An independent review of currently available literature showed that the 31-gene expression profile test in cutaneous melanoma may be supported by more evidence than designations by three major dermatology organizations would indicate.
“A 31-gene expression profile (31-GEP) test is currently available for patients diagnosed with cutaneous melanoma; this test helps inform patients’ individual treatment plans, especially when combined with traditional biomarkers,” Danielle P. Dubin, BA, of the department of dermatology at the Icahn School of Medicine at Mount Sinai, and colleagues
wrote. “The objective of this study was to review the current literature and establish the level of evidence for a cutaneous melanoma 31-GEP test.”
The researchers conducted a review of seven development and validation studies for the test. They then applied the positive and negative attributes of each study to the level of evidence criteria for the American Joint Committee on Cancer, National Comprehensive Cancer Network (NCCN) and American Academy of Dermatology (AAD), all of which publish guidelines for managing melanoma.
Level I evidence is defined as that which shows consistent results from multiple large, well-designed and well-conducted national and international prospective or retrospective studies that involve appropriate patient populations, endpoints and therapeutic interventions. Evaluation of level I studies should be based on methodology, according to the authors.
For level II evidence, at least one large, well-designed and well-conducted trial in appropriate patient populations with accordingly appropriate endpoints and external validation is necessary.
Level III evidence may be “somewhat problematic” due to number, size or quality of studies, inconsistent findings or appropriateness of patient selection or outcomes.
Level IV evidence, then, is insufficient due to a dearth of appropriate studies.
The investigators in the current study classified the 31-GEP test as level I/II based on American Joint Committee on Cancer criteria, level I-IIIB for the NCCN and level IIA for AAD criteria.
By contrast, the test is unrated by both the American Joint Committee on Cancer and the NCCN. Moreover, the AAD rates 31-GEP as being supported by level II/IIIC evidence.
“Differences between the authors’ findings and official published ratings may be attributed to chronological issues, as many of the studies were not yet published when the aforementioned organizations conducted their reviews,” the researchers concluded. They noted challenges in applying NCCN criteria to 31-GEP because that organization’s guidelines were intended for use in evaluating predictive markers. “Nevertheless, based upon the most current data available, integration of the 31-GEP test into clinical practice may be warranted in certain clinical situations.” – by Rob Volansky
Disclosures: Dubin reports no relevant financial disclosures. The other two authors report they serve on the advisory board of Castle Biosciences.