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Non-Invasive Gene Expression Testing to Rule Out Melanoma

Rivers, J K; Copley, M R; Svoboda, R; Rigel, D S
The Pigmented Lesion Assay (PLA) is a gene expression test that helps rule out melanoma and has the potential to reduce the need for surgical biopsies of atypical pigmented skin lesions. Utilizing a new technological platform for the non-invasive profiling of skin, the assay analyzes samples collected from adhesive patches for expression of two key genes (PRAME and LINC00518) known to be overexpressed in melanoma. The test result is binary (positive/negative) based on the detection of one or both genes. PLA positive cases are generally biopsied to establish the histopathologic diagosis, while PLA negative cases are considered for ongoing monitoring. The combination of visual inspection with histopathology, the current gold standard for melanoma diagnosis, has a relatively low negative predictive value (NPV) of approximately 83%, meaning that 17% of melanomas will be interpreted as benign lesions. In contrast, the PLA has a very high NPV (>99%). Further, with its high specificity (69-91%), use of the PLA can reduce the number of false positive samples subjected to histopathology review. By adding the PLA to the current care pathway, the number of surgical biopsies needed to find a melanoma (number needed to biopsy) is markedly reduced from 20-25 biopsies for dermatologists and 39 biopsies for physician assistants, to an average of 2.7. To date, unnecessary surgical procedures of benign lesions have been reduced by 88% based on a sample of more than 20,000 analyzed cases. This has resulted in fewer missed melanomas and significant cost savings to health care systems.
PMID: 30248161
ISSN: 1201-5989
CID: 3334622

Skin Self-examination for Skin Cancer Prevention

Svoboda, Ryan M; Friedman, Robert J; Rigel, Darrell S
PMID: 30140870
ISSN: 1538-3598
CID: 3246222

Factors Affecting Dermatologists' Use of a 31-Gene Expression Profiling Test as an Adjunct for Predicting Metastatic Risk in Cutaneous Melanoma

Svoboda, Ryan M; Glazer, Alex M; Farberg, Aaron S; Rigel, Darrell S
IMPORTANCE/OBJECTIVE:A 31-gene expression profile (31-GEP) test to predict metastatic risk in patients with cutaneous malignant melanoma has previously been validated and is available for clinical use. The impact of the availability of such a test on clinical decision-making has previously been studied. However, little is known about which factors play a role in clinicians' decision to utilize the test. OBJECTIVE:To determine factors affecting clinicians' decisions to utilize the 31-GEP test for metastatic risk stratification in patients with cutaneous malignant melanoma. DESIGN, SETTING, AND PARTICIPANTS/METHODS:Dermatologists attending a national conference completed a series of questions based around four clinical vignettes using an audience response system. The vignettes and associated questions were designed to determine the impact of three factors-Breslow thickness, ulceration, and sentinel lymph node biopsy status-on the decision to order the 31-GEP test. Main Outcomes and Measures: The percentage of respondents who would order the 31-GEP test in the various clinical scenarios was quantified. Differences between groups were assessed using the chi-squared test. RESULTS:A total of 181/187 individuals completed the survey (96.8% response rate). For tumors with a Breslow thickness ≥0.5 mm, a majority of respondents reported that they would recommend the 31-GEP test. Ulceration was associated with a statistically significant increase in the percentage of clinicians who would recommend the assay for all but the thickest (2.1 mm) tumors. A negative SLN was only associated with a statistically significant increase in the percentage of clinicians who would recommend the test for the thinnest (0.26 mm) tumors (22% to 34%, P=0.033). CONCLUSIONS AND RELEVANCE/CONCLUSIONS:Ulceration appears to be the most important factor impacting clinicians when deciding to order the 31-GEP test to assess risk for melanoma metastasis. J Drugs Dermatol. 2018;17(5):544-547. <p>THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.</p>.
PMID: 29742186
ISSN: 1545-9616
CID: 3164112

Dermatologist Practices During Total Body Skin Examinations: A Survey Study

Rieder, Evan A; Mu, Euphemia W; Wang, Jenny; Cohen, David E; Rigel, Darrell S; Stevenson, Mary L
Though screening for skin cancer is an essential practice in dermatology, limited data are published on dermatologists' total body skin examination (TBSE) behaviors. We surveyed 6500 dermatologists on their TBSE practices, including questions about less commonly examined body sites. We found varied TBSE practices among all dermatologists and discrepancies in examinations between dermatologists of opposite genders. J Drugs Dermatol. 2018;17(5):516-520.
PMID: 29742182
ISSN: 1545-9616
CID: 3164102

Enhanced melanoma diagnosis with multispectral digital skin lesion analysis

Farberg, Aaron S; Glazer, Alex M; Winkelmann, Richard R; Tucker, Natalie; White, Richard; Rigel, Darrell S
Multispectral digital skin lesion analysis (MSDSLA) is both sensitive and specific in the detection of malignant melanoma by dermatologists and nondermatologists, and data have shown that MSDSLA can be a valuable tool in the evaluation of pigmented skin lesions (PSLs). This study aimed to aggregate data from 7 prior studies to provide a comprehensive overview and evaluate the consistency of the effects of MSDSLA when used in conjunction with clinical examination and dermoscopy to evaluate PSLs.
PMID: 29894523
ISSN: 2326-6929
CID: 3147972

