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2. Early Detection and Prognostic Assessment of Cutaneous Melanoma

Author

Kashani-Sabet, Mohammed, Leachman, Sancy A, Stein, Jennifer A, Arbiser, Jack L, Berry, Elizabeth G, Celebi, Julide T, Curiel-Lewandrowski, Clara, Ferris, Laura K, Grant-Kels, Jane M, Grossman, Douglas, Kulkarni, Rajan P, Marchetti, Michael A, Nelson, Kelly C, Polsky, David, Seiverling, Elizabeth V, Swetter, Susan M, Tsao, Hensin, Verdieck-Devlaeminck, Alexandra, Wei, Maria L, Bar, Anna, Bartlett, Edmund K, Bolognia, Jean L, Bowles, Tawnya L, B., Kelly, Chu, Emily Y, Hartman, Rebecca I, Hawryluk, Elena B, Jampel, Risa M, Karapetyan, Lilit, Kheterpal, Meenal, Lawson, David H, Leming, Philip D, Liebman, Tracey N, Ming, Michael E, Sahni, Debjani, Savory, Stephanie A, Shaikh, Saba S, Sober, Arthur J, Sondak, Vernon K, Spaccarelli, Natalie, Usatine, Richard P, Venna, Suraj, and Kirkwood, John M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Cancer, Clinical Research, Health Services, Prevention, 4.2 Evaluation of markers and technologies, 4.1 Discovery and preclinical testing of markers and technologies, Humans, Skin Neoplasms, Melanoma, Prognosis, Transcriptome, Public Health, Risk Assessment, Melanoma, Cutaneous Malignant, Oncology and Carcinogenesis
Abstract

ImportanceTherapy 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.ObjectiveTo provide consensus recommendations on optimal screening practices and prebiopsy diagnostic, postbiopsy diagnostic, and prognostic assessment of CM.Evidence reviewCase 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).FindingsThe 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 relevanceFor 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.

Published
2023

3. Prognostic Gene Expression Profiling in Cutaneous Melanoma

Author

Grossman, Douglas, Okwundu, Nwanneka, Bartlett, Edmund K, Marchetti, Michael A, Othus, Megan, Coit, Daniel G, Hartman, Rebecca I, Leachman, Sancy A, Berry, Elizabeth G, Korde, Larissa, Lee, Sandra J, Bar-Eli, Menashe, Berwick, Marianne, Bowles, Tawnya, Buchbinder, Elizabeth I, Burton, Elizabeth M, Chu, Emily Y, Curiel-Lewandrowski, Clara, Curtis, Julia A, Daud, Adil, Deacon, Dekker C, Ferris, Laura K, Gershenwald, Jeffrey E, Grossmann, Kenneth F, Hu-Lieskovan, Siwen, Hyngstrom, John, Jeter, Joanne M, Judson-Torres, Robert L, Kendra, Kari L, Kim, Caroline C, Kirkwood, John M, Lawson, David H, Leming, Philip D, Long, Georgina V, Marghoob, Ashfaq A, Mehnert, Janice M, Ming, Michael E, Nelson, Kelly C, Polsky, David, Scolyer, Richard A, Smith, Eric A, Sondak, Vernon K, Stark, Mitchell S, Stein, Jennifer A, Thompson, John A, Thompson, John F, Venna, Suraj S, Wei, Maria L, and Swetter, Susan M

Subjects
Cancer, Clinical Research, Patient Safety, Prevention, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Good Health and Well Being, Clinical Decision-Making, Consensus, Consensus Development Conferences as Topic, Gene Expression Profiling, Humans, Melanoma, Neoplasm Staging, Practice Guidelines as Topic, Prognosis, Sentinel Lymph Node Biopsy, Skin Neoplasms, Clinical Sciences, Oncology and Carcinogenesis
Abstract

