On October 5, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported a new study demonstrating DecisionDx-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM) (Press release, Castle Biosciences, OCT 5, 2023, View Source [SID1234635703]). The study is available online in Anticancer Research.
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"Nearly 90% of patients receive a negative result after undergoing the sentinel lymph node biopsy (SLNB) procedure,1-2 indicating there is a significant need for more precise methods to identify which patients can safely forego the surgery and still experience good outcomes," said Michael Tassavor, M.D., study author, board-certified dermatologist and fellowship-trained Mohs surgeon currently practicing in New Jersey. "By providing an accurate prediction of a patient’s likelihood of having a positive SLN, DecisionDx-Melanoma test results can inform important conversations between clinicians and patients and provide added confidence in decisions to proceed without the surgery if a patient’s risk is low."
The study evaluated the performance of two tools used to identify patients at low and high risk of SLN positivity:
Castle’s DecisionDx-Melanoma test, which uses advanced algorithms to integrate a patient’s clinical and pathologic factors with his/her tumor biology to provide a personalized prediction of the risk of SLN positivity, and melanoma recurrence and metastasis.
The MSKCC nomogram, which uses logistic regression and only clinical and pathologic factors to predict a patient’s SLN positivity risk.
Patients from previously published multicenter cohorts with T1-T2 tumors who had undergone the SLNB procedure (n=465) were analyzed using both DecisionDx-Melanoma and the MSKCC nomogram. Following current National Comprehensive Cancer Network (NCCN) guidelines, a risk prediction of less than 5% in the study was considered low risk for SLN positivity, where patients could safely forego the SLNB procedure. A true-to-false-negative ratio was evaluated using this 5% risk threshold. A 5% threshold represents 19 truly negative nodes for one positive SLN missed (19:1 ratio; 1/20 [5%]), meaning that for every 100 patients who avoided SLNB based on NCCN criteria, 5 would have had a missed positive SLN.
The DecisionDx-Melanoma test resulted in a 36:1 true-to-false-negative ratio (108/3), meaning that for every 100 patients who avoided SLNB based on the test’s results, only 2.7 would have had a positive SLN. This is well below the 5% low-risk threshold established by NCCN. DecisionDx-Melanoma’s performance was better than that of the MSKCC nomogram, which resulted in a 9:1 true-to-false-negative ratio, suggesting that for every 100 patients avoiding SLNB using the MSKCC nomogram, 10 would have had a positive SLN. DecisionDx-Melanoma also demonstrated better accuracy in predicting SLN positivity, including higher sensitivity (95% vs. 81%) and negative predictive value (97% vs. 90%) than the MSKCC nomogram.
Importantly, in patients with T1 tumors, for whom the decision to perform SLNB is least clear, using the DecisionDx-Melanoma test to help guide decision-making could have reduced the number of SLNBs by 43.7%, compared with standard NCCN SLNB guidance using American Joint Committee on Cancer staging, while maintaining a low false-negative rate.
DecisionDx-Melanoma has been validated to identify patients who have less than a 5% risk of a positive SLN, indicating that these patients may consider avoiding the SLNB surgical procedure.3-4 The results of this study support these findings and demonstrate that DecisionDx-Melanoma outperforms the MSKCC nomogram in identifying patients at low risk of SLN positivity. The study provides further evidence that using DecisionDx-Melanoma to help guide decisions regarding the SLNB procedure could improve patient selection, reduce unnecessary surgical procedures and ultimately improve the care of patients with melanoma.
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 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2023, DecisionDx-Melanoma has been ordered more than 137,200 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.