60) were invited to vote on hypothetical scenarios via an emailed survey (n = 42), which was followed by a consensus conference (n = 51) that reviewed the literature and the rationale for survey answers. Panelists participated in a follow-up survey for final recommendations on the scenarios (n = 45).

Findings  The panelists reached consensus (≥70% agreement) in supporting a risk-stratified approach to melanoma screening in clinical settings and public screening events, screening personnel recommendations (self/partner, primary care provider, general dermatologist, and pigmented lesion expert), screening intervals, and acceptable appointment wait times. Participants also reached consensus that visual and dermoscopic examination are sufficient for evaluation and follow-up of melanocytic skin lesions deemed innocuous. The panelists reached consensus on interpreting reflectance confocal microscopy and some but not all results from epidermal tape stripping, but they did not reach consensus on use of certain pigmented lesion evaluation tools, such as electrical impedance spectroscopy. Regarding GEP scores, the panelists reached consensus that a low-risk prognostic GEP score should not outweigh concerning histologic features when selecting patients to undergo sentinel lymph node biopsy but did not reach consensus on imaging recommendations in the setting of a high-risk prognostic GEP score and low-risk histology and/or negative nodal status.

Conclusions and Relevance  For this consensus statement, panelists reached consensus on aspects of a risk-stratified approach to melanoma screening and follow-up as well as use of visual examination and dermoscopy. These findings support a practical approach to diagnosing and evaluating CM. Panelists did not reach consensus on a clearly defined role for GEP testing in clinical decision-making, citing the need for additional studies to establish the clinical use of existing GEP assays.

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Article Information

Accepted for Publication: January 16, 2023.

Published Online: March 15, 2023. doi:10.1001/jamadermatol.2023.0127

Corresponding Author: John M. Kirkwood, MD, University of Pittsburgh, School of Medicine, Melanoma & Skin Cancer Disease Program, UPMC Hillman Cancer Center, UPMC Hillman Cancer Center, 5117 Centre Ave, Ste 1.32, Pittsburgh, PA 15213 (kirkwoodjm@upmc.edu).

Author Contributions: Dr Kirkwood had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Kashani-Sabet, Leachman, and Stein contributed equally to the writing of the manuscript.

Concept and design: Kirkwood, Kashani-Sabet, Leachman, Stein, Arbiser, Grant-Kels, Nelson, Tsao, Karapetyan, Savory, Sondak.

Acquisition, analysis, or interpretation of data: Kirkwood, Kashani-Sabet, Leachman, Stein, Berry, Celebi, Curiel-Lewandrowski, MD, Ferris, Grant-Kels, Grossman, Kulkarni, Marchetti, Polsky, Seiverling, Swetter, Tsao, Verdieck-Devlaeminck, Wei, Bar, Bartlett, Bolognia, Bowles, Cha, Chu, Hartman, Hawryluk, Jampel, Kheterpal, Lawson, Leming, Liebman, Ming, Sahni, Shaikh, Sober, Sondak, Spaccarelli, Usatine, Venna.

Drafting of the manuscript: Kirkwood, Kashani-Sabet, Leachman, Stein, Arbiser, Seiverling, Tsao, Verdieck-Devlaeminck, Karapetyan, Sahni.

Critical revision of the manuscript for important intellectual content: Kirkwood, Kashani-Sabet, Leachman, Stein, Arbiser, Berry, Celebi, Curiel-Lewandrowski, MD, Ferris, Grant-Kels, Grossman, Kulkarni, Marchetti, Nelson, Polsky, Seiverling, Swetter, Tsao, Wei, Bar, Bartlett, Bolognia, Bowles, Cha, Chu, Hartman, Hawryluk, Jampel, Karapetyan, Kheterpal, Lawson, Leming, Liebman, Ming, Sahni, Savory, Shaikh, Sober, Sondak, Spaccarelli, Usatine, Venna.

Obtained funding: Kirkwood.

Administrative, technical, or material support: Kirkwood, Leachman, Arbiser, Curiel-Lewandrowski, MD, Grant-Kels, Nelson, Bolognia, Bowles, Lawson, Sahni, Shaikh.

Supervision: Kirkwood, Kashani-Sabet, Leachman, Arbiser, Grant-Kels, Tsao, Kheterpal.

Other - participated in creating the data: Sober.

Conflict of Interest Disclosures: Dr Kirkwood reported grants from DermTech Inc outside the submitted work. Dr Kashani-Sabet reported stock in Melanoma Diagnostics, ownership interest in DNARX LLC, a patent issued for molecular classification of melanoma, and advisory board service for Bristol-Myers Squibb outside the submitted work. Dr Leachman reported honorarium from the Melanoma Research Foundation during the conduct of the study and research support from Castle Biosciences, Sklip Inc, Orlucent Inc, MAB, and VeriSkin Inc outside the submitted work. Dr Stein reported financial support from MoleSafe USA during the conduct of the study. Dr Berry reported personal fees from Melanoma Research Alliance during the conduct of the study as well as personal fees from Bristol Myers Squibb and Barco Inc outside the submitted work. Dr Celebi reported personal fees from NYU Grossman School of Medicine during the conduct of the study. Dr Curiel-Lewandrowski reports grants from Amgen outside the submitted work. Dr Ferris reported personal fees and grants from Derm Tech and grants from Castle Biosciences outside the submitted work. Dr Grossman reported research support from Derm Tech, Orlucent Inc, and Skin Analytics and personal fees from Orlucent Inc outside the submitted work. Dr Seiverling reported personal fees from DermaSensor Consultant for image quality review outside the submitted work. Dr Wei reported personal fees from Merck outside the submitted work. Dr Bar reported research support from Castle and personal fees from Regeneron during the conduct of the study and outside the submitted work. Dr Bartlett reported grants from SkylineDx and personal fees from Excite International LLC outside the submitted work. Dr Bolognia reported royalties from Elsevier outside the submitted work. Dr Bowles reported research support from Genentech, Amgen, Replimune, and Natera outside the submitted work. Dr Hartman reported grants from DermaSensor outside the submitted work. Dr Hawryluk reported being an author and reviewer for UpToDate outside the submitted work. Dr Savory reported being a board member for the Texas Dermatological Society. Dr Sondak reported personal fees from AMLo Biosciences, Alkermes, Bristol Myers Squibb, Genesis Drug Discovery & Development, Iovance, Merck, Novartis, Regeneron, and Ultimovacs; grants from Neogene Therapeutics and Turnstone; and nonfinancial support from SkylineDX outside the submitted work. No other disclosures were reported.

Funding/Support: The funding for the administration and facilitation of the consensus development conference and the development of thismanuscript was provided by Dermtech Inc in an unrestricted award that was administratively overseen by the Melanoma Research Foundation and managed and executed at UPMC by the principal investigato (Dr Kirkwood). DermTech was not involved in the preparation or editing of the manuscript.

Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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