Integrating the Melanoma 31-Gene Expression Profile Test with Surgical Oncology Practice Within National Guideline and Staging Recommendations

Abstract

Aim: Define changes in clinical management resulting from use of the prognostic 31-gene expression profile (31-GEP) test for cutaneous melanoma in a surgical oncology practice. Patients & methods: Management plans for 112 consecutively tested patients with stage I–III melanoma were evaluated for duration and number of clinical visits, blood work and imaging. Results: 31-GEP high-risk (class 2; n = 46) patients received increased management compared with low-risk (class 1; n = 66) patients. Test results were most closely associated with follow-up and imaging. Of class 1 patients, 65% received surveillance intensity within guidelines for stage I–IIA patients; 98% of class 2 patients received surveillance intensity equal to stage IIB–IV patients. Conclusion: We suggest clinical follow-up and metastatic screening be adjusted according to 31-GEP test results.

Expert Consensus on the Use of Prognostic Gene Expression Profiling Tests for the Management of Cutaneous Melanoma: Consensus from the Skin Cancer Prevention Working Group

“…Furthermore, approximately 65% of class 1 results lead to surveillance intensity similar to AJCC8 stage I-IIA, while 98% of class 2 results lead to increased scrutiny, similar to patients with AJCC8 stage IIB-IV CM [64]. Overall, studies have found that 31-GEP class results had the potential to positively influence management decisions among physicians [63][64][65] and nonphysician providers [66], consistent with the augmented risk stratification provided by GEP testing.…”

“…Additional studies have also found GEP class results affected the frequency of physical exams (p \ 0.0001)[54] and of referrals (p \ 0.0001) [62], with significantly more physicians altering management and opting to refer CM patients with a 0.7-mm Breslow depth if they also had a GEP class 2 result (p \ 0.05) [63]. Furthermore, approximately 65% of class 1 results lead to surveillance intensity similar to AJCC8 stage I-IIA, while 98% of class 2 results lead to increased scrutiny, similar to patients with AJCC8 stage IIB-IV CM [64]. Overall, studies have found that 31-GEP class results had the potential to positively influence management decisions among physicians [63][64][65] and nonphysician providers [66], consistent with the augmented risk stratification provided by GEP testing.…”

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.…”

Incorporating Prognostic Gene Expression Profile Assays into the Management of Cutaneous Melanoma: An Expert Consensus Panel

“…After screening the articles, 32 met inclusion criteria and were distributed to the panelists for review prior to the roundtable discussion. Of these articles, the number of papers that specifically studied the validity, accuracy, or clinical utility of each test was: 22 for the 31-GEP test 4,[19][20][21][22][23][24][26][27][28][29][30][31][34][35][36][37][38][39][40][41][42] , 2 for the 11-GEP test 11,34 , and 7 for the 8-GEP + CP test. 5,13,23,[43][44][45][46]…”

“…For the 8-GEP + CEP test, a validation study analyzing the test's ability to predict SLNB positivity found that this model has a NPV of 90.5% (95% Confidence Interval [CI]: 77.9-96.2%) in T1-4 CMs. 44 In comparing the three GEP tests, the panel consensus was that there were significantly more studies supporting the validity, accuracy, and clinical utility of the 31-GEP test compared to the 11-GEP and 8-GEP + CP tests (22 studies validating the 31-GEP test 4,[19][20][21][22][23][24][26][27][28][29][30][31][34][35][36][37][38][39][40][41][42] , compared to just 2 studies validating the 11-GEP test 11,34 and 7 studies validating the 8-GEP + CP test 5,13,23,[43][44][45][46] ). Based on the limited studies for the 8-GEP + CP and the 11-GEP test, the panel concluded that there was insufficient data to assess their validity and utility or currently recommend usage in the clinical setting until further studies are performed.…”