Melanoma Reporting Practices of United States Dermatologists

Svoboda, Ryan M; Glazer, Alex M; Farberg, Aaron S; Cowdrey, Molly C E; Rigel, Darrell S
BACKGROUND:Accuracy of US cancer statistics depends on physicians' knowledge of and adherence to reporting mandates. Significant knowledge and practice gaps have been documented in regards to melanoma reporting requirements. OBJECTIVE:To determine whether the gaps in dermatologists' knowledge and practice of melanoma reporting persist. MATERIALS AND METHODS/METHODS:The authors performed a survey of US dermatologists attending a national conference. The proportion aware of the melanoma reporting mandate and the proportion who routinely report newly diagnosed cases were calculated. RESULTS:Ninety-one percent (158/174) of those sampled completed the survey. Forty-nine percent correctly identified melanoma as being a disease of mandated reporting. Only 34% reported newly diagnosed cases to their state registry. Dermatologists seeing low melanoma volumes were less likely to routinely report newly diagnosed cases to registries than those seeing high volumes (22.9% vs 45.4%, p = .004). Those in practice for ≤10 years were less likely to be aware of the mandate than those in practice longer (32.6% vs 57.0%, p = .006). CONCLUSION/CONCLUSIONS:Most of the dermatologists remain unaware of melanoma reporting requirements. Resultant underestimates of the true incidence of melanoma could have resource allocation implications. Interventions aimed at improving knowledge of the mandate should focus on younger clinicians and those with lower melanoma case volumes.
PMID: 29847335
ISSN: 1524-4725
CID: 3136952

Evaluating Industry Payments Among Dermatology Clinical Practice Guideline Authors

Glazer, Alex M; Siegel, Daniel M; Rigel, Darrell S
PMID: 29417133
ISSN: 2168-6084
CID: 2948202

Realistic Sunscreen Durability: A Randomized, Double-blinded, Controlled Clinical Study

Ouyang, Hao; Meyer, Karen; Maitra, Prithwiraj; Daly, Susan; Svoboda, Ryan M; Farberg, Aaron S; Rigel, Darrell S
BACKGROUND:Studies show that sunscreen under real-life conditions is often not reapplied and/or applied insufficiently. This study investigated the durability of 2 current sunscreens with different SPF protection over an 8-hour period under simulated real-life conditions. METHODS:Participants (n=24) were randomized into two study groups utilizing either 2 mg/cm2 (FDA testing concentration) or 1 mg/cm2 (real-life application levels) of sunscreen. Two current SPF 15 and 70 sunscreens were applied to test spots on each participant's back. SPF values were obtained at baseline, 3.5, and 8 hours after initial application, during which subjects completed 30 minutes of moderate exercise followed by 80 minutes of water exposure. RESULTS:Participants in both dose study groups revealed only a 15-40% overall decrease in their SPF protection 8 hours after application. The study group that received half the FDA test concentration of sunscreen achieved approximately half or less the labeled SPF. At 8 hours, the test sites that received SPF 70 maintained an average SPF greater than 64 (2 mg/cm2 application) and 26 (1 mg/cm2 application). Similarly, the SPF 15 product test sites revealed an in vivo protection of 13 (2 mg/cm2) and 7 (1 mg/cm2). CONCLUSION/CONCLUSIONS:This study demonstrates that current sunscreens may be durable on skin even following significant exercise and water exposure, suggesting that reapplication intervals may be longer than currently recommended. In addition, the higher SPF sunscreen maintained a skin cancer-protective level of SPF following extended use. <p><em>J Drugs Dermatol. 2018;17(1):116-117.</em></p>.
PMID: 29320597
ISSN: 1545-9616
CID: 2926182

SPF 100+ sunscreen is more protective against sunburn than SPF 50+ in actual-use: Results of a randomized, double-blind, split-face, natural sunlight exposure, clinical trial

Williams, Joshua D; Maitra, Prithwiraj; Atillasoy, Evren; Wu, Mei-Miau; Farberg, Aaron S; Rigel, Darrell S
BACKGROUND:The value of additional photoprotection provided by use of high SPF sunscreens is controversial and limited clinical evidence exists. OBJECTIVE:To compare the sunburn protection provided by SPF100+ and SPF50+ sunscreen in conditions of actual use. METHODS:199 healthy men and women (≥18 years) participated in a natural sunlight, single exposure, split face, randomized, double blind study in Vail, Colorado. Each participant wore both sunscreens simultaneously during activities with no usage restrictions other than treatment area designation. Erythema was clinically assessed the day following exposure. Comparative efficacy was evaluated through bilateral comparison of sunburn between treatment areas and erythema score as evaluated separately for each treatment area. RESULTS:Following an average 6.1 ± 1.3 hours of sun exposure, investigator blinded evaluation identified 55.3% (110/199) of the participants as more sunburned on the SPF50+ and 5% (10/199) on the SPF100+ protected side. Post exposure, 40.7% (81/199) of the participants exhibited increased erythema scores ≥ 1 on the SPF50+ protected side as compared to 13.6% (27/199) on the SPF100+. LIMITATIONS/CONCLUSIONS:Single day exposure may not extrapolate to benefits of longer-term protection. CONCLUSION/CONCLUSIONS:SPF100+ sunscreen was significantly more effective in protecting against sunburn than SPF50+ sunscreen in actual-use conditions. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov(NCT02952235).
PMID: 29291958
ISSN: 1097-6787
CID: 2899642

Trends in US sunscreen formulations: Impact of increasing spray usage

Teplitz, Rebeca W; Glazer, Alex M; Svoboda, Ryan M; Rigel, Darrell S
PMID: 29241780
ISSN: 1097-6787
CID: 2837192