The Integrated i31-GEP Test Outperforms the MSKCC Nomogram at Predicting SLN Status in Melanoma Patients.

BACKGROUND/AIM: Sentinel lymph node biopsy (SLNB) for patients with cutaneous melanoma is primarily a prognostic procedure that broadly identifies patients who may have disease progression and may warrant additional intervention. However, 88% of patients undergoing SLNB receive a negative result and of those, some will succumb to their disease. One clinical utility of the integrated 31-GEP test, which combines gene expression data with clinicopathologic factors to provide a personalized, precise risk of SLN positivity, is SLNB guidance. This study compared the i31-GEP for SLNB to a nomogram that predicts SLN positivity using only clinicopathologic factors. PATIENTS AND METHODS: Patients with T1-T2 tumors and known SLN status (N=465) were analyzed by the i31-GEP for SLNB and a nomogram developed at Memorial Sloan Kettering Cancer Center (MSKCC). A 5% risk threshold was used to conform with national guidelines. RESULTS: In patients with <5% predicted risk, SLN positivity was 2.7% (3/111) for i31-GEP versus 10.0% (11/110, p=0.026) for MSKCC. In each T-category, the i31-GEP maintained a false-negative rate below the 5% risk threshold in those predicted to have a <5% risk, while the MSKCC nomogram did not. CONCLUSION: Integrating the 31-GEP with traditional factors outperformed a nomogram that uses clinicopathologic factors alone to predict SLN status. Incorporating the i31-GEP into clinical practice could improve identification of patients for SLNB, resulting in better risk-aligned management.

Enhanced melanoma diagnosis with multispectral digital skin lesion analysis.

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.

Melanoma Reporting Practices of United States Dermatologists.

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: 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: Most 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.

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

IMPORTANCE: 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: 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: 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.

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Clinical Diagnosis of Skin Cancer: Enhancing Inspection and Early Recognition.

The annual incidence rate for melanoma and nonmelanoma skin cancer continues to rise and morbidity and deaths from skin cancer are increasing. Despite advances in therapeutics, the factors that most impact prognosis remain early recognition and removal of neoplasms before deep invasion or metastatic disease can occur. There are numerous public health and screening initiatives that have been introduced to help recognize disease earlier and to increase patients' awareness of signs or changes of lesions that may represent skin cancers. Early recognition and removal of suspicious lesions remains critical in significantly reducing morbidity and mortality associated with skin cancers.

Noninvasive Technologies for the Diagnosis of Cutaneous Melanoma.

Multispectral analysis devices assess pigmented lesion disorganization at different levels using variable wavelengths of light. Computerized algorithms measure morphologic disorganization of the pigmented skin lesion. Aggregated data of 855 participants investigating the influence of multispectral digital skin lesion analysis (MSDSLA) on practitioner decisions to biopsy pigmented skin lesions revealed the overall sensitivity for detection of melanoma improved from 70% to 88%. Participant specificity increased from 52% to 58% after MSDSLA. Five studies using spectrophotometric intracutaneous analysis scope to evaluate suspicious pigmented skin lesions demonstrated an overall sensitivity and specificity of 85% and 81%, respectively, for the detection of melanoma.

Assessing Genetic Expression Profiles in Melanoma Prognosis.

A 31-genetic expression profile (31-GEP) test (DecisionDx-Melanoma, Castle Biosciences Inc, Friendswood, TX, USA) was developed as a diagnostic test to assist physicians in the management of cutaneous malignant melanoma. Based on a patient's primary tumor expression levels of a panel of genes (28 discriminating genes and 3 control genes), a lesion is classified as "low risk" (class 1) or "high risk" (class 2) for metastasis. Studies evaluating the clinical utility and impact of the 31-GEP test showed it positively influenced clinical management and patient care, as clinicians incorporated the additional data to modify their clinical recommendations in a risk-appropriate manner.

Integrating Skin Cancer-Related Technologies into Clinical Practice.

Early diagnosis and treatment of melanoma improve survival. New technologies are emerging that may augment the diagnosis, assessment, and management of melanoma but penetrance into everyday practice is low. In the current health care climate, greater emphasis will be placed on the incorporation of technology for clinically suspicious pigmented lesions to facilitate better, more cost-effective management.

