Faculty Bibliography

The revised version of the article corrected Figure 2. This change appears in the revised online PDF copy of this article.

The Pigmented Lesion Assay (PLA, sensitivity 91-95%, specificity 69-91%, negative predictive value ?99%) is a commercially available, non-invasive gene expression test that helps dermatologists guide pigmented lesion management decisions and rule out melanoma. Earlier studies have demonstrated high clinical utility and no missed melanomas in a 3-6-month follow-up period. We undertook the current investigations to provide 12-month follow-up data on PLA(-) tests, and to further confirm utility. A 12-month chart review follow-up of 734 pigmented lesions that had negative PLA results from 5 US dermatology centers was performed. Thirteen of these lesions (1.8%) were biopsied in the follow-up period and submitted for histopathologic review. None of the lesions biopsied had a histopathologic diagnosis of melanoma. The test's utility was studied further in a registry (N=1575, 40 US dermatology offices, 62 participating providers), which demonstrated that 99.9% of PLA(-) lesions were clinically monitored, thereby avoiding a surgical procedure, and 96.5% of all PLA(+) lesions were appropriately biopsied, most commonly with a tangential shave. This long-term follow-up study confirms the PLA's high negative predictive value and high utility in helping guide the management of pigmented lesions to avoid unnecessary surgical procedures.

Background/Objective: Accurate assessment of recurrence and metastatic risk is critical for cutaneous melanoma (CM) patient management decisions. Patients initially diagnosed with Stage I to II disease account for a large proportion of those who develop metastases and die from CM, suggesting a need for additional prognostic tools. The 31-Gene Expression Profile (GEP) test has been shown to stratify risk of developing metastasis within five years into low risk (Class 1; 1A lowest risk) and high risk (Class 2; 2B highest risk) and improves prognostic assessment for patients with melanoma. The test has been demonstrated to guide follow-up intensity, sentinel lymph node biopsy decisions, surveillance use, and possible adjuvant therapy. The current study evaluated performance of the 31-GEP test and its ability to improve accuracy of risk estimates over American Joint Committee on Cancer (AJCC) staging alone.
Method(s): Archival primary CM tumor samples from 18 centers in the United States (N=690, Stage I-III) along with clinicopathological and outcomes data were collected under an Institutional Review Board (IRB)-approved protocol. Stage I to II cases were restaged according to AJCC 8th edition. Class 1A and 2B-predicted melanoma-specific survival (MSS) outcomes for each stage were compared to rates associated with AJCC stage only. The Kaplan-Meier method and log-rank tests were used to assess five-year recurrence-free (RFS), distant metastasis-free survival (DMFS), and MSS rates.
Result(s): The 690-case cohort demonstrated stagespecific MSS rates matching those from the AJCC 8th edition cohort ('+/-1.2%). Class 2B cases had significantly worse RFS, DMFS, and MSS compared to Class 1A cases (p<0.0001). Across all stages, a 31-GEP result identified cases with improved (Class 1A) and worsened (Class 2B) prognoses compared to the risks predicted by clinicopathologic stage alone. Stage I patients have a five-year AJCC MSS rate of 98 percent, with the 690-case cohort rate at 98.5 percent. While Stage I Class 1A cases had a MSS rate of 99.6 percent (Stage IA equivalent), a Class 2B result was associated with a MSS rate between AJCC Stage IIA-IIB risk (MSS=89.5%). Stage II patients have a five-year AJCC MSS rate of 90 percent, with the 690-cohort rate at 90.7 percent. Among these cases, the MSS rate of Class 1A cases was greater than 99 percent (Stage IA equivalent), while for Class 2B cases, it was 84.7 percent (MSS between Stage IIB-IIC). Stage III patients have five-year MSS rates of 77 percent and 75.8 percent in the AJCC and 690-cohorts, respectively. Stage III Class 1A cases had an MSS rate of 94.8 percent (similar to Stage IIA), and Class 2B cases demonstrated a rate of 61.2 percent (worse than Stage IIIC).
Conclusion(s): This study demonstrates that 31-GEP testing adds prognostic value by further stratifying risk for melanoma-related mortality to improve risk estimates beyond AJCC staging alone

BACKGROUND:Insufficient understanding of sunscreen labeling terminology is a barrier to effective use. The FDA issued the "final rule" on sunscreen labeling in 2011, in an effort to promote effective usage. However, relatively little is known about patient knowledge of sunscreen labeling terminology. This study assesses the sunscreen labeling knowledge of dermatology patients, with an emphasis on understanding of the FDA-mandated wording. METHODS:A validated survey was administered to consecutive dermatology office patients. Respondents answered questions about sunscreen use practices, sunscreen knowledge, and demographics. To assess their sunscreen knowledge, they responded to questions on the concepts of sun protection factor, broad spectrum, and waterproof. RESULTS:334 patients completed surveys. Only 8.7% of patients correctly answered all 3 questions related to sunscreen labeling terminology. Patients with a personal history of skin cancer were more likely to answer more than half of the questions correctly (p=0.004). Older persons and those with darker skin types were most likely to answer all questions incorrectly. CONCLUSION/CONCLUSIONS:General understanding of sunscreen labeling was poor, and a minority of consumers comprehended the key features of sunscreen labeling. This knowledge gap appeared to be slightly smaller in the subpopulation of patients with a personal history of skin cancer.

Melanoma is rapidly evolving because of advances in noninvasive diagnosis, targeted therapies, and improved prognostic methods. This article discusses what is new in melanoma risk factors, prevention, clinical management, and targeted treatment. The incidence continues to increase worldwide, whereas mortality is steadily improving. This trend reinforces the importance of dermatologists comprehensively understanding all aspects of melanoma. Further research is needed to continue making a material impact on outcomes for patients.

Importance: The 31 gene-expression profiling test (31-GEP) has been shown to provide useful prognostic information in patients with cutaneous melanoma. The test dichotomizes patients into lower risk (Class 1) or higher risk (Class 2) for melanoma metastasis. Previous studies have demonstrated the clinical utility of the test in impacting dermatologists’ management decisions. Physician assistants and nurse practitioners (PA/NPs) account for a significant portion of dermatologic providers. The impact of a 31-GEP assay on clinical management has not been evaluated in this group.