On May 3, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported the publication of an independent, multi-center study in the Archives of Dermatological Research providing a direct chain of evidence that use of DecisionDx-Melanoma test results to guide radiological surveillance could lead to improved patient outcomes (Press release, Castle Biosciences, MAY 3, 2023, View Source [SID1234630957]).1 The study, authored by Dhillon et al., can be found here.
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"Published clinical use data, coupled with improved responses with immunotherapy when the metastatic tumor burden is lower, has previously shown an indirect chain of evidence between the clinical use of our DecisionDx-Melanoma test and improved outcomes due to early detection of metastasis and therefore early treatment intervention," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe this study is significant in that it provides a direct chain of evidence between the use of DecisionDx-Melanoma to guide treatment plan decisions, which could result in improved survival compared to patients from the same institution who did not have their treatment plans informed by our test."
DecisionDx-Melanoma has been validated to inform two clinical decisions in the management of patients with cutaneous melanoma (CM) that are made in the acute post-diagnosis time period:
1) Use of a sentinel lymph node biopsy (SLNB) surgical procedure,2 and
2) The subsequent risk-guided follow-up and management plans that are differentiated between patients who have a high versus a low likelihood of metastasis.3
"In melanoma, as in all cancers, treatment plan decisions are guided by the risk of disease recurrence and metastasis," continued Maetzold. "In this study, the authors controlled for SLNB (all patients underwent the procedure and were negative) and evaluated the impact of implementing risk-guided metastatic surveillance treatment plans for patients with a high-risk DecisionDx-Melanoma test result versus standard of care under the current guidelines. The direct improvement in melanoma-specific survival is what we would expect based upon indirect chain of evidence analyses."
The Dhillon et al. study, conducted at three National Cancer Institute-designated cancer centers, included patients with Stage I or II CM who had a negative SLNB. The experimental group was comprised of patients who had received high-risk DecisionDx-Melanoma test results and thus received routine imaging every six to twelve months. Patients in the control group did not receive DecisionDx-Melanoma testing and had imaging studies driven only by clinical symptoms or physical exam findings.
Key findings of the study include:
Patients in the experimental group who received DecisionDx-Melanoma testing and surveillance imaging had melanoma recurrences detected approximately ten months earlier than patients in the control group (p=0.049).
The average tumor burden detected at patients’ melanoma recurrence was significantly lower in the experimental group compared to the control group (27.6 mm vs. 73.1 mm; p=0.027). Note: recent studies cited in the paper suggest a survival benefit when metastatic melanoma is treated at a lower tumor burden.
Of the patients with a recurrence, 82% in the experimental group and 71% in the control group started immunotherapy.
At patients’ last follow up, 76% of the patients with melanoma recurrence in the experimental group were alive (average follow-up time=45.6 months), compared to 50% of recurrent melanoma patients in the control group (average follow-up time=63.3 months) (p=0.027).
Overall, the study found that using DecisionDx-Melanoma to risk-stratify patients to guide care resulted in earlier detection of melanoma recurrence while the tumor burden was lower, which could lead to improved patient outcomes.
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 Dec. 31, 2022, DecisionDx-Melanoma has been ordered 120,287 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.