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2.
Curr Med Res Opin ; : 1-6, 2020 May 18.
Artigo em Inglês | MEDLINE | ID: mdl-32372702

RESUMO

Objective: To determine how results from a prognostic 40-gene expression profiling (40-GEP) test would impact clinician management decisions and how their choices would align with a National Comprehensive Cancer Network (NCCN) compliant, risk-directed management plan for high-risk cutaneous squamous cell carcinoma (cSCC).Methods: Clinicians attending a national dermatology conference were presented with 40-GEP test validation data. They were asked to rate clinicopathological features and molecular test results to assess their opinion of how concerning each is to cSCC prognosis. When presented with vignettes describing patients with NCCN-defined high-risk features, clinicians were asked to select a treatment plan using pre-test (no 40-GEP results), then, post-test (40-GEP Class 1, 2A, or 2B results) methodology along with corresponding metastasis rates for each test group.Results: Risk factors deemed of highest concern for metastatic outcomes were a Class 2B 40-GEP result, perineural invasion, immunosuppression, invasion beyond subcutaneous fat, and tumor diameter >1 cm on the scalp. When presented with a 40-GEP result that indicated reduced risk of metastasis (Class 1), clinicians altered their treatment management plan accordingly. Specifically, there was significant reduction in the recommendations for sentinel lymph node biopsy, adjuvant radiation or chemotherapy, follow-up time, and nodal imaging. By comparison, when a 40-GEP result indicated an increased risk of metastasis (Class 2B), significant risk-appropriate increases in management intensity was observed for the aforementioned clinical decisions.Conclusion: Integration of 40-GEP results impacted management decisions in a significant and risk-appropriate manner for high-risk cSCC patient scenarios, while remaining aligned with national guidelines for patient management.

3.
J Am Acad Dermatol ; 2020 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-32344066

RESUMO

BACKGROUND: Current staging systems for cutaneous squamous cell carcinoma (cSCC) have limited positive predictive value (PPV) for identifying patients who will experience metastasis. OBJECTIVE: To develop and validate a gene expression profile (GEP) test for predicting risk for metastasis in localized, high-risk cSCC with the goal of improving risk-directed patient management. METHODS: Archival formalin-fixed paraffin-embedded primary cSCC tissue and clinicopathologic data (n=586) were collected from 23 independent centers in a prospectively designed study. A GEP signature was developed using a discovery cohort (n=202) and validated in a separate, non-overlaping, independent cohort (n=324). RESULTS: A prognostic, 40-gene expression profile (40-GEP) test was developed and validated, stratifying high-risk cSCC patients into classes based on metastasis risk: Class 1 (low-risk), Class 2A (high-risk), and Class 2B (highest-risk). For the validation cohort, 3-year metastasis-free survival (MFS) rates were 91.4%, 80.6%, and 44.0%, respectively. A PPV of 60% was achieved for the highest-risk group (Class 2B), an improvement over staging systems; while negative predictive value, sensitivity, and specificity were comparable to staging systems. LIMITATIONS: Potential understaging of cases could affect metastasis rate accuracy. CONCLUSION: The 40-GEP test is an independent predictor of metastatic risk that can complement current staging systems for patients with high-risk cSCC.

4.
J Drugs Dermatol ; 18(10): 980-984, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31584775

RESUMO

Background: The incidence of cutaneous squamous cell carcinoma (cSCC) is increasing likely due to improved detection and a growing elderly population. Although the prognosis of cSCC is excellent with complete surgical excision, many patients who go on to develop metastasis are initially classified as low-risk. The most commonly used staging systems, American Joint Committee on Cancer (AJCC) and Brigham Women's Hospital (BWH), have low sensitivity and low positive predictive value for predicting metastasis. A gene expression profile test (cSCC-GEP) is in development to identify patients with cSCC at high risk for metastasis and death. Objective: To determine the impact of cSCC-GEP test results on management decisions made by dermatologists for cSCC patients. Design, Setting, and Participants: 402 dermatologists attending a national dermatology conference completed an online survey designed to determine the impact of cSCC-GEP test results on management decisions in a variety of clinical situations. Participants answered a series of questions related to three cSCC patient vignettes, each featuring different patient and lesion characteristics. Main Outcomes and Measures: Proportion of dermatologists who would recommend radiation, chemotherapy/immunotherapy, or sentinel lymph node biopsy (SLNBx) for each patient vignette (without cSCC-GEP results, with a lower risk result, or with a higher risk result). The effect of the test results on the follow-up intervals recommended by dermatologists was also examined. Results: In the majority of vignettes, a lower risk cSCC-GEP test result led to a statistically significant decrease in the proportion of dermatologists who would recommend radiation, chemotherapy/immunotherapy, SLNBx, or quarterly follow-up. Conversely, a higher risk cSCC-GEP result significantly altered management toward increased intensity (more recommendations for radiation, chemotherapy/immunotherapy, SLNBx, or quarterly follow-up) in all vignettes. Conclusions and Relevance: The results of a cSCC-GEP test appear to significantly impact decisions made by dermatologists regarding subsequent management, SLNBx, and follow-up intervals for patients with cSCC. J Drugs Dermatol. 2019;18(10):980-984.