ImportanceUse of prognostic gene expression profile (GEP) testing in cutaneous melanoma (CM) is rising despite a lack of endorsement as standard of care.ObjectiveTo develop guidelines within the national Melanoma Prevention Working Group (MPWG) on integration of GEP testing into the management of patients with CM, including (1) review of published data using GEP tests, (2) definition of acceptable performance criteria, (3) current recommendations for use of GEP testing in clinical practice, and (4) considerations for future studies.Evidence reviewThe MPWG members and other international melanoma specialists participated in 2 online surveys and then convened a summit meeting. Published data and meeting abstracts from 2015 to 2019 were reviewed.FindingsThe MPWG members are optimistic about the future use of prognostic GEP testing to improve risk stratification and enhance clinical decision-making but acknowledge that current utility is limited by test performance in patients with stage I disease. Published studies of GEP testing have not evaluated results in the context of all relevant clinicopathologic factors or as predictors of regional nodal metastasis to replace sentinel lymph node biopsy (SLNB). The performance of GEP tests has generally been reported for small groups of patients representing particular tumor stages or in aggregate form, such that stage-specific performance cannot be ascertained, and without survival outcomes compared with data from the American Joint Committee on Cancer 8th edition melanoma staging system international database. There are significant challenges to performing clinical trials incorporating GEP testing with SLNB and adjuvant therapy. The MPWG members favor conducting retrospective studies that evaluate multiple GEP testing platforms on fully annotated archived samples before embarking on costly prospective studies and recommend avoiding routine use of GEP testing to direct patient management until prospective studies support their clinical utility.Conclusions and relevanceMore evidence is needed to support using GEP testing to inform recommendations regarding SLNB, intensity of follow-up or imaging surveillance, and postoperative adjuvant therapy. The MPWG recommends further research to assess the validity and clinical applicability of existing and emerging GEP tests. Decisions on performing GEP testing and patient management based on these results should only be made in the context of discussion of testing limitations with the patient or within a multidisciplinary group.

Published
2020

4. Erratum: Jeter JM, Bowles TL, Curiel‐Lewandrowski C, et al. Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials. Cancer. 2019:125:18‐44.

Author

Jeter, Joanne M, Bowles, Tawnya L, Curiel-Lewandrowski, Clara, Swetter, Susan M, Filipp, Fabian V, Abdel-Malek, Zalfa A, Geskin, Larisa J, Brewer, Jerry D, Arbiser, Jack L, Gershenwald, Jeffrey E, Chu, Emily Y, Kirkwood, John M, Box, Neil F, Funchain, Pauline, Fisher, David E, Kendra, Kari L, Marghoob, Ashfaq A, Chen, Suephy C, Ming, Michael E, Albertini, Mark R, Vetto, John T, Margolin, Kim A, Pagoto, Sherry L, Hay, Jennifer L, Grossman, Douglas, Ellis, Darrel L, Kashani-Sabet, Mohammed, Mangold, Aaron R, Markovic, Svetomir N, Meyskens, Frank L Jr, Nelson, Kelly C, Powers, Jennifer G, Robinson, June K, Sahni, Debjani, Sekulic, Aleksandar, Sondak, Vernon K, Wei, Maria L, Zager, Jonathan S, Dellavalle, Robert P, Thompson, John A, Weinstock, Martin A, Leachman, Sancy A, and Cassidy, Pamela B

Subjects
Oncology and Carcinogenesis, Public Health and Health Services, Oncology & Carcinogenesis
Published
2019

5. Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials

Author

Jeter, Joanne M, Bowles, Tawnya L, Curiel-Lewandrowski, Clara, Swetter, Susan M, Filipp, Fabian V, Abdel-Malek, Zalfa A, Geskin, Larisa J, Brewer, Jerry D, Arbiser, Jack L, Gershenwald, Jeffrey E, Chu, Emily Y, Kirkwood, John M, Box, Neil F, Funchain, Pauline, Fisher, David E, Kendra, Kari L, Marghoob, Ashfaq A, Chen, Suephy C, Ming, Michael E, Albertini, Mark R, Vetto, John T, Margolin, Kim A, Pagoto, Sherry L, Hay, Jennifer L, Grossman, Douglas, Ellis, Darrel L, Kashani-Sabet, Mohammed, Mangold, Aaron R, Markovic, Svetomir N, Meyskens, Frank L, Nelson, Kelly C, Powers, Jennifer G, Robinson, June K, Sahni, Debjani, Sekulic, Aleksandar, Sondak, Vernon K, Wei, Maria L, Zager, Jonathan S, Dellavalle, Robert P, Thompson, John A, Weinstock, Martin A, Leachman, Sancy A, and Cassidy, Pamela B

