Use of a prognostic gene expression profile test for T1 cutaneous melanoma: Will it help or harm patients?  Michael A. Marchetti, MD, Edmund K. Bartlett,

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Use of a prognostic gene expression profile test for T1 cutaneous melanoma: Will it help or harm patients?  Michael A. Marchetti, MD, Edmund K. Bartlett, MD, Stephen W. Dusza, DrPH, Christopher K. Bichakjian, MD  Journal of the American Academy of Dermatology  Volume 80, Issue 6, Pages e161-e162 (June 2019) DOI: 10.1016/j.jaad.2018.11.063 Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Estimate of the clinical performance of the 31-gene expression profile test with 100 hypothetical patients with T1 (thickness, ≤1 mm) cutaneous melanoma and a 5-year distant metastasis–free survival rate of 95%. *These data assume a 5-year distant metastasis–free survival rate of 95% and 31-gene expression profile test sensitivity and specificity of approximately 20% and approximately 90%, respectively.1 Therefore, there would be 10 class 2 results (9 false positives and 1 true positive) and 90 class 1 results (4 false negatives and 86 true negatives). †As the baseline risk of distant metastasis is approximately 95% and the class 1 risk of distant metastasis is approximately 96%, the negative predictive value of the test is unlikely to benefit patients or alter physician-directed surveillance. Comparable analyses were performed for recurrence-free survival (RFS), which was defined by Gastman et al1 as time from diagnosis to local, regional, or distant recurrence. From the data presented in Supplemental Fig 1 of the article by Gastman et al,1 the sensitivity, specificity, positive predictive value, and negative predictive value of a class 2 score in predicting 5-year RFS among patients with T1 melanomas were 33%, 91%, 20%, and 95%, respectively.1 If the 31-gene expression profile test was applied to 100 hypothetical patients with T1 melanoma and a 5-year RFS rate of 94%,1 there would be 2 true positives, 9 false positives, 4 false negatives, and 85 true negatives; thus, 85% of patients would be unaffected, 13% could be harmed by an incorrect result, and 2% could potentially benefit from a correctly anticipated local, regional, or distant recurrence. Journal of the American Academy of Dermatology 2019 80, e161-e162DOI: (10.1016/j.jaad.2018.11.063) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions