Real-World Evidence Shows Clinicians Appropriately Use the Prognostic 40-Gene Expression Profile (40-GEP) Test for High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) Patients

Hooper, Perry B.; Farberg, Aaron S.; Fitzgerald, Alison L.; Siegel, Jennifer J.; Rackley, Briana B; Prasai, Anesh; Kurley, Sarah J.; Goldberg, Matthew S.; Litchman, Graham

doi:10.1080/07357907.2022.2116454

Cited by 7 publications

(15 citation statements)

References 44 publications

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“…These clinical treatment plan actions are not surprising given that GEP tests have been widely used and advocated for as riskstratification factors that influence treatment plans in various cancer types. [38][39][40][41][42][43][44][45][46][47] Specifically, the results described here and within Hooper et al, 36 mirror those of other risk-stratification gene expression profile tests (Table 4). For example, for stage I-II, 41 The 23-GEP test demonstrated that within the cohort of patients with low/intermediate risk lung nodules, 25% had a change in management plan from invasive procedure to surveillance when receiving a negative 23-GEP result.…”

Section: Resultssupporting

confidence: 63%

“…The real-world clinical use population for 40-GEP testing (Hooper, et al,. 36 ) does align with the UTILISE population both by number of risk factors and in percent of patients ≥65 years old (data presented here and Castle Biosciences data on file). While the focus of this analysis was on decision making pre-and post-40 GEP results a limitation to this prospective study is that a formal assessment of patient outcomes could not be performed due to abbreviated follow-up time for both cohorts.…”

Section: Resultssupporting

confidence: 55%

“…This analysis of the prospective UTILISE study demonstrates the positive impact of 40-GEP test results on clinician recommendations and actions for management of their Medicare-eligible highrisk cSCC patients. Hooper, et al, 36 identified that the 40-GEP test had a significant impact on clinician decision making in a real-world setting, particularly for those ≥65 years of age. This data led us to analyze the impact on treatment plans within the Medicareeligible population in the prospective UTILISE study.…”

Section: Resultsmentioning

confidence: 99%

“…Exclusion Criteria Patient is willing and able to provide informed consent. Direct employees and family members of an Investigator Newly diagnosed cSCC with no more than six months before patient consent, with pathologically confirmed invasive cSCC for whom the clinician has determined the 40-GEP to be clinically appropriate (as previously described 36 ) and will order the Five clinical sites and eleven unique clinicians have enrolled patients qualifying for inclusion in the current analyses. Eight (72%) clinicians were board certified dermatologists (with an average/median practice time of 21.6 years) of which seven identified as Mohs surgeons, and three were dermatologybased physician assistants who had been practicing in dermatology for an average of 3.3 years.…”

Section: Inclusion Criteriamentioning

confidence: 99%

“…32 Further, several studies have demonstrated that use of the 40-GEP test results impacted management decisions in a clinically and statistically significant and risk-appropriate manner for high-risk cSCC patient scenarios. [33][34][35][36] The overarching goal of this ongoing, multicenter, prospective Clinical Utility and Health Outcomes Study (UTILISE) is to demonstrate patterns of test utilization, the distribution of results across clinicopathologic variables, and the impact on clinician recommendations for clinical management of high-risk cSCC patients. This analysis focuses on the Medicare-eligible, clinically tested population to evaluate the utility of 40-GEP results on clinician recommendations regarding therapeutic management for their high-risk cSCC patients.…”

mentioning

confidence: 99%

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A Prospective, Multi-Center Clinical Utility Study Demonstrates That the 40-Gene Expression Profile (40-GEP) Test Impacts Clinical Management for Medicare-Eligible Patients with High-Risk Cutaneous Squamous Cell Carcinoma (cSCC)

Saleeby

Bielinski

Fitzgerald³

et al. 2022

J of Skin

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The incidence and mortality rates of cutaneous squamous cell carcinoma (cSCC) in the Medicare population are rapidly increasing. The current national guidelines are broad and the available staging systems for stratification are inadequate to accurately guide patient management. A prognostic 40-gene expression profile (40-GEP) test has demonstrated both analytical and clinical validity for assessment of metastatic risk of high-risk cSCC patients independent of traditional clinicopathologic factors. Real-world data have shown that clinicians can identify appropriate patients for 40-GEP testing and use this personalized, molecular risk stratification tool to guide risk-aligned clinical planning and patient management. The data herein focuses on 59 Medicare-eligible patients (≥65 years of age) enrolled within a multicenter, prospective Clinical Utility and Health Outcomes Study (UTILISE) conducted to demonstrate patterns of 40-GEP test utilization, distribution of results across clinicopathologic variables, and impact on clinician recommendations for clinical management of high-risk cSCC patients. Of patients under study, more than 80% of clinicians reported that the 40-GEP had a positive impact toward managing their high-risk SCC patient, 42% stated, a 40-GEP test result was the single most influential factor in determining management plans and 24% made changes to their treatment plan in after receiving the 40-GEP result‑ a clinical actionability rate comparable to those of currently covered molecular tests for cancer patients. This analysis demonstrates the positive impact the 40-GEP is having on clinicians’ assessment of risk for their high-risk cSCC patients, which, in line with guidelines, is driving risk-aligned changes in treatment plans.

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Section: Resultssupporting

confidence: 63%

Section: Resultssupporting

confidence: 55%

Section: Resultsmentioning

confidence: 99%

Section: Inclusion Criteriamentioning

confidence: 99%

mentioning

confidence: 99%

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A Prospective, Multi-Center Clinical Utility Study Demonstrates That the 40-Gene Expression Profile (40-GEP) Test Impacts Clinical Management for Medicare-Eligible Patients with High-Risk Cutaneous Squamous Cell Carcinoma (cSCC)

Saleeby

Bielinski

Fitzgerald³

et al. 2022

J of Skin

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Integrating the 40-Gene Expression Profile (40-GEP) Test Improves Metastatic Risk-Stratification Within Clinically Relevant Subgroups of High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) Patients

Wysong,

Somani,

Ibrahim

et al. 2024

Dermatol Ther (Heidelb)

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Introduction The validated 40-gene expression profile (40-GEP) test independently stratifies risk of regional or distant metastasis for cutaneous squamous cell carcinoma (cSCC) tumors with high-risk clinicopathologic features. This study evaluated the stratification of risk by the 40-GEP test in a large cohort of tumors with one or more high-risk factors and in clinically relevant subgroups, including tumors within National Comprehensive Cancer Network (NCCN) high- and very-high-risk groups, lower-stage BWH T1 and T2a tumors, and patients > 65 years old. Methods This multicenter ( n = 58) performance study of the 40-GEP included 897 patients. Kaplan-Meier analyses were performed to assess risk stratification profiles for 40-GEP Class 1 (low), Class 2A (higher) and Class 2B (highest) risk groups, while nested Cox regression models were used to compare risk prediction of clinicopathologic risk classification systems versus risk classification systems in combination with 40-GEP. Results Patients classified as 40-GEP Class 1, Class 2A, or Class 2B had significantly different metastatic risk profiles ( p < 0.0001). Integrating 40-GEP results into models with individual clinicopathologic risk factors or risk classification systems (Brigham and Women’s Hospital, American Joint Committee on Cancer Staging Manual, 8th Edition) and NCCN demonstrated significant improvement in accuracy for prediction of metastatic events (ANOVA for model deviance, p < 0.0001 for all models). Conclusion The 40-GEP test demonstrates accurate, independent, clinically actionable stratification of metastatic risk and improves predictive accuracy when integrated into risk classification systems. The improved accuracy of risk assessment when including tumor biology via the 40-GEP test ensures more risk-aligned, personalized patient management decisions. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-024-01111-5.

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Inconsistent Associations Between Risk Factor Profiles and Adjuvant Radiation Therapy (ART) Treatment in Patients with Cutaneous Squamous Cell Carcinoma and Utility of the 40-Gene Expression Profile to Refine ART Guidance

Moody,

Farberg,

Somani

et al. 2024

Dermatol Ther (Heidelb)

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Introduction National Comprehensive Cancer Network (NCCN) recommendations for adjuvant radiation therapy (ART) use are similar for High Risk and Very High Risk cutaneous squamous cell carcinoma (cSCC) with negative post-surgical margins. Although studies report reductions in disease progression following ART treatment, ART use is likely inconsistent when guided by available risk factors. This study evaluated the association of ART with clinical risk factors in ART-treated and untreated patients and showed the clinical utility of the 40-gene expression profile (40-GEP) for guiding ART. Methods A multicenter study of 954 patients was conducted with institutional review board (IRB) approval. The 40-GEP test was performed using primary tumor tissue from patients with either a minimum of 3 years of follow-up or a documented regional or distant metastasis. Unsupervised hierarchical cluster analysis identified patterns of clinical risk factors for ART-treated patients, then identified untreated patients with matching risk factor profiles. Results were cross-referenced to 40-GEP test results to determine utility of the test to guide ART. Results Analysis demonstrated inconsistent implementation of ART for eligible patients. Cluster analysis identified four patient profiles based on clusters of risk factors and, notably, matching profiles in ART-treated and untreated patients. Further, the analysis identified patients who received but could have deferred ART on the basis of 40-GEP test result and biologically low risk of metastasis, and untreated patients who likely would have benefitted from ART on the basis of their 40-GEP test result. Conclusions ART guidance is not determined by the presence of specific clinicopathologic factors, with treated and untreated patients sharing the same risk factor profiles. cSCC risk determination based on NCCN recommendations for clinical factor assessment results in inconsistent use of ART. Including tumor biology-based prognostic information from the 40-GEP refines risk and identifies patients who are most appropriate and likely to benefit from ART, and those that can consider deferring ART.

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Real-World Evidence Shows Clinicians Appropriately Use the Prognostic 40-Gene Expression Profile (40-GEP) Test for High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) Patients

Cited by 7 publications

References 44 publications

A Prospective, Multi-Center Clinical Utility Study Demonstrates That the 40-Gene Expression Profile (40-GEP) Test Impacts Clinical Management for Medicare-Eligible Patients with High-Risk Cutaneous Squamous Cell Carcinoma (cSCC)

A Prospective, Multi-Center Clinical Utility Study Demonstrates That the 40-Gene Expression Profile (40-GEP) Test Impacts Clinical Management for Medicare-Eligible Patients with High-Risk Cutaneous Squamous Cell Carcinoma (cSCC)

Integrating the 40-Gene Expression Profile (40-GEP) Test Improves Metastatic Risk-Stratification Within Clinically Relevant Subgroups of High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) Patients

Inconsistent Associations Between Risk Factor Profiles and Adjuvant Radiation Therapy (ART) Treatment in Patients with Cutaneous Squamous Cell Carcinoma and Utility of the 40-Gene Expression Profile to Refine ART Guidance

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