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Clinical Trials and Supportive Activities, Prevention, Cancer, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, 3.3 Nutrition and chemoprevention, 6.9 Resources and infrastructure (treatment evaluation), Animals, Anticarcinogenic Agents, Chemoprevention, Clinical Trials, Phase III as Topic, Drug Development, Drug Repositioning, Female, Humans, Male, Melanoma, Radiation-Protective Agents, Skin Neoplasms, biomarkers, chemoprevention, human model systems, melanoma, natural products, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

Recent progress in the treatment of advanced melanoma has led to unprecedented improvements in overall survival and, as these new melanoma treatments have been developed and deployed in the clinic, much has been learned about the natural history of the disease. Now is the time to apply that knowledge toward the design and clinical evaluation of new chemoprevention agents. Melanoma chemoprevention has the potential to reduce dramatically both the morbidity and the high costs associated with treating patients who have metastatic disease. In this work, scientific and clinical melanoma experts from the national Melanoma Prevention Working Group, composed of National Cancer Trials Network investigators, discuss research aimed at discovering and developing (or repurposing) drugs and natural products for the prevention of melanoma and propose an updated pipeline for translating the most promising agents into the clinic. The mechanism of action, preclinical data, epidemiological evidence, and results from available clinical trials are discussed for each class of compounds. Selected keratinocyte carcinoma chemoprevention studies also are considered, and a rationale for their inclusion is presented. These data are summarized in a table that lists the type and level of evidence available for each class of agents. Also included in the discussion is an assessment of additional research necessary and the likelihood that a given compound may be a suitable candidate for a phase 3 clinical trial within the next 5 years.

Published
2019

26. Association between halo nevi and melanoma in adults: A multicenter retrospective case series

Author

Haynes, Dylan, Strunck, Jennifer L., Said, Jordan, Tam, Idy, Varedi, Amir, Topham, Christina A., Olamiju, Brianna, Wei, Brian M., Erickson, Maia K., Wang, Leo L., Tan, Andrea, Stoner, Ryan, Hartman, Rebecca I., Lilly, Evelyn, Grossman, Douglas, Curtis, Julia A., Westerdahl, John S., Leventhal, Jonathan S., Choi, Jennifer N., Chu, Emily Y., Ming, Michael E., Stein, Jennifer A., Liebman, Tracey N., Berry, Elizabeth, and Greiling, Teri M.

Published
2021
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27. Addressing the Knowledge Gap in Clinical Recommendations for Management and Complete Excision of Clinically Atypical Nevi/Dysplastic Nevi: Pigmented Lesion Subcommittee Consensus Statement

Author

Kim, Caroline C., Swetter, Susan M., Curiel-Lewandrowski, Clara, Grichnik, James M., Grossman, Douglas, Halpern, Allan C., Kirkwood, John M., Leachman, Sancy A., Marghoob, Ashfaq A., Ming, Michael E., Nelson, Kelly C., Veledar, Emir, Venna, Suraj S., and Chen, Suephy C.

Published
2015
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32. Prognostic Gene Expression Profiling in Cutaneous Melanoma: Identifying the Knowledge Gaps and Assessing the Clinical Benefit.

