Expert Consensus on the Use of Prognostic Gene Expression Profiling Tests for the Management of Cutaneous Melanoma: Consensus from the Skin Cancer Prevention Working Group

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Abstract

Background

Prognostic assessment of cutaneous melanoma relies on historical, clinicopathological, and phenotypic risk factors according to American Joint Committee on Cancer(AJCC) and National Comprehensive Cancer Network (NCCN) guidelines but may not account for a patient’s individual additional genetic risk factors.

Objective

To review the available literature regarding commercially available gene expression profile (GEP) tests and their use in the management of cutaneous melanoma.

Methods

A literature search was conducted for original, English-language studies or meta-analyses published between 2010 and 2021 on commercially available GEP tests in cutaneous melanoma prognosis, clinical decision-making regarding sentinel lymph node biopsy, and real-world efficacy. After the literature review, the Skin Cancer Prevention Working Group, an expert panel of dermatologists with specialized training in melanoma and non-melanoma skin cancer diagnosis and management, utilized a modified Delphi technique to develop consensus statements regarding prognostic gene expression profile tests. Statements were only adopted with a supermajority vote of > 80%.

Results

The initial search identified 1064 studies/meta-analyses that met the search criteria. Of these, we included 21 original articles and meta-analyses that studied the 31-GEP test (DecisionDx-Melanoma; Castle Biosciences, Inc.), five original articles that studied the 11-GEP test (Melagenix; NeraCare GmbH), and four original articles that studied the 8-GEP test with clinicopathological factors (Merlin; 8-GEP + CP; SkylineDx B.V.) in this review. Six statements received supermajority approval and were adopted by the panel.

Conclusion

GEP tests provide additional, reproducible information for dermatologists to consider within the larger framework of the eighth edition of the AJCC and NCCN cutaneous melanoma guidelines when counseling regarding prognosis and when considering a sentinel lymph node biopsy.

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Most cited references 36

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A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.

Soonmyung Paik, Steven Shak, Gong Tang … (2004)

The likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor-positive tumors is poorly defined by clinical and histopathological measures. We tested whether the results of a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of 21 prospectively selected genes in paraffin-embedded tumor tissue would correlate with the likelihood of distant recurrence in patients with node-negative, tamoxifen-treated breast cancer who were enrolled in the National Surgical Adjuvant Breast and Bowel Project clinical trial B-14. The levels of expression of 16 cancer-related genes and 5 reference genes were used in a prospectively defined algorithm to calculate a recurrence score and to determine a risk group (low, intermediate, or high) for each patient. Adequate RT-PCR profiles were obtained in 668 of 675 tumor blocks. The proportions of patients categorized as having a low, intermediate, or high risk by the RT-PCR assay were 51, 22, and 27 percent, respectively. The Kaplan-Meier estimates of the rates of distant recurrence at 10 years in the low-risk, intermediate-risk, and high-risk groups were 6.8 percent (95 percent confidence interval, 4.0 to 9.6), 14.3 percent (95 percent confidence interval, 8.3 to 20.3), and 30.5 percent (95 percent confidence interval, 23.6 to 37.4). The rate in the low-risk group was significantly lower than that in the high-risk group (P<0.001). In a multivariate Cox model, the recurrence score provided significant predictive power that was independent of age and tumor size (P<0.001). The recurrence score was also predictive of overall survival (P<0.001) and could be used as a continuous function to predict distant recurrence in individual patients. The recurrence score has been validated as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative, estrogen-receptor-positive breast cancer. Copyright 2004 Massachusetts Medical Society.

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The Delphi Technique: Making Sense of Consensus

Chia-Chien Hsu, Brian Sandford (2007)

The Delphi technique is a widely used and accepted method for gathering data from respondents within their domain of expertise. The technique is designed as a group communication process which aims to achieve a convergence of opinion on a specific real-world issue. The Delphi process has been used in various fields of study such as program planning, needs assessment, policy determination, and resource utilization to develop a full range of alternatives, explore or expose underlying assumptions, as well as correlate judgments on a topic spanning a wide range of disciplines. The Delphi technique is well suited as a method for consensus-building by using a series of questionnaires delivered using multiple iterations to collect data from a panel of selected subjects. Subject selection, time frames for conducting and completing a study, the possibility of low response rates, and unintentionally guiding feedback from the respondent group are areas which should be considered when designing and implementing a Delphi study. Accessed 68,465 times on https://pareonline.net from August 30, 2007 to December 31, 2019. For downloads from January 1, 2020 forward, please click on the PlumX Metrics link to the right.

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Vital Signs: Melanoma Incidence and Mortality Trends and Projections — United States, 1982–2030

Gery Guy, Cheryll C Thomas, Trevor Thompson … (2015)

Background Melanoma incidence rates have continued to increase in the United States, and risk behaviors remain high. Melanoma is responsible for the most skin cancer deaths, with about 9,000 persons dying from it each year. Methods CDC analyzed current (2011) melanoma incidence and mortality data, and projected melanoma incidence, mortality, and the cost of treating newly diagnosed melanomas through 2030. Finally, CDC estimated the potential melanoma cases and costs averted through 2030 if a comprehensive skin cancer prevention program was implemented in the United States. Results In 2011, the melanoma incidence rate was 19.7 per 100,000, and the death rate was 2.7 per 100,000. Incidence rates are projected to increase for white males and females through 2019. Death rates are projected to remain stable. The annual cost of treating newly diagnosed melanomas was estimated to increase from $457 million in 2011 to $1.6 billion in 2030. Implementation of a comprehensive skin cancer prevention program was estimated to avert 230,000 melanoma cases and $2.7 billion in initial year treatment costs from 2020 through 2030. Conclusions If additional prevention efforts are not undertaken, the number of melanoma cases is projected to increase over the next 15 years, with accompanying increases in health care costs. Much of this morbidity, mortality, and health care cost can be prevented. Implications for Public Health Practice Substantial reductions in melanoma incidence, mortality, and cost can be achieved if evidence-based comprehensive interventions that reduce ultraviolet (UV) radiation exposure and increase sun protection are fully implemented and sustained.

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Author and article information

Contributors

Aaron S. Farberg: aaron.farberg@gmail.com

Journal

Journal ID (nlm-ta): Dermatol Ther (Heidelb)

Journal ID (iso-abbrev): Dermatol Ther (Heidelb)

Title: Dermatology and Therapy

Publisher: Springer Healthcare (Cheshire )

ISSN (Print): 2193-8210

ISSN (Electronic): 2190-9172

Publication date (Electronic): 30 March 2022

Publication date PMC-release: 30 March 2022

Publication date Collection: April 2022

Volume: 12

Issue: 4

Pages: 807-823

Affiliations

[1 ]GRID grid.486749.0, ISNI 0000 0004 4685 2620, Section of Dermatology, , Baylor Scott & White Health System, ; 2110 Research Row, Dallas, TX 75235 USA

[2 ]Dermatology Science and Research Foundation, Buffalo Grove, IL USA

[3 ]GRID grid.262863.b, ISNI 0000 0001 0693 2202, SUNY Downstate Health Sciences University, ; Brooklyn, NY USA

[4 ]Department of Dermatology, St. John’s Episcopal Hospital, Far Rockaway, NY USA

[5 ]GRID grid.240473.6, ISNI 0000 0004 0543 9901, Department of Dermatology, , Penn State College of Medicine, ; Hershey, PA USA

[6 ]OptumCare, Los Angeles, CA USA

[7 ]National Society for Cutaneous Medicine, New York, NY USA

[8 ]GRID grid.59734.3c, ISNI 0000 0001 0670 2351, Department of Dermatology, , Icahn School of Medicine at Mount Sinai, ; New York, NY USA

Article

Publisher ID: 709

DOI: 10.1007/s13555-022-00709-x

PMC ID: 9021351

PubMed ID: 35353350

SO-VID: fa53a8e9-fe3b-415f-b4df-abac6437fa26

License:

Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 8 February 2022

Date accepted : 4 March 2022

Custom metadata

ScienceOpen disciplines: Dermatology

Keywords: cutaneous melanoma,gene-expression profile,consensus,american joint committee on cancer 8th edition,prognostic staging,risk,prediction,sentinel lymph node,sentinel lymph node biopsy

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ScienceOpen disciplines: Dermatology

Keywords: cutaneous melanoma, gene-expression profile, consensus, american joint committee on cancer 8th edition, prognostic staging, risk, prediction, sentinel lymph node, sentinel lymph node biopsy

Expert Consensus on the Use of Prognostic Gene Expression Profiling Tests for the Management of Cutaneous Melanoma: Consensus from the Skin Cancer Prevention Working Group

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Abstract

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Karger: Dermatology

Most cited references 36

A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.

The Delphi Technique: Making Sense of Consensus

Vital Signs: Melanoma Incidence and Mortality Trends and Projections — United States, 1982–2030

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