Bradley N Greenhaw1, Kyle R Covington2, Sarah J Kurley2, Yildiray Yeniay3, Nhat Anh Cao4, Kristen M Plasseraud2, Robert W Cook2, Eddy C Hsueh5, Brian R Gastman6, Maria L Wei7. 1. Dermatology Center of North Mississippi, Tupelo, Mississippi. 2. Castle Biosciences, Inc, Friendswood, Texas. 3. University of California-San Francisco, San Francisco, California. 4. San Francisco Veterans Affairs Medical Center, San Francisco, California. 5. Saint Louis University, St Louis, Missouri. 6. Cleveland Clinic Lerner Research Institute, Cleveland, Ohio. 7. University of California-San Francisco, San Francisco, California; San Francisco Veterans Affairs Medical Center, San Francisco, California. Electronic address: maria.wei@ucsf.edu.
Abstract
BACKGROUND: Multiple studies have reported on the accuracy of the prognostic 31-gene expression profile test for cutaneous melanoma. Consistency of the test results across studies has not been systematically evaluated. OBJECTIVE: To assess the robustness of the prognostic value of the 31-gene expression profile. METHODS: Raw data were obtained from studies identified from systematic review. A meta-analysis was performed to determine overall effect of the 31-gene expression profile. Clinical outcome metrics for the 31-gene expression profile were compared with American Joint Committee on Cancer staging. RESULTS: Three studies met inclusion criteria; data from a novel cohort of 211 patients were included (n = 1,479). Five-year recurrence-free and distant metastasis-free survival rates were 91.4% and 94.1% for Class 1A patients and 43.6% and 55.5% for Class 2B patients (P < .0001). Meta-analysis results showed that Class 2 was significantly associated with recurrence (hazard ratio 2.90; P < .0001) and distant metastasis (hazard ratio 2.75; P < .0001). The 31-gene expression profile identified American Joint Committee on Cancer stage I to III patient subsets with high likelihood for recurrence and distant metastasis. Sensitivity was 76% (95% confidence interval 71%-80%) and 76% (95% confidence interval 70%-82%) for each end point, respectively. When 31-gene expression profile and sentinel lymph node biopsy results were considered together, sensitivity and negative predictive value for distant metastasis-free survival were both improved. CONCLUSION: The 31-gene expression profile test consistently and accurately identifies melanoma patients at increased risk of metastasis, is independent of other clinicopathologic covariates, and augments current risk stratification by reclassifying patients for heightened surveillance who were previously designated as being at low risk. Published by Elsevier Inc.
BACKGROUND: Multiple studies have reported on the accuracy of the prognostic 31-gene expression profile test for cutaneous melanoma. Consistency of the test results across studies has not been systematically evaluated. OBJECTIVE: To assess the robustness of the prognostic value of the 31-gene expression profile. METHODS: Raw data were obtained from studies identified from systematic review. A meta-analysis was performed to determine overall effect of the 31-gene expression profile. Clinical outcome metrics for the 31-gene expression profile were compared with American Joint Committee on Cancer staging. RESULTS: Three studies met inclusion criteria; data from a novel cohort of 211 patients were included (n = 1,479). Five-year recurrence-free and distant metastasis-free survival rates were 91.4% and 94.1% for Class 1A patients and 43.6% and 55.5% for Class 2B patients (P < .0001). Meta-analysis results showed that Class 2 was significantly associated with recurrence (hazard ratio 2.90; P < .0001) and distant metastasis (hazard ratio 2.75; P < .0001). The 31-gene expression profile identified American Joint Committee on Cancer stage I to III patient subsets with high likelihood for recurrence and distant metastasis. Sensitivity was 76% (95% confidence interval 71%-80%) and 76% (95% confidence interval 70%-82%) for each end point, respectively. When 31-gene expression profile and sentinel lymph node biopsy results were considered together, sensitivity and negative predictive value for distant metastasis-free survival were both improved. CONCLUSION: The 31-gene expression profile test consistently and accurately identifies melanomapatients at increased risk of metastasis, is independent of other clinicopathologic covariates, and augments current risk stratification by reclassifying patients for heightened surveillance who were previously designated as being at low risk. Published by Elsevier Inc.
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Authors: Eric D Whitman; Vadim P Koshenkov; Brian R Gastman; Deri Lewis; Eddy C Hsueh; Ho Pak; Thomas P Trezona; Robert S Davidson; Michael McPhee; J Michael Guenther; Paul Toomey; Franz O Smith; Peter D Beitsch; James M Lewis; Andrew Ward; Shawn E Young; Parth K Shah; Ann P Quick; Brian J Martin; Olga Zolochevska; Kyle R Covington; Federico A Monzon; Matthew S Goldberg; Robert W Cook; Martin D Fleming; David M Hyams; John T Vetto Journal: JCO Precis Oncol Date: 2021-09-13