Author

Grossman, Douglas, Grossman, Douglas, Okwundu, Nwanneka, Bartlett, Edmund K, Marchetti, Michael A, Othus, Megan, Coit, Daniel G, Hartman, Rebecca I, Leachman, Sancy A, Berry, Elizabeth G, Korde, Larissa, Lee, Sandra J, Bar-Eli, Menashe, Berwick, Marianne, Bowles, Tawnya, Buchbinder, Elizabeth I, Burton, Elizabeth M, Chu, Emily Y, Curiel-Lewandrowski, Clara, Curtis, Julia A, Daud, Adil, Deacon, Dekker C, Ferris, Laura K, Gershenwald, Jeffrey E, Grossmann, Kenneth F, Hu-Lieskovan, Siwen, Hyngstrom, John, Jeter, Joanne M, Judson-Torres, Robert L, Kendra, Kari L, Kim, Caroline C, Kirkwood, John M, Lawson, David H, Leming, Philip D, Long, Georgina V, Marghoob, Ashfaq A, Mehnert, Janice M, Ming, Michael E, Nelson, Kelly C, Polsky, David, Scolyer, Richard A, Smith, Eric A, Sondak, Vernon K, Stark, Mitchell S, Stein, Jennifer A, Thompson, John A, Thompson, John F, Venna, Suraj S, Wei, Maria L, Swetter, Susan M, Grossman, Douglas, Grossman, Douglas, Okwundu, Nwanneka, Bartlett, Edmund K, Marchetti, Michael A, Othus, Megan, Coit, Daniel G, Hartman, Rebecca I, Leachman, Sancy A, Berry, Elizabeth G, Korde, Larissa, Lee, Sandra J, Bar-Eli, Menashe, Berwick, Marianne, Bowles, Tawnya, Buchbinder, Elizabeth I, Burton, Elizabeth M, Chu, Emily Y, Curiel-Lewandrowski, Clara, Curtis, Julia A, Daud, Adil, Deacon, Dekker C, Ferris, Laura K, Gershenwald, Jeffrey E, Grossmann, Kenneth F, Hu-Lieskovan, Siwen, Hyngstrom, John, Jeter, Joanne M, Judson-Torres, Robert L, Kendra, Kari L, Kim, Caroline C, Kirkwood, John M, Lawson, David H, Leming, Philip D, Long, Georgina V, Marghoob, Ashfaq A, Mehnert, Janice M, Ming, Michael E, Nelson, Kelly C, Polsky, David, Scolyer, Richard A, Smith, Eric A, Sondak, Vernon K, Stark, Mitchell S, Stein, Jennifer A, Thompson, John A, Thompson, John F, Venna, Suraj S, Wei, Maria L, and Swetter, Susan M

Abstract

ImportanceUse of prognostic gene expression profile (GEP) testing in cutaneous melanoma (CM) is rising despite a lack of endorsement as standard of care.ObjectiveTo develop guidelines within the national Melanoma Prevention Working Group (MPWG) on integration of GEP testing into the management of patients with CM, including (1) review of published data using GEP tests, (2) definition of acceptable performance criteria, (3) current recommendations for use of GEP testing in clinical practice, and (4) considerations for future studies.Evidence reviewThe MPWG members and other international melanoma specialists participated in 2 online surveys and then convened a summit meeting. Published data and meeting abstracts from 2015 to 2019 were reviewed.FindingsThe MPWG members are optimistic about the future use of prognostic GEP testing to improve risk stratification and enhance clinical decision-making but acknowledge that current utility is limited by test performance in patients with stage I disease. Published studies of GEP testing have not evaluated results in the context of all relevant clinicopathologic factors or as predictors of regional nodal metastasis to replace sentinel lymph node biopsy (SLNB). The performance of GEP tests has generally been reported for small groups of patients representing particular tumor stages or in aggregate form, such that stage-specific performance cannot be ascertained, and without survival outcomes compared with data from the American Joint Committee on Cancer 8th edition melanoma staging system international database. There are significant challenges to performing clinical trials incorporating GEP testing with SLNB and adjuvant therapy. The MPWG members favor conducting retrospective studies that evaluate multiple GEP testing platforms on fully annotated archived samples before embarking on costly prospective studies and recommend avoiding routine use of GEP testing to direct patient management until prospective studies support their

Published
2020

36. Contributors

Author

Amin, Bijal, primary, Bergfeld, Wilma F., additional, Billings, Steven D., additional, Carlson, J. Andrew, additional, Celebi, Julide Tok, additional, Chen, Helen M., additional, Clarke, Loren E., additional, Prundeanu Croitoru, Anca G., additional, Fullen, Douglas R., additional, Fung, Maxwell A., additional, Goldblum, John R., additional, Granese, Jacqueline, additional, Haskell, Henry, additional, Junkins-Hopkins, Jacqueline M., additional, McNutt, Neil Scott, additional, Ming, Michael E., additional, Murali, Rajmohan, additional, Myskowski, Patricia L., additional, Nehal, Kishwer S., additional, Prieto, Victor G., additional, Pulitzer, Melissa, additional, Ramos-e-Silva, Marcia, additional, Rongioletti, Franco, additional, Scolyer, Richard A, additional, Sellheyer, Klaus, additional, Shea, Christopher R., additional, Thompson, John F., additional, Tudisco, Marie, additional, Ubriani, Ravi, additional, and Wyatt, Angela J., additional

Published
2010
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40. Urethral involvement is associated with higher mortality and local recurrence in vulvar melanoma: a single institutional experience

Author

Modi, Mitul B., primary, Gimotty, Phyllis A., additional, Ming, Michael E., additional, Jariwala, Neha, additional, Elenitsas, Rosalie, additional, Miller, Chris, additional, Chu, Emily Y., additional, Lindner, Hanna, additional, Moshiri, Ata S., additional, Schwartz, Lauren E., additional, Lal, Priti, additional, Reyes, Maria C., additional, Elder, David E., additional, and Xu, Xiaowei, additional

Published
2020
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47. Does MC1R genotype convey information about melanoma risk beyond risk phenotypes?