Impact of a 31-gene Expression Profiling Test for Cutaneous Melanoma on Dermatologists' Clinical Management Decisions.

Importance: Current guidelines for cutaneous malignant melanoma (CMM) provide general recommendations regarding surveillance while indicating that management should be tailored to patients' individual probability of recurrence. A 31-gene expression profile (31-GEP) test to predict metastatic risk has been previously validated, and classifies patients as either Class 1 (low risk) or Class 2 (high risk).

Objective: To determine the impact of the 31-GEP test's result on clinical decision-making.

Design, Setting, and Participants: Dermatology residents who attended a national educational conference were presented with clinical validity evidence for the 31-GEP. Respondents were given six CMM patient vignettes with descriptions of clinical features and answered questions about their willingness to recommend sentinel lymph node biopsy (SLNBx) or imaging based on each scenario. Additionally, respondents were asked to provide the Breslow thickness (BT), ranging from 0.7-1.5mm in 0.1mm increments, at which they would recommend SLNBx, imaging, or oncology referral.

Main Outcomes and Measures: The number of respondents who would recommend each management modality based upon three outcomes (no result, Class 1, or Class 2) was quantified. Differences between response groups were assessed using Fisher's exact test.

Results: The majority of respondents (62%, 57%, and 55%, respectively) indicated a 1.0mm BT as the guiding modality, reflecting adherence to current guidelines. After inclusion of a Class 2 result, the BT used to guide SLNBx, oncology referral, and imaging was changed in 47%, 50% and 47% of the responses, respectively, with 95%, 84% and 97% of the cases, respectively, changed in a risk-appropriate direction (decreased BT). Based on a 31-GEP Class 1 or Class 2 result, risk appropriate recommendations were more likely to be made for each management modality tested in five of the six patient vignettes (P less than 0.05).

Conclusions and Relevance: The 31-GEP test had a significant and appropriate impact on management while remaining within the context of established guidelines.

J Drugs Dermatol. 2017;16(5):428-431.

Successful Treatment of Generalized Essential Telangiectasia With 6-Mercaptopurine.

Generalized essential telangiectasia (GET) is a notoriously difficult to treat disorder with no current satisfactory treatments. This case and discussion report the use of 6-mercaptopurine (6-MP) as a successful treatment for GET. Moreover, we show that GET may represent a state of increased angiogenesis, a paradigm shift from the current understanding that these telangiectasias represent dilatations of only pre-existing vessels. This new view of GET may drive others to look at novel agents for treatment.

J Drugs Dermatol. 2017;16(3):280-282.

Quantitative ABCD parameters measured by a multispectral digital skin lesion analysis device for evaluation of suspicious pigmented skin lesions strongly correlate with clinical ABCD observations.

Background/Study Aim: A multispectral digital skin lesion analysis (MSDSLA) device has proven to be sensitive and specific for malignant melanoma (MM) detection by dermatologists and may have other useful applications. This study aimed to develop and test objective quantitative Asymmetry, Border irregularity, Color, and Diameter (qABCD) parameters for MSDSLA and correlate them with the presence of clinical ABCD features to aid the decision to biopsy a suspicious pigmented skin lesions (PSLs). METHODS: 1632 benign and malignant [175 MM/High Grade Dysplastic Nevi (HGDN)] were evaluated for their qABCD parameters. Quantitative characteristics were correlated with the presence of clinical ABCD features identified by independent dermatologists. RESULTS: qA, qB, qC, and qD had correlations of 78%, 73%, 76%, and 86%, respectively, for non-MM/HGDN lesions. The correlations for qA, qB, qC, and qD for MM/HGDN lesions was 86.3%, 83%, 89%, and 89%, respectively. All repeatability parameters were statistically significant. CONCLUSIONS: This study demonstrates qABCD values are repeatable and strongly correlate with the clinical ABCD features. qABCD characteristics provide an additional objective and reliable means of identifying PSLs that need further evaluation to rule out MM and, in combination with the clinical ABCDs, may allow for improved assessment when evaluating the malignant potential of PSLs.