DecisionDx®-SCC Identifies High-Risk Squamous Cell Carcinoma Patients for Adjuvant Radiation Therapy or Deferred Treatment

In a recent study published in the International Journal of Radiation Oncology • Biology • Physics, Castle Biosciences, Inc. has showcased the efficacy of their DecisionDx-SCC test. This test is designed to predict the risk of metastasis in patients with cutaneous squamous cell carcinoma (SCC) and to identify those who would benefit most from adjuvant radiation therapy (ART).

The study found that patients with the highest risk of metastasis, classified as Class 2B by the DecisionDx-SCC test, showed significantly improved metastasis-free survival (MFS) rates when treated with ART. Specifically, these Class 2B patients had MFS rates that were 50% higher on average compared to those who did not receive ART. Additionally, these patients experienced a notable deceleration in disease progression.

Sarah T. Arron, M.D. Ph.D., the study's lead author, emphasized the importance of the DecisionDx-SCC test in clinical decision-making. According to Dr. Arron, determining which high-risk SCC patients would benefit from radiation therapy, based on traditional risk assessment and staging systems, can be challenging. The DecisionDx-SCC test, however, provides a clearer indication of which patients are most likely to benefit from ART, potentially improving patient outcomes and reducing unnecessary treatments.

Key findings from the study, which included 920 patients, highlighted the following:

1. Impact on Class 2B Patients: Patients with a DecisionDx-SCC Class 2B result who received ART had a 50% higher MFS rate compared to Class 2B patients who did not receive ART. The study also noted that Class 2B patients treated with ART had a significantly longer projected time to metastasis, nearly five times longer than those who did not receive ART.

2. Independent Risk Factor: The DecisionDx-SCC Class 2B result was identified as the only independent risk factor that effectively predicted which patients would benefit most from ART. Other risk factors included differentiation status, fat invasion, perineural invasion, and established risk categories from the National Comprehensive Cancer Network (NCCN) and staging systems from Brigham and Women's Hospital and the American Joint Committee on Cancer.

3. Limited Benefit for Class 1 Patients: Patients with high-risk clinicopathologic features but a DecisionDx-SCC Class 1 result (indicating lower metastatic risk) did not show significant benefit from ART. This suggests that Class 1 patients, given their low risk of metastasis and minimal benefit from ART, may consider deferring the treatment.

The DecisionDx-SCC test is a 40-gene expression profile test that uses tumor biology to stratify the risk of metastasis in SCC patients. Patients are categorized into Class 1 (lower risk), Class 2A (higher risk), or Class 2B (highest risk) based on their test results. This stratification helps guide clinical decision-making regarding the use of ART.

Castle Biosciences aims to transform disease management through innovative diagnostic tests that improve patient care. Their current portfolio includes tests for various skin cancers, Barrett’s esophagus, mental health conditions, and uveal melanoma. The company is also working on developing tests for other diseases with high clinical needs.

In summary, the DecisionDx-SCC test has proven to be a valuable tool in identifying high-risk SCC patients who would benefit from ART, thereby aiding clinicians in making more informed treatment decisions and potentially improving patient outcomes.

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