Author

Kanetsky, Peter A., Panossian, Saarene, Elder, David E., Guerry, DuPont, Ming, Michael E., Schuchter, Lynn, and Rebbeck, Timothy R.

Subjects
Melanoma -- Genetic aspects, Melanoma -- Risk factors, Melanoma -- Research, Intermedin -- Genetic aspects, Intermedin -- Physiological aspects, Intermedin -- Research, Genetic variation -- Research, Health
Published
2010

49. Chemoprevention agents for melanoma: A path forward into phase 3 clinical trials

Author

Jeter, Joanne, Bowles, Tawnya, Curiel-Lewandrowski, Clara, Swetter, Susan M., Filipp, Fabian V., Abdel-Malek, Zalfa, Geskin, Larisa J., Brewer, Jerry D., Arbiser, Jack L., Gershenwald, Jeffrey E., Chu, Emily Y., Kirkwood, John, Box, Neil F., Funchain, Pauline, Fisher, David E., Kendra, Kari, Marghoob, Ashfaq, Chen, Suephy C., Ming, Michael E., Albertini, Mark R., Vetto, John T., Margolin, Kim A., Pagoto, Sherry, Hay, Jennifer, Grossman, Douglas, Ellis, Darrel L., Kashani-Sabet, Mohammed, Mangold, Aaron R., Markovic, Svetomir, Meyskens, Frank L., Nelson, Kelly, Powers, Jennifer G., Robinson, June K., Sahni, Debjani, Sekulic, Aleksandar, Sondak, Vernon K., Wei, Maria L., Zager, Jonathan S., Dellavalle, Robert P., Thompson, John A., Weinstock, Martin A., Leachman, Sancy A., and Cassidy, Pamela B.

Subjects
Male, and promotion of well-being, Skin Neoplasms, natural products, Clinical Trials and Supportive Activities, Oncology and Carcinogenesis, Radiation-Protective Agents, Chemoprevention, Article, Drug Development, Clinical Research, melanoma, Animals, Humans, Anticarcinogenic Agents, Clinical Trials, Climate-Related Exposures and Conditions, Oncology & Carcinogenesis, 3.3 Nutrition and chemoprevention, Melanoma, Cancer, human model systems, Prevention, Drug Repositioning, biomarkers, Evaluation of treatments and therapeutic interventions, Prevention of disease and conditions, Phase III as Topic, Clinical Trials, Phase III as Topic, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, Public Health and Health Services, Female, Development of treatments and therapeutic interventions
Abstract

Recent progress in the treatment of advanced melanoma has led to unprecedented improvements in overall survival and, as these new melanoma treatments have been developed and deployed in the clinic, much has been learned about the natural history of the disease. Now is the time to apply that knowledge toward the design and clinical evaluation of new chemoprevention agents. Melanoma chemoprevention has the potential to reduce dramatically both the morbidity and the high costs associated with treating patients who have metastatic disease. In this work, scientific and clinical melanoma experts from the national Melanoma Prevention Working Group, composed of National Cancer Trials Network investigators, discuss research aimed at discovering and developing (or repurposing) drugs and natural products for the prevention of melanoma and propose an updated pipeline for translating the most promising agents into the clinic. The mechanism of action, preclinical data, epidemiological evidence, and results from available clinical trials are discussed for each class of compounds. Selected keratinocyte carcinoma chemoprevention studies also are considered, and a rationale for their inclusion is presented. These data are summarized in a table that lists the type and level of evidence available for each class of agents. Also included in the discussion is an assessment of additional research necessary and the likelihood that a given compound may be a suitable candidate for a phase 3 clinical trial within the next 5 years.

Published
2019

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