title: Clinical impact of a 31-gene expression profile test for cutaneous melanoma in 156 prospectively and consecutively tested patients.
abstract: DecisionDx-Melanoma * is a 31-gene expression profile test that predicts the risk of metastasis in patients with primary cutaneous melanoma (CM). This study was designed to ascertain clinical management changes determined by the test outcome, which classifies CM patients being at low (Class 1) or high (Class 2) risk for recurrence.
  
  
  
  Medical charts were reviewed from 156 CM patients from six institutions (three dermatology and three surgical oncology practices) who were consecutively tested between May 2013 and December 2015. Clinical management data that were compiled and compared before and after receipt of the 31-gene expression test result included frequency of physical exams, frequency and modality of imaging, and referrals to surgical and medical oncologists.
  
  
  
  Forty-two percent of patients were Stage I, 47% were Stage II and 8% were Stage III. Overall, 95 patients (61%) were Class 1 and 61 (39%) were Class 2. Documented changes in management were observed in 82 (53%) patients, with the majority of Class 2 patients (77%) undergoing management changes compared to 37% of Class 1 patients (p < 0.0001 by Fisher's exact test). The majority (77/82, 94%) of these changes were concordant with the risk indicated by the test result (p < 0.0001 by Fisher's exact test), with increased management intensity for Class 2 patients and reduced management intensity for Class 1 patients.
  
  
  
  Molecular risk classification by gene expression profiling has clinical impact and influences physicians to direct clinical management of CM patients. The vast majority of the changes implemented after the receipt of test results were reflective of the low or high recurrence risk associated with the patient's molecular classification. Because follow-up data was not collected for this patient cohort, the study is limited for the assessment of the impact of gene expression profile based management changes on healthcare resource utilization and patient outcome.
authors.affiliation: a Thomas Jefferson University Hospital , Philadelphia , PA , USA ;
authors.forename: Adam C
authors.initials: AC
authors.lastname: Berger
authors.affiliation: b Surgical Associates of West Florida , Safety Harbor , FL , USA ;
authors.forename: Robert S
authors.initials: RS
authors.lastname: Davidson
authors.affiliation: c Florida Medical Clinic , Land O Lakes , FL , USA ;
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Poitras
authors.affiliation: d Midlands Clinic , Dakota Dunes , SD , USA ;
authors.forename: Indy
authors.initials: I
authors.lastname: Chabra
authors.affiliation: e Lubbock Dermatology and Skin Cancer Center , Lubbock , TX , USA ;
authors.forename: Richard
authors.initials: R
authors.lastname: Hope
authors.affiliation: e Lubbock Dermatology and Skin Cancer Center , Lubbock , TX , USA ;
authors.forename: Amy
authors.initials: A
authors.lastname: Brackeen
authors.affiliation: f Castle Biosciences Inc. , Friendswood , TX , USA ;
authors.forename: Clare E
authors.initials: CE
authors.lastname: Johnson
authors.affiliation: f Castle Biosciences Inc. , Friendswood , TX , USA ;
authors.forename: Derek J
authors.initials: DJ
authors.lastname: Maetzold
authors.affiliation: f Castle Biosciences Inc. , Friendswood , TX , USA ;
authors.forename: Brooke
authors.initials: B
authors.lastname: Middlebrook
authors.affiliation: f Castle Biosciences Inc. , Friendswood , TX , USA ;
authors.forename: Kristen M
authors.initials: KM
authors.lastname: Oelschlager
authors.affiliation: f Castle Biosciences Inc. , Friendswood , TX , USA ;
authors.forename: Robert W
authors.initials: RW
authors.lastname: Cook
authors.affiliation: f Castle Biosciences Inc. , Friendswood , TX , USA ;
authors.forename: Federico A
authors.initials: FA
authors.lastname: Monzon
authors.affiliation: g Miller Start Center for Cancer Care , San Antonio , TX , USA.
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Miller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D020869:Gene Expression Profiling / Q000379:methods*; D006801:Humans; D008297:Male; D008545:Melanoma / Q000453:epidemiology / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011446:Prospective Studies; D012306:Risk; D012878:Skin Neoplasms / Q000453:epidemiology / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D000096142:Cutaneous Malignant Melanoma
keywords: Clinical decision-making; disease management; gene expression profile; melanoma