Assuntos
Carcinoma de Células Escamosas/terapia , Tomada de Decisão Clínica/métodos , Dermatologia/métodos , Perfilação da Expressão Gênica , Neoplasias Cutâneas/terapia , Adulto , Assistência ao Convalescente/métodos , Idoso , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/patologia , Dermatologistas/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Prognóstico , Medição de Risco/métodos , Neoplasias Cutâneas/diagnóstico , Neoplasias Cutâneas/patologia , Inquéritos e Questionários/estatística & dados numéricos
6.
Dermatol Online J ; 25(5)2019 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-31220892

RESUMO

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.


Assuntos
Melanoma/diagnóstico , Nevo Pigmentado/diagnóstico , Neoplasias Cutâneas/diagnóstico , Biópsia/estatística & dados numéricos , Diagnóstico Diferencial , Feminino , Seguimentos , Perfilação da Expressão Gênica , Testes Genéticos/métodos , Humanos , Masculino , Melanoma/genética , Melanoma/patologia , Pessoa de Meia-Idade , Padrões de Prática Médica/estatística & dados numéricos , Valor Preditivo dos Testes , Sistema de Registros , Sensibilidade e Especificidade , Neoplasias Cutâneas/genética , Neoplasias Cutâneas/patologia , Estados Unidos
7.
Photodermatol Photoimmunol Photomed ; 35(5): 339-343, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31095785

RESUMO

BACKGROUND: Sunscreens, unlike prescription medications, are purchased by consumers directly from retailers. The proportion of online sunscreen sales is increasing. It is therefore important for dermatologists to know what factors influence online sunscreen purchases to optimize appropriate recommendations. METHODS: Data on the top 100 best-selling sunscreens from an online retailer were collected. Variables included cost, formulation, product claims, ingredients, consumer ratings, and number of reviews. Ordinal logistic regression was used to analyze the impact of collected variables on position on the best-seller list. RESULTS: Ninety-six of the 100 search results could be defined as actual sunscreens with a total of 41 788 reviews. The median price per ounce was $3.02 (range $0.34-$309.18). The most popular formulations were lotions. The most common unregulated claim was "non-greasy" found in 57.3% of sunscreens. For 26 unregulated product claims analyzed, the mean number of claims per sunscreen was 5.2. Using an ordinal regression model, the following factors were found to significantly influence sunscreen sales: number of reviews, the claim "decreases the risk of skin cancer and early aging," and the presence of six or more unregulated claims. CONCLUSIONS: Multiple sunscreen options exist for consumers with varying price points, active ingredients, and formulations. Consumers who purchase online prefer sunscreens with a higher number of reviews and more unregulated marketing claims. FDA-regulated claims such as "decreases the risk of skin cancer and early aging" are not as impactful in this purchasing cohort. To facilitate usage, dermatologists should be cognizant of factors that influence sunscreen selection among this group.


Assuntos
Comportamento do Consumidor , Marketing , Envelhecimento da Pele , Neoplasias Cutâneas/prevenção & controle , Protetores Solares/administração & dosagem , Humanos
8.
Dermatol Clin ; 37(2): 159-168, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30850038

RESUMO

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.


Assuntos
Antineoplásicos Imunológicos/uso terapêutico , Procedimentos Cirúrgicos Dermatológicos , Melanoma/terapia , Anti-Inflamatórios não Esteroides/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Biópsia , Café , Espectroscopia Dielétrica , Detecção Precoce de Câncer , Predisposição Genética para Doença , Genômica , Humanos , Doenças Inflamatórias Intestinais/epidemiologia , Ipilimumab/uso terapêutico , Melanoma/diagnóstico , Melanoma/epidemiologia , Melanoma/genética , Microscopia Confocal , Nivolumabe/uso terapêutico , Inibidores da Fosfodiesterase 5/uso terapêutico , Prevenção Primária , Prognóstico , Fatores de Proteção , Fatores de Risco , Prevenção Secundária , Biópsia de Linfonodo Sentinela , Fator de Proteção Solar , Protetores Solares/uso terapêutico , Ultrassonografia , Vemurafenib/uso terapêutico
10.
Photodermatol Photoimmunol Photomed ; 35(3): 141-147, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30383894

RESUMO

BACKGROUND: Insufficient understanding of sunscreen labeling terminology is a barrier to effective use. The Food and Drug Administration (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: A total of 334 patients completed surveys. Only 8.7% of patients correctly answered all three 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: 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.


