The consensus guidelines were drafted by a
multidisciplinary panel of radiation oncologists and
dermatologists/Mohs micrographic surgeons with expertise in
cutaneous squamous cell carcinoma (SCC) management; they provide a
recommended framework for using DecisionDx-SCC testing with
American Joint Committee on Cancer 8th Edition (AJCC8) staging to
guide decisions regarding the use of adjuvant radiation therapy
(ART) in patients with high-risk SCC to control disease
progression1
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of an expert consensus article in the
Journal of Clinical and Aesthetic Dermatology (JCAD) related to the
utility of its DecisionDx-SCC test in clinical decision-making
regarding the use of ART.2 The consensus guidelines outline a
recommended risk-based workflow that integrates DecisionDx-SCC and
AJCC8 staging into current National Comprehensive Cancer Network®
(NCCN) guidelines to improve precision in ART recommendations based
on which patients are at the highest risk for metastasis and most
likely to benefit from treatment.
“ART is recommended by evidence-based guidelines to reduce the
risk of recurrence in patients with high-risk SCC,” said Ramesh
Gopal, M.D., Ph.D., lead author, radiation oncologist and associate
professor of radiation oncology at the New Mexico Comprehensive
Cancer Center in Albuquerque, New Mexico. “While the presence of
perineural invasion (PNI) will typically trigger a conversation
about whether to consider ART, the guidelines vary in their
interpretation of which SCC patients should be considered for the
treatment, which can carry a risk of side-effects for the patient
and costs for our healthcare system.”
The expert panel convened in June 2023 to review validation and
real-world data for the DecisionDx-SCC test and to discuss their
experiences, rationales and scenarios in which they have used the
test to improve risk stratification and more accurately identify
SCC patients at high risk of metastasis who may benefit from ART.
The panel identified gaps in current clinical practice where the
DecisionDx-SCC test has utility in guiding treatment decisions,
including its use regarding:
- Escalation of care for lower-stage patients with high-risk
tumors,
- De-escalation of care for patients for whom the risks of ART
may outweigh the benefits, and
- Decision-making regarding elective radiation to the nodal
basin.
Based on these gaps, the panel developed risk-based clinical
recommendations and a workflow for ART referral in patients with
SCC, which can be viewed in the JCAD article. The workflow
integrates DecisionDx-SCC testing, which analyzes a patient’s tumor
biology to independently predict risk of nodal or distant
metastasis, and AJCC8 staging, which is based on a patient’s
clinicopathologic risk factors, into current NCCN guidelines with a
goal of improving precision in ART recommendations in the SCC
patient population.
“As a panel, we agreed that the process used today to route SCC
patients for ART can be improved, and DecisionDx-SCC can be a
determining factor in the next step for management of high-risk
SCC,” added Gaurav Singh, M.D., MPH, consensus panel member, and
board-certified dermatologist, Mohs surgeon and assistant professor
of dermatology in Wisconsin. “The test provides independent
risk-stratification that can augment existing risk prediction
systems, including AJCC8 and Brigham and Women’s Hospital (BWH)
staging, to inform these important decisions with greater accuracy
and ensure ART is brought to patients with the highest risk of
disease progression who are most likely to benefit from treatment.
DecisionDx-SCC can also help validate the decision to avoid
radiation in seemingly high-risk tumors that are in fact low risk
based on genetic profile.”
Specific consensus recommendations and statements outlined in
the article include the following:
- A DecisionDx-SCC Class 2A or 2B result, indicating a higher or
highest risk of metastasis, in each AJCC8 tumor stage serves as a
high- or very high-risk feature for consideration in recommending
ART.
- The increased metastatic risk conferred by a Class 2A or 2B
result in multivariate analysis (hazard ratio=2.3, p=0.013; and
hazard ratio=6.9, p<0.001, respectively) is similar or higher
than that conferred by other high-risk clinicopathologic features,
including PNI and poor differentiation.
- Patients at the highest risk of metastasis, as indicated by a
DecisionDx-SCC Class 2B test result, should be referred to
radiation oncology with a recommendation for a multidisciplinary
tumor board discussion.
- In nuanced discussions where the risks associated with ART may
outweigh the benefits, the additional information provided by the
DecisionDx-SCC test can assist in personalized
decision-making.
- The DecisionDx-SCC test can help radiation oncologists
determine a more precise risk-benefit ratio for elective nodal
radiation.
- The panel recommended stronger consideration of elective nodal
radiation for a DecisionDx-SCC Class 2B tumor, given the
dramatically increased risk of nodal metastasis.
Overall, the panel agreed the DecisionDx-SCC test provides
independent risk stratification that, when combined with
traditional staging and management guidelines, enhances the
clinical picture, allowing clinicians to more accurately identify
SCC patients who are most likely to benefit from ART, as well as
lower-risk patients who would benefit less from treatment. In a
validation study of the DecisionDx-SCC test by Wysong et al.,
metastatic risk prediction of AJCC8 and BWH staging systems was
significantly improved when DecisionDx-SCC test results were
included.3 As supported by the consensus article, the objective,
independent risk stratification provided by the test can improve
precision in multidisciplinary treatment recommendations, such as
the use of ART, which could save the U.S. healthcare system
hundreds of millions of dollars through more appropriate use of the
treatment.4
About DecisionDx®-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an
individual patient’s tumor biology to predict individual risk of
cutaneous squamous cell carcinoma metastasis for patients with one
or more 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. Peer-reviewed publications have
demonstrated that DecisionDx-SCC is an independent predictor of
metastatic risk and that integrating DecisionDx-SCC with current
prognostic methods can add positive predictive value to clinician
decisions regarding staging and management.
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, DiffDx-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 the
DecisionDx-SCC test to (i) improve risk stratification and more
accurately identify SCC patients at high risk of metastasis who may
benefit from ART, (ii) provide independent risk stratification
that, when combined with traditional staging and management
guidelines, allows clinicians to more accurately identify SCC
patients who are most likely to benefit from ART, as well as
lower-risk patients who would benefit less from treatment and (iii)
save our healthcare system hundreds of millions of dollars through
more appropriate use of ART. The words “can,” “potential” 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
recommendations and guidelines presented in this report, 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 Annual Report on Form 10-K for
the year ended December 31, 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.
- The authors of the consensus report and members of the
multidisciplinary panel include the following physicians: Ramesh
Gopal, M.D., Ph.D., a radiation oncologist and Associate
Professor of Radiation Oncology at the New Mexico Comprehensive
Cancer Center, in Albuquerque, New Mexico; Michael Marquardt,
M.D., MPH, a radiation oncologist at Hall-Perrine Cancer
Center, in Cedar Rapids, Iowa; Gaurav Singh, M.D., MPH, a
board-certified dermatologist and Mohs surgeon in Wisconsin;
Stanislav N. Tolkachjov, M.D., a board-certified
dermatologist and Mohs micrographic and reconstructive surgeon at
Epiphany Dermatology in Lewisville, Texas, Clinical Assistant
Professor at the Department of Dermatology at University of Texas
at Southwestern in Dallas, Texas, Clinical Associate Professor at
the Texas A&M School of Medicine in Dallas, Texas, and a core
faculty for the dermatology residency at Baylor University Medical
Center in Dallas, Texas; Sarah T. Arron, M.D., Ph.D., a
board-certified dermatologist and Mohs micrographic and
reconstructive surgeon at Peninsula Dermatology Medical Group in
Burlingame, California.
- Gopal R, Marquardt M, Singh G, et al. Integrating 40-GEP
Testing to Improve Clinical Recommendations for Adjuvant Radiation
for Cutaneous Squamous Cell Carcinoma: Multidisciplinary Consensus
Guidelines. J Clin Aesthet Dermatol. 2024;17(3 Suppl 2):S3–S8.
- Wysong A, Newman JG, Covington KR, et al. Validation of a
40-gene expression profile test to predict metastatic risk in
localized high-risk cutaneous squamous cell carcinoma. J Am Acad
Dermatol. 2021;84(2):361–369.
- Somani SK, Ibrahim SF, Tassavor M, et al. Use of the 40-gene
expression profile (40-gep) test in Medicare-eligible patients
diagnosed with cutaneous squamous cell carcinoma (cSCC) to guide
adjuvant radiation therapy (ART) decisions leads to a significant
reduction in healthcare costs. J Clin Aesthet Dermatol.
2024;17(1):41–44.
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version on businesswire.com: https://www.businesswire.com/news/home/20240319013541/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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