Utility of a 31-gene expression profile for predicting outcomes in patients with primary cutaneous melanoma referred for sentinel node biopsy

Using a 31-Gene Expression Profile Test to Stratify Patients with Stage I–II Cutaneous Melanoma According to Recurrence Risk: Update to a Prospective, Multicenter Study

“…A limitation of the study is that relatively few events limited Cox regression to univariate analysis for DFS. However, previous studies on the 31-GEP have consistently shown that the 31-GEP is a significant independent predictor for relapse [ 10 , 11 , 12 , 13 ]. The primary purpose of the current analysis was to provide longer follow-up time to confirm the results from the previous publication.…”

“…We previously reported results from a prospective study using a gene expression profile test (31-GEP) that uses the expression of discriminating and control genes from the primary tumor to stratify patients with stage IB–II CM by recurrence risk [ 8 ]. The 31-GEP classifies patients as being at low (Class 1) or high (Class 2) risk of recurrence or distant metastasis and can further classify them as having the lowest (Class 1A), intermediate (Class 1B/2A), or highest (Class 2B) risk [ 9 , 10 , 11 , 12 , 13 ]. Despite a relatively short follow-up of 2.2 years in the previously published study, patients with a Class 2 result experienced recurrences and had lower survival rates than patients with a Class 1 result, who did not experience recurrences.…”

Improved cutaneous melanoma survival stratification through integration of 31-gene expression profile testing with the American Joint Committee on Cancer 8th Edition Staging

“…Importantly, this study and previous studies have aligned with the suggested recommendations: the 31-GEP adds value to clinicopathologic features for outcomes prognosis [3,14], compares favorably and adds value to SLN biopsy for predicting the risk of recurrence [3], adds clinical utility to patient care [15], and is reproducible and consistent across studies [3,6,14]. Furthermore, multiple prospective studies have been published on the validity and utility of the 31-GEP test, including studies that have demonstrated how clinicians could use the test to make more informed patient care decisions [16][17][18]. Chi-square statistic for log-rank tests performed to determine differences in melanoma-specific survival by 31-GEP result for the entire length of available follow-up.…”

Comments on Post-Publication Discussion of “Evaluation of a Gene Expression Profiling Assay in Primary Cutaneous Melanoma”

“…In this context, consideration should be given to the authors' conclusions about 31-gene expression profile (GEP) testing, which contradict all retrospective and prospective validation studies to date. [6][7][8] If, as we strongly suspect, this study reports an underpowered multivariate analysis, it is impossible to draw any conclusions about factors not found to be significant in a model as the lack of statistical power may obscure relationships known to be significant. The authors have made interpretive leaps about the relative value of 31-GEP testing not supported by their study design and analysis plan, while simultaneously omitting interpretive critiques that could be similarly applied to the reported nonsignificance of various AJCC pathologic factors (SLNB in original manuscript and BT in the author responses).…”