31-gene expression profile test may aid in melanoma stratification

The 31-gene expression profile test demonstrated consistent sensitivity in identifying patients with melanoma at risk for recurrence or distant metastasis, according to a study.

“Multiple studies have reported on the accuracy of the prognostic 31-gene expression profile test for cutaneous melanoma,” Bradley N. Greenhaw, MD, of the Dermatology Center of North Mississippi, and colleagues wrote. “Consistency of the test results across studies has not been systematically evaluated.”

In the systematic review, Greenhaw and colleagues culled raw data from three studies investigating the robustness of the prognostic capability of the 31-gene expression profile as compared with American Joint Committee on Cancer staging. In addition to patients from the three previously conducted studies, 211 patients from a novel cohort were included, for a total of 1,479 patients.

Results at 5 years showed that recurrence-free survival was 91.4% and distant metastasis-free survival was 94.1% for class 1A patients. By comparison, at 5 years, class 2B patients demonstrated a recurrence-free survival rate of 43.6% and a distant metastasis-free survival rate of 55.5% (P < .0001).

The findings showed a significant association between class 2 status and both recurrence (HR = 2.90; P < .0001) and distant metastasis (HR = 2.75; P < .0001).

Regarding the 31-gene expression profile, the researchers reported that this test identified American Joint Committee on Cancer stage I to III patient subsets who were likely to recur or experience distant metastasis. The sensitivity of the gene test was 76% (95% CI, 71%-80%) for recurrence-free survival and 76% (95% CI, 70%-82%) for distant metastasis-free survival.

Concurrent consideration of both the 31-gene expression profile and sentinel lymph node biopsy results yielded improvements in both the sensitivity and negative predictive value for distant metastasis-free survival.

The researchers concluded that the 31-gene expression profile test is consistent and accurate in identifying patients with melanoma who carry an elevated metastasis risk. They added that the profile test also shows efficacy independent of other clinicopathologic covariates. “[The 31-gene expression profile test] augments current risk stratification by reclassifying patients for heightened surveillance who were previously designated as being at low risk,” they wrote.