On May 5, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a clinical utility model for its cutaneous squamous cell carcinoma (SCC) prognostic test, DecisionDx-SCC, for patients diagnosed with high-risk cutaneous SCC (Press release, Castle Biosciences, MAY 5, 2020, View Source [SID1234557053]). The test is expected to launch commercially in the second half of 2020.
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The article titled, "Integrating gene expression profiling into NCCN high-risk cutaneous squamous cell carcinoma management recommendations: impact on patient management," was published in the peer-reviewed journal, Current Medical Research and Opinion (CMRO).
This publication proposes a framework for integration of DecisionDx-SCC into existing management pathways for a risk-appropriate approach in high-risk cutaneous SCC patients (as defined by having one or more high-risk factors and consistent with the National Comprehensive Cancer Network (NCCN) guidelines).
"Castle’s DecisionDx-SCC test is designed to stratify risk of regional or distant metastasis in high-risk cutaneous SCC patients," said Aaron Farberg, M.D., first author, Icahn School of Medicine at Mount Sinai, New York and Arkansas Dermatology Skin Cancer Center, Little Rock, Arkansas. "This manuscript proposes a framework for clinical use of this test, along with current risk stratification tools within established management pathways. The expectation is that the test will enable more informed clinical decisions about adjuvant therapy and other management options."
Disease and Study Background
Approximately 1 million patients are diagnosed with SCC of the skin in the U.S. each year, and the incidence continues to grow; while the majority of patients have a favorable prognosis, approximately 200,000 patients are identified as high risk.
NCCN guidelines for SCC define treatment pathways based on risk of local recurrence or metastasis. For SCC, there are two clinicopathologically defined categories: low risk and high risk. NCCN defines high risk as SCC patients with one or more of several high-risk clinicopathologic features.
The study objective was to integrate gene expression profiling into the management of high-risk SCC within NCCN guidelines to improve risk-aligned management recommendations.
DecisionDx-SCC stratifies patients into three categories based on risk of metastasis: Class 1 (low-risk), Class 2A (high-risk) and Class 2B (highest-risk).This study was designed to evaluate possible changes in management for 300 NCCN high-risk cutaneous SCC patients, when considering DecisionDx-SCC test results.
Study Findings
Combining DecisionDx-SCC class with American Joint Committee on Cancer T stage identified a group of 159 low-risk patients (Class 1, T1-T2) with a 7.5% rate of metastasis. Similarly, combining test results with Brigham and Women’s Hospital staging identified 173 patients with a metastasis rate of 8.1%. Rates in both groups approached the metastasis rate of 6% observed for the general cutaneous SCC patient population.
By comparison, Class 2B patients in the study (n=24) had rates of metastasis equal to or surpassing 50%, regardless of the staging system with which the Class 2B result was combined, a rate that may warrant an NCCN-defined, high intensity management plan.
Following incorporation of DecisionDx-SCC results with T stage for 300 patients with NCCN high-risk features, more than 50% would have been recommended a low intensity management plan, while 34-39% would be recommended for a moderate intensity plan and only 8% for a high intensity plan.
The DecisionDx-SCC test is the second skin cancer test discovered, developed and validated by Castle Biosciences.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (SCC) is one of the most common cancers. Approximately 1 million patients are diagnosed with SCC each year in the U.S. While the majority of patients have a favorable prognosis, approximately 200,000 patients are identified as high risk. National guidelines provide for broad, aggressive treatment plan recommendations relative to low-risk patients. Traditional clinicopathologic based risk-factor staging systems suffer from low positive predictive value; meaning many more patients are classified as high risk than actually develop metastatic disease. This may lead to over- and under-treatment of a substantial number of cutaneous SCC patients. To address this clinical need, Castle Biosciences has developed a gene expression profile test designed to improve upon current staging systems and identify patients with cutaneous SCC at high risk for metastasis, in order to enable more informed, objective clinical decisions regarding adjuvant therapy and other management options.