Integration of a 31-Gene Expression Profile Into Clinical Decision-Making in the Treatment of Cutaneous Melanoma

Abstract

Background The practice of utilizing gene expression profile (GEP) for the evaluation and treatment of cutaneous melanomas has been found to predict the risk of sentinel-node metastasis and recurrence. Information obtained from this assay has been used to determine clinical decision-making, including serving as an indication for sentinel lymph node biopsy and also for the intensity of screening measures. Methods Herein we present our early experience in utilizing 31-GEP in intermediate melanomas and its effect on clinical management. A retrospective review was conducted of patients who had undergone treatment for melanoma whose tumors had been subjected to 31-GEP. Additionally, patient characteristics, attributes of the original tumor biopsied, findings on final pathology, and procedures performed were evaluated. Results 31-GEP stratified patients into 4 groups; groups 1A and 1B are considered low risk of metastasis or recurrence, while 2A and 2B are considered high risk. Over the study period, 31-GEP was conducted on 26 cutaneous melanoma patients. Testing and treatment data are available for 23 of these patients. Eleven patients were found to be low risk (9 as 1A, 2 as 1B), 12 were found to be high risk (4 as 2A, 8 as 2B). Decision-making was altered such that sentinel lymph node biopsy was omitted in 2 cases in which the patients were found to be low risk with age >65 years. Discussion In 8 cases of node-negative disease in genetically high-risk patients, surveillance measures were augmented with positron emission tomography/computed tomography. Utilization of 31-GEP is ongoing at our institution.

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.…”

“…[36,[39][40][41][42]50]. Studies also suggest that GEP tests may provide more nuanced information to assist dermatologists in managing CM with regards to SLNBx in conjunction with current NCCN guidelines [37,38,43,46,49,54] and potentially reduce unnecessary testing, procedures, and annual healthcare expenditures [28,[60][61][62][63][64][65][66]. While meta-analyses are not yet available for all prognostic CM GEP tests, two recent separate studies [49,67] found similar and robust evidence for the 31-GEP test, which was also supported by clinical recommendations (including A-strength recommendations for the use of the 31-GEP to guide management of patients with negative SLNBx) from an independent consensus panel [10].…”

The Integrated 31-Gene Expression Profile (i31-GEP) Test for Cutaneous Melanoma Outperforms a Clinicopathologic-only Nomogram at Identifying Patients who can Forego Sentinel Lymph Node Biopsy

“…Multiple studies have demonstrated that clinicians combine 31-GEP results with other factors to align management plans with patient risk. [26][27][28] No DISCUSSION Table 3. Reclassification of risk in patients with 5-10% SLN positivity risk ("consider" SLNB; T1aHR-T1b) for whom SLNB guidance is not definitive Limitations of this study include its retrospective nature and that this selected population from primarily surgical centers may not represent the general population.…”