On September 27, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data demonstrating the ability of its DecisionDx-SCC test to provide clinically impactful risk stratification in high-risk SCC patient sub-populations (i.e., patients with suppressed immune systems in this study) to guide potential treatment intensification, such as adjuvant radiation therapy (ART) (Press release, Castle Biosciences, SEP 27, 2024, View Source [SID1234646895]). The data will be shared in an oral presentation at the American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting, being held Sept. 29-Oct. 2 in Washington, D.C. "The DecisionDx-SCC test has been validated to independently predict likelihood of metastasis beyond staging and clinicopathologic risk factors to help inform important treatment decisions for patients with SCC," said Shlomo A. Koyfman, M.D., lead study author and radiation oncologist at Cleveland Clinic.1-3 "The data we are sharing at ASTRO highlights the utility of the test in immune suppressed patients with lower-stage SCC tumors, who may have an elevated risk of metastasis due to their immune status and thus may benefit from intensified surveillance and adjuvant treatments, such as radiation, following tumor removal to reduce this risk."4,5
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Details regarding Castle’s oral presentation at ASTRO are included below:
Abstract title: Use of the 40-gene expression profile (40-GEP) test to identify immune suppressed patients with Brigham and Women’s Hospital (BWH) T1-T2a cutaneous squamous cell carcinoma (cSCC) at higher risk of metastasis: Implications for adjuvant radiation
Abstract ID: 1065
Lead Authors: Shlomo A. Koyfman, M.D., and Karina Brito, Cleveland Clinic
Session Type: Quick Pitch
Session: QP 12 – Sarcoma 2: Advancing Treatment Frontiers in Cutaneous Malignancies and Sarcoma
Date & Time: Tuesday, Oct. 1, 2:30-2:40 p.m. Eastern Time
Location: Room 151
Summary: Data from an independent validation cohort of 954 SCC patients with at least one National Comprehensive Cancer Network (NCCN) high-risk factor and DecisionDx-SCC test results were analyzed for patients with BWH T1 and T2a tumors with no residual tumor after Mohs surgery; 441 patients with BWH T1 tumors and 336 with BWH T2a tumors were included in the study cohort. Patients with T1 tumors had similar metastasis-free survival (MFS) rates regardless of immune status yet were further stratified by their DecisionDx-SCC test result (3-year MFS: Class 1 test result: 96.9% vs. Class 2A/2B test result: 88.6%, p<0.001). Immune suppressed patients with T2a tumors had significantly worse MFS than immune competent patients with T2a tumors (71.4% vs. 91.2%, p<0.001). DecisionDx-SCC further stratified immune suppressed patients with T2a tumors into those with more favorable (Class 1 test result; 3-yr MFS of 83%) and less favorable survival (Class 2A/2B test result; 3-yr MFS of 57%). Given the study data, treatment intensification such as ART should be strongly considered in immune suppressed patients with BWH T2a SCC tumors guided by DecisionDx-SCC test results.
The full text abstract is available in the ASTRO Annual Meeting Portal and will be published in the International Journal of Radiation Oncology • Biology • Physics (Red Journal).
About DecisionDx-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to stratify risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management and guide decision-making regarding the use of adjuvant radiation therapy. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that the test can significantly improve risk-stratification when used with traditional staging systems and clinicopathologic risk factors to guide risk-aligned management and treatment decisions. Learn more at www.CastleBiosciences.com.