Study: Test Improves the Risk Stratification of Patients with Stage I Melanoma

The test was compared with the American Joint Committee on Cancer 8th Edition Staging.

Results from a recent study showed the potential of a 31-gene expression profile (31-GEP) test in improving the prognosis for patients diagnosed with stage I cutaneous melanoma.

Despite being considered at low risk for metastasis or melanoma-specific death, patients with stage I cutaneous melanoma represent a substantial portion of annual melanoma-related deaths. The 31-GEP test, which categorizes patients into low (Class 1A), intermediate (Class 1B/2A), or high (Class 2B) risk groups, has been validated to offer prognostic insights irrespective of conventional staging methods.

The study combined data from previous trials involving 1,261 patients ("combined cohort"). According to the results, Class 1A patients exhibited significantly higher rates of recurrence-free survival (RFS) versus those in Class 1B/2A or Class 2B (97.3%, 88.6%, 77.3% respectively; P < 0.001). This differentiation in risk was even more pronounced than that provided by the American Joint Committee on Cancer (AJCC) 8th edition staging system. Analysis of a separate real-world cohort (n = 5,651) clinically tested patients diagnosed between 2013 and 2018, and linked to outcomes data from the NCI Surveillance, Epidemiology, and End Results (SEER) Program registries, corroborated these findings. The SEER cohort showed superior melanoma-specific survival (MSS) stratification by the test compared to AJCC8 staging.

"The data presented here confirm that the 31-GEP test has utility to address an unmet need in melanoma patient care—identifying patients classified as low risk by AJCC staging, but who have high-risk tumor biology and are more likely to experience poor outcomes," the concluded in the study. "This study demonstrates that the 31-GEP added significant prognostic information beyond that of the clinicopathological factors included in standard AJCC8 CM staging. Thus, incorporating the 31-GEP into clinical practice may benefit patients by providing additional information that clinicians can use to make personalized, risk-aligned treatment and surveillance management plans."

Source: Podlipnik S, Martin BJ, Morgan-Linnell SK, et al. The 31-Gene Expression Profile Test Outperforms AJCC in Stratifying Risk of Recurrence in Patients with Stage I Cutaneous Melanoma. Cancers. 2024;16(2):287. doi:https://doi.org/10.3390/cancers16020287