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Improvement of risk assessment in cutaneous melanoma (CM) by a prognostic 31-gene expression profile (31-GEP) test over AJCCbased staging alone [Meeting Abstract]

Prado, G; Cook, R W; Covington, K R; Monzon, F A; Rigel, D
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
EMBASE:629676608
ISSN: 1941-2789
CID: 4168482

What's New in Melanoma

Prado, Giselle; Svoboda, Ryan M; Rigel, Darrell S
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.
PMID: 30850038
ISSN: 1558-0520
CID: 3724262

Assessment of Clinician Accuracy for Diagnosing Melanoma Based on Electrical Impedance Spectroscopy Score Plus Morphology Versus Lesion Morphology Alone

Svoboda, Ryan M; Prado, Giselle; Mirsky, Rachel S; Rigel, Darrell S
PMID: 30227189
ISSN: 1097-6787
CID: 3300532

Improved risk assessment through incorporation of a prognostic 31-gene expression profile test for AJCC stage IB-IIA cutaneous melanoma [Meeting Abstract]

Prado, Giselle; Kurley, Sarah J.; Covington, Kyle R.; Cook, Robert W.; Monzon, Federico A.; Rigel, Darrell
ISI:000482195002094
ISSN: 0190-9622
CID: 4086122

The Low Prevalence of Allergic Contact Dermatitis Using a Petrolatum Ointment Containing Lanolin Alcohol

Draelos, Zoe Diana; Kircik, Leon H.; Rigel, Darrell
ISI:000488330900004
ISSN: 1545-9616
CID: 4135862

Analysis of best selling sunscreens: Consumer preferences, product characteristics, and active ingredients [Meeting Abstract]

Prado, Giselle; Ederle, Ashley; Shahriari, Shawhin; Svoboda, Ryan; Farberg, Aaron; Rigel, Darrell
ISI:000482195000068
ISSN: 0190-9622
CID: 4086012

Management Decisions Made by Physician Assistants and Nurse Practitioners in Cutaneous Malignant Melanoma Patients: Impact of a 31-Gene Expression Profile Test

Mirsky, Rachel; Prado, Giselle; Svoboda, Ryan; Glazer, Alex; Rigel, Darrell
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.
PMID: 30500144
ISSN: 1545-9616
CID: 3659202

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

Using a novel topical adhesive as an alternative to superficial sutures for wound closure following dermatologic excisional procedures: A case series [Meeting Abstract]

Svoboda, R; Zuckerman, J; Rigel, D
Background: The topical adhesive 2-octyl cyanoacrylate has been used as an alternative to sutures for closure of skin in a variety of surgical procedures. While there have been benefits in terms of ease of application and cosmetic result, a high incidence of allergic contact dermatitis and exothermic reactions has been a barrier to use. Objectives. To investigate the feasibility of using a novel formulation of 2-octyl cyanoacrylate (Actabond-Bergen Medical Products, Morris Plains, New Jersey) for skin closure after surgical excision of cutaneous lesions.
Method(s): We examined the results of office-based surgical excision procedures using a novel formulation of 2-octyl cyanoacrylate for skin closure. Photographs were taken preoperatively, intraoperatively (open wound, before adhesive application, following adhesive application), and 2 weeks after surgery. At follow-up, all incisions were examined for cosmetic result, skin edge separation, erythema, and abscess formation. Patient satisfaction was also assessed.
Result(s): Ten lesions in 9 consecutive patients undergoing cutaneous excision by two surgeons were included in the study. The average age of included patients was 42. Lesions were excised from the trunk (6) and extremities (4). Lesion types included 3 dysplastic nevi, 3 sebaceous cysts, 3 lipomas, and 1 squamous cell carcinoma. At 2-week follow-up, all wounds were healed without any signs of dehiscence or infection. All wounds demonstrated esthetic closure without suture tracts. None of the patients developed allergic contact dermatitis or burns. On a 1-10 scale, respondents' average satisfaction with the method was 7.7. For patients who had previous skin suture closures, 83% preferred adhesive. Conclusion and relevance. A novel formulation of 2-octyl cyanoacrylate topical adhesive demonstrated feasibility as a potential alternative to the use of sutures for skin closure. In this small case series, all patients had an excellent esthetic result with no complications. Compared with previous iterations of 2-octyl cyanoacrylate, there were no allergic or exothermic reactions in this pilot series. Larger studies need to be performed to further determine advantages that may exist using this closure method compared with standard techniques.
Copyright
EMBASE:2000994678
ISSN: 0190-9622
CID: 4385162

Clinical and economic implications of a noninvasive molecular pathology assay for early detection of melanoma [Meeting Abstract]

Hornberger, J; Rigel, D
Background: More than 90% of ~2.5 million surgical biopsies performed to rule out melanoma in the U.S. alone are benign and classified as neither invasive melanomas nor melanomas in situ by histopathology. A recently described adhesive patch skin biopsy based noninvasive gene expression test (pigmented lesion assay; PLA) demonstrated utility and differentiated benign from malignant pigmented skin lesions with a test performance that exceeded visual inspection (VI) and a sensitivity that matching the criterion standard of dermatopathology. However, cost and outcome implications of using this molecular test versus VI have not been evaluated.
Objective(s): To determine potential cost savings and impact on outcome of PLA use versus VI in patients with pigmented cutaneous lesions suggestive of melanoma. Design and setting: Health economic analyses were performed from average U.S. insurance reimbursement values, comparing the real-world impact of the PLA with VI. Data sources were from published clinical validation and utility studies as well as from routine use of the test in U.S. dermatology practices, augmented by fee schedules of CMS.
Result(s): The biopsy ratio declined from 12.5 for VI to 2.4 for PLA use; correspondingly, the number needed to excise (NNE) declined from 2.85 for VI to 1.37 for PLA use. The 1.77-fold increase in specificity of PLA over VI also resulted in lower costs for initial biopsy ($211), subsequent excisions ($86), surveillance management ($77), and management of melanoma ($508). There was $31 average savings from avoidance of lost work productivity, and improvement in patient experience as assessed by quality adjusted life years (gain of 0.016 years). Conclusions and relevance: The higher accuracy of PLA use versus VI resulted in fewer unnecessary procedures and office visits, while not compromising early melanoma detection. The consequence effects are potentially reduced direct medical costs, reduced work productivity loss, and improved patient experience and care.
Copyright
EMBASE:2000994870
ISSN: 0190-9622
CID: 4385142