On October 20, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from its prospective, multicenter DECIDE1 study in which DecisionDx-Melanoma test results influenced 85% of clinicians’ decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure, demonstrating the role of the test’s results in guiding risk-aligned patient management decisions (Press release, Castle Biosciences, OCT 20, 2022, View Source [SID1234622241]).
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"Melanoma is an aggressive and deadly disease, thus any decisions on whether to forego a procedure like an SLNB cannot be taken lightly," said J. Michael Guenther, M.D., surgical oncologist at St. Elizabeth Physicians in Edgewood, Kentucky. "The clinically actionable information that DecisionDx-Melanoma provides is precious to both doctors and patients. It enables me to have more productive conversations with my patients, so we can make shared, informed decisions about their overall care; this includes decisions on whether to pursue an SLNB if their risk of a positive sentinel lymph node is low."
The data was presented during the 19th International Congress of the Society for Melanoma Research (SMR), held Oct. 17-20 in Edinburgh, United Kingdom, through a poster (# P- 037) titled, "Clinical use of the 31-gene expression profile for informing sentinel lymph node biopsies: a prospective, multicenter study." The poster can be viewed here.
SLNB surgery is used to determine whether a patient’s melanoma has spread to the lymph node; the procedure has the potential for complications and returns a biopsy that is negative for metastatic spread in up to 88% of patients who undergo the procedure.2-3 DecisionDx-Melanoma is a gene expression profile risk stratification test designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. The test has been validated to identify patients who have less than a 5% risk of a positive SLN, indicating that these patients could safely forego the SLNB surgical procedure, and improve the yield of positive SLNBs by identifying patients more likely to have a positive SLNB result.4-5
Study highlights:
The prospective, multicenter study included patients with invasive cutaneous melanoma (tumors staged as T1a (and at least one high-risk feature), T1b and T2) who were considering the SLNB surgical procedure.
Clinicians received DecisionDx-Melanoma test results prior to making SLNB decisions and were asked which features influenced their decision on whether to perform the procedure. Potential influencing factors included patient preference, clinical and pathological features and DecisionDx-Melanoma results.
The data showed that DecisionDx-Melanoma test results influenced 85% of SLNB decisions, and that DecisionDx-Melanoma test results and patient preference played a significant role in influencing the decision to undergo or forego SLNB.
When DecisionDx-Melanoma test results influenced for SLNB, the procedure was performed in 92% of the cases in the study; similarly, when the test result influenced against SLNB, the decision was made to forego SLNB in 70% of cases. This data indicates that the test’s results in conjunction with current guidelines can guide risk-aligned clinical decision-making regarding the SLNB surgical procedure.
The use of DecisionDx-Melanoma test results in conjunction with current guidelines resulted in a significant reduction of SLNB procedures performed, most notably a 29% decrease in SLNBs performed for patients with a low-risk (Class 1A) test result, compared to SLNB decisions made based on a patient’s clinicopathologic risk factors alone (p<0.01).
As demonstrated in the study, DecisionDx-Melanoma test results can influence important clinical decisions regarding the SLNB surgical procedure. Additionally, the use of DecisionDx-Melanoma test results could help patients with low-risk (Class 1A) test results, whose tumor biology indicates that they can safely forego the procedure and still experience positive outcomes, and their clinicians have more informed conversations regarding clinical decisions and avoid a potentially unnecessary procedure.
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.