Assuntos
Rotulagem de Medicamentos , Conhecimento do Paciente sobre a Medicação , Protetores Solares , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Terminologia como Assunto , Estados Unidos , United States Food and Drug Administration
12.
Cutis ; 101(5): 338-340, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29894523

RESUMO

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.


Assuntos
Dermoscopia/normas , Melanoma/diagnóstico , Neoplasias Cutâneas/diagnóstico , Humanos , Sensibilidade e Especificidade
13.
Dermatol Surg ; 44(11): 1391-1395, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29847335

RESUMO

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.


Assuntos
Dermatologistas , Melanoma/epidemiologia , Padrões de Prática Médica/estatística & dados numéricos , Neoplasias Cutâneas/epidemiologia , Métodos Epidemiológicos , Humanos , Inquéritos e Questionários , Estados Unidos/epidemiologia
14.
J Drugs Dermatol ; 17(5): 516-520, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29742182

RESUMO

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.


Assuntos
Dermatologistas , Exame Físico , Padrões de Prática Médica , Neoplasias Cutâneas/prevenção & controle , Feminino , Humanos , Masculino , Inquéritos e Questionários , Estados Unidos
15.
J Drugs Dermatol ; 17(5): 544-547, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29742186

RESUMO

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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Assuntos
Técnicas de Apoio para a Decisão , Perfilação da Expressão Gênica/estatística & dados numéricos , Melanoma/diagnóstico , Padrões de Prática Médica , Neoplasias Cutâneas/diagnóstico , Adulto , Idoso , Dermatologistas , Feminino , Humanos , Masculino , Melanoma/genética , Melanoma/patologia , Pessoa de Meia-Idade , Metástase Neoplásica , Valor Preditivo dos Testes , Neoplasias Cutâneas/genética , Neoplasias Cutâneas/patologia , Estados Unidos
17.
J Am Acad Dermatol ; 78(5): 902-910.e2, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29291958

RESUMO

BACKGROUND: The value of additional photoprotection provided by use of high-sun protection factor (SPF) sunscreens is controversial, and limited clinical evidence exists. OBJECTIVE: To compare the sunburn protection provided by SPF 100+ and SPF 50+ sunscreen in conditions of actual use. METHODS: A total of 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 use restrictions other than designation of the treatment area. Erythema was clinically assessed on 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% of the participants (110 of 199) as more sunburned on the SPF 50+ protected side and 5% (10 of 199) on the SPF 100+ protected side. After exposure, 40.7% of the participants (81 of 199) exhibited increased erythema scores (by ≥1) on the SPF 50+ protected side as compared with 13.6% (27 of 199) on the SPF 100+ protected side. LIMITATIONS: Single-day exposure may not extrapolate to benefits of longer-term protection. CONCLUSION: SPF 100+ sunscreen was significantly more effective in protecting against sunburn than SPF 50+ sunscreen in actual use conditions.


Assuntos
Fator de Proteção Solar/métodos , Queimadura Solar/prevenção & controle , Protetores Solares/química , Protetores Solares/uso terapêutico , Raios Ultravioleta/efeitos adversos , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Estudos Prospectivos , Medição de Risco , Sensibilidade e Especificidade , Fatores de Tempo , Resultado do Tratamento
18.
J Drugs Dermatol ; 17(1): 116-117, 2018 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-29320597

RESUMO

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: 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.

J Drugs Dermatol. 2018;17(1):116-117.

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Assuntos
Fator de Proteção Solar , Protetores Solares/farmacocinética , Banhos , Método Duplo-Cego , Exercício Físico , Humanos , Protetores Solares/administração & dosagem , Fatores de Tempo , Água
20.
Dermatol Clin ; 35(4): 409-416, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28886797

RESUMO

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.


Assuntos
Promoção da Saúde , Melanoma/diagnóstico , Autoexame , Neoplasias Cutâneas/diagnóstico , Detecção Precoce de Câncer , Humanos
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