Pedram Gerami1, Robert W Cook2, Maria C Russell3, Jeff Wilkinson4, Rodabe N Amaria5, Rene Gonzalez6, Stephen Lyle7, Gilchrist L Jackson8, Anthony J Greisinger9, Clare E Johnson2, Kristen M Oelschlager2, John F Stone4, Derek J Maetzold2, Laura K Ferris10, Jeffrey D Wayne11, Chelsea Cooper12, Roxana Obregon12, Keith A Delman3, David Lawson3. 1. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Robert H. Lurie Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. Electronic address: pgerami@nmff.org. 2. Castle Biosciences Inc, Friendswood, Texas. 3. Winship Cancer Institute of Emory University, Atlanta, Georgia. 4. St Joseph's Hospital and Medical Center, Phoenix, Arizona. 5. University of Texas MD Anderson Cancer Center, Houston, Texas. 6. University of Colorado Denver, Denver, Colorado. 7. University of Massachusetts Medical Center, Worcester, Massachusetts. 8. Kelsey-Seybold Clinic, Houston, Texas. 9. Kelsey Research Foundation, Houston, Texas. 10. Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 11. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Department of Surgery-Surgical Oncology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 12. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Abstract
BACKGROUND: A gene expression profile (GEP) test able to accurately identify risk of metastasis for patients with cutaneous melanoma has been clinically validated. OBJECTIVE: We aimed for assessment of the prognostic accuracy of GEP and sentinel lymph node biopsy (SLNB) tests, independently and in combination, in a multicenter cohort of 217 patients. METHODS: Reverse transcription polymerase chain reaction (RT-PCR) was performed to assess the expression of 31 genes from primary melanoma tumors, and SLNB outcome was determined from clinical data. Prognostic accuracy of each test was determined using Kaplan-Meier and Cox regression analysis of disease-free, distant metastasis-free, and overall survivals. RESULTS: GEP outcome was a more significant and better predictor of each end point in univariate and multivariate regression analysis, compared with SLNB (P < .0001 for all). In combination with SLNB, GEP improved prognostication. For patients with a GEP high-risk outcome and a negative SLNB result, Kaplan-Meier 5-year disease-free, distant metastasis-free, and overall survivals were 35%, 49%, and 54%, respectively. LIMITATIONS: Within the SLNB-negative cohort of patients, overall risk of metastatic events was higher (∼30%) than commonly found in the general population of patients with melanoma. CONCLUSIONS: In this study cohort, GEP was an objective tool that accurately predicted metastatic risk in SLNB-eligible patients.
BACKGROUND: A gene expression profile (GEP) test able to accurately identify risk of metastasis for patients with cutaneous melanoma has been clinically validated. OBJECTIVE: We aimed for assessment of the prognostic accuracy of GEP and sentinel lymph node biopsy (SLNB) tests, independently and in combination, in a multicenter cohort of 217 patients. METHODS: Reverse transcription polymerase chain reaction (RT-PCR) was performed to assess the expression of 31 genes from primary melanoma tumors, and SLNB outcome was determined from clinical data. Prognostic accuracy of each test was determined using Kaplan-Meier and Cox regression analysis of disease-free, distant metastasis-free, and overall survivals. RESULTS: GEP outcome was a more significant and better predictor of each end point in univariate and multivariate regression analysis, compared with SLNB (P < .0001 for all). In combination with SLNB, GEP improved prognostication. For patients with a GEP high-risk outcome and a negative SLNB result, Kaplan-Meier 5-year disease-free, distant metastasis-free, and overall survivals were 35%, 49%, and 54%, respectively. LIMITATIONS: Within the SLNB-negative cohort of patients, overall risk of metastatic events was higher (∼30%) than commonly found in the general population of patients with melanoma. CONCLUSIONS: In this study cohort, GEP was an objective tool that accurately predicted metastatic risk in SLNB-eligible patients.
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