Browsing by Author "Newman, Jason G."

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    Advanced head and neck surgery training during the COVID-19 pandemic
    (Wiley, 2020) Givi, Babak; Moore, Michael G.; Bewley, Arnaud F.; Coffey, Charles S.; Cohen, Marc A.; Hessel, Amy C.; Jalisi, Scharukh; Kang, Steven; Newman, Jason G.; Puscas, Liana; Shindo, Maisie; Shuman, Andrew; Thakkar, Punam; Weed, Donald T.; Chalian, Ara; Otolaryngology -- Head and Neck Surgery, School of Medicine
    The COVID-19 pandemic has significantly impacted medical training. Here we assess its effect on head and neck surgical education. Methods Surveys were sent to current accredited program directors and trainees to assess the impact of COVID-19 on the fellow's experience and employment search. Current fellows' operative logs were compared with those of the 2018 to 2019 graduates. Results Despite reduction in operative volume, 82% of current American Head and Neck Society fellows have reached the number of major surgical operations to support certification. When surveyed, 86% of program directors deemed their fellow ready to enter practice. The majority of fellows felt prepared to practice ablative (96%), and microvascular surgery (73%), and 57% have secured employment to follow graduation. Five (10%) had a pending job position put on hold due to the pandemic. Conclusions Despite the impact of the COVID-19 pandemic, current accredited trainees remain well-positioned to obtain proficiency and enter the work-force.
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    Advanced head and neck surgery training during the COVID-19 pandemic
    (Wiley, 2020) Givi, Babak; Moore, Michael G.; Bewley, Arnaud F.; Coffey, Charles S.; Cohen, Marc A.; Hessel, Amy C.; Jalisi, Scharukh; Kang, Steven; Newman, Jason G.; Puscas, Liana; Shindo, Maisie; Shuman, Andrew; Thakkar, Punam; Weed, Donald T.; Chalian, Ara; Otolaryngology -- Head and Neck Surgery, School of Medicine
    Background The COVID-19 pandemic has significantly impacted medical training. Here we assess its effect on head and neck surgical education. Methods Surveys were sent to current accredited program directors and trainees to assess the impact of COVID-19 on the fellow's experience and employment search. Current fellows' operative logs were compared with those of the 2018 to 2019 graduates. Results Despite reduction in operative volume, 82% of current American Head and Neck Society fellows have reached the number of major surgical operations to support certification. When surveyed, 86% of program directors deemed their fellow ready to enter practice. The majority of fellows felt prepared to practice ablative (96%), and microvascular surgery (73%), and 57% have secured employment to follow graduation. Five (10%) had a pending job position put on hold due to the pandemic. Conclusions Despite the impact of the COVID-19 pandemic, current accredited trainees remain well-positioned to obtain proficiency and enter the work-force.
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    Early, precise, and safe clinical evaluation of the pharmacodynamic effects of novel agents in the intact human tumor microenvironment
    (Frontiers Media, 2024-04-12) Gundle, Kenneth R.; Rajasekaran, Karthik; Houlton, Jeffrey; Deutsch, Gary B.; Ow, Thomas J.; Maki, Robert G.; Pang, John; Nathan, Cherie-Ann O.; Clayburgh, Daniel; Newman, Jason G.; Brinkmann, Elyse; Wagner, Michael J.; Pollack, Seth M.; Thompson, Matthew J.; Li, Ryan J.; Mehta, Vikas; Schiff, Bradley A.; Wenig, Barry I.; Swiecicki, Paul L.; Tang, Alice L.; Davis, Jessica L.; van Zante, Annemieke; Bertout, Jessica A.; Jenkins, Wendy; Turner, Atticus; Grenley, Marc; Burns, