Study Finds DecisionDx®-Melanoma Significantly Improves the Risk Stratification of Patients with Stage I Melanoma Compared to American Joint Committee on Cancer 8th Edition Staging
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Insights
The recent findings on the efficacy of DecisionDx-Melanoma in providing better risk stratification for stage I cutaneous melanoma patients represent a significant advancement in personalized cancer care. Unlike the traditional American Joint Committee on Cancer 8th Edition (AJCC8) staging, which is based on tumor size, location and spread, DecisionDx-Melanoma utilizes gene expression profiling to predict the risk of metastasis more accurately. This molecular diagnostic approach offers a more nuanced view of the patient's prognosis, which is critical for tailoring treatment strategies.
From a medical research perspective, the inclusion of over 5,000 patients from the SEER Program Registries in the study provides a robust data set that enhances the credibility of the findings. It's essential to note that the SEER database is a recognized source for cancer statistics, which lends further weight to the study's conclusions. The use of such a large cohort increases the generalizability of the results, suggesting that DecisionDx-Melanoma could potentially become a standard part of clinical decision-making for stage I melanoma patients.
As an oncologist, the prospect of integrating DecisionDx-Melanoma into routine clinical practice is promising. The test's ability to provide more precise information than AJCC8 staging could lead to more personalized treatment plans. For instance, patients identified as having a higher risk of metastasis might benefit from closer surveillance or adjuvant therapy, while those with lower risk could potentially avoid over-treatment and its associated morbidities.
However, it is important to balance enthusiasm with caution, as the long-term outcomes of patients managed with the guidance of DecisionDx-Melanoma are not yet fully understood. Ongoing research and real-world data collection will be vital to evaluate the impact of this test on overall survival and quality of life. Moreover, the cost-effectiveness of incorporating this test into routine care must be considered, as the financial implications for healthcare systems and patients are non-negligible.
The introduction of advanced diagnostic tools like DecisionDx-Melanoma has far-reaching implications for healthcare economics. By potentially improving risk stratification, this test could help in optimizing resource allocation and reducing unnecessary treatments, which are often costly. This is particularly relevant in the context of stage I melanoma, where overtreatment can lead to significant healthcare expenditures without corresponding improvements in patient outcomes.
However, the cost of the test itself must be weighed against the savings from avoided treatments and the potential benefits of improved outcomes. It is crucial to conduct a thorough cost-benefit analysis to ensure that the adoption of DecisionDx-Melanoma aligns with the goals of value-based care. Payers, including insurance companies and government healthcare programs, will be interested in the long-term cost implications of this test, especially if it becomes widely adopted as a standard of care.
Study results, which include 5,651 patients in the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program Registries, support the use of DecisionDx-Melanoma in stage I melanoma to help inform clinical decision-making
“Relying on staging alone to determine a melanoma patient’s prognosis misses patients with aggressive tumor biology who may be at higher risk of recurrence, metastasis or death from their disease,” said Sebastian Podlipnik, M.D., Ph.D., lead study author and dermatologist at the Hospital Clínic de
Traditionally, treatment pathways for CM have been based upon clinicopathologic AJCC8 staging, which provides population-based risk of progression estimates. Stage I CM tumors are considered low risk; however, since stage I encompasses a large group of patients diagnosed, many melanoma-specific deaths are seen in patients initially diagnosed with stage I disease. Thus, there is a clinical gap in the low-risk treatment pathway for stage I patients. DecisionDx-Melanoma was developed and validated to provide a tumor-specific risk of recurrence, independent of the current risk factors used in AJCC8 staging, specifically tumor thickness and ulceration. The test classifies patients as having a low risk (Class 1A), intermediate risk (Class 1B/2A) or high risk (Class 2B) of tumor recurrence, metastasis and melanoma-specific mortality based on the patient’s tumor biology. As a result of this risk-stratification information, DecisionDx-Melanoma is used clinically to help inform patient-specific treatment pathway decisions.
The new study in Cancers provides further information that DecisionDx-Melanoma testing could enable more precise risk stratification in stage I melanomas than provided by traditional staging to better inform risk-appropriate clinical management. This multi-center study analyzed data from nearly 7,000 patients with stage I CM to assess their five-year recurrence-free survival (RFS) and melanoma-specific survival (MSS) using the DecisionDx-Melanoma test. There were two cohorts of patients: a pooled cohort from previous studies (combined cohort, n=1,261) and a second, large, real-world cohort of unselected patients who received the DecisionDx-Melanoma test as part of their clinical care (patients diagnosed with CM between 2013–2018 who were linked to outcomes data from the National Cancer Institute’s SEER Program registries, n=5,651). The combined cohort was evaluated for RFS and MSS, and the SEER cohort was evaluated for MSS.
In both cohorts, DecisionDx-Melanoma provided greater separation between patients with high- and low-risk test results than seen between AJCC8 stage IA and IB, demonstrating the ability of the test to provide improved risk stratification over staging.
Combined cohort
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Separation of risk |
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RFS stratification |
DecisionDx-Melanoma test results |
Class 1A (low risk) ( |
AJCC8 staging |
Stage IA ( |
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SEER cohort
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Separation of risk |
MSS stratification |
DecisionDx-Melanoma test results |
Class 1A (low risk) ( |
AJCC8 staging |
Stage IA ( |
In the combined cohort, multivariable analysis showed that a DecisionDx-Melanoma Class 2B test result was the strongest predictor of recurrence in stage I CM (HR = 5.16, p < 0.001); similarly, in the SEER cohort, multivariable analysis indicated that a high-risk test result was the only significant predictor of melanoma-specific mortality in stage I patients (HR = 9.23, p < 0.001).
The data in this study support the use of DecisionDx-Melanoma to help guide improved, risk-aligned care in patients considered low risk by staging (i.e., patients with stage I CM tumors) but who have aggressive molecular tumor biology and may be missed using only staging criteria for prognosis.
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 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Sept. 30, 2023, DecisionDx-Melanoma has been ordered more than 146,000 times for patients diagnosed with cutaneous melanoma.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.
Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning the ability of DecisionDx-Melanoma to (i) provide significantly better risk stratification than AJCC8 staging in patients with stage I CM and (ii) help clinicians and patients obtain more precise information about a patient’s risk of disease progression to inform more personalized, risk-aligned treatment and surveillance management plans. The words “believe,” “can,” “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in this study, including with respect to the discussion of DecisionDx-Melanoma in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended Sept. 30, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.
- Podlipnik S, Martin BJ, Morgan-Linnell SK et al. The 31-gene expression profile test outperforms AJCC in stratifying risk of recurrence in patients with stage I cutaneous melanoma. Cancers. 2024;16(2):287. https://doi.org/10.3390/cancers16020287
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Source: Castle Biosciences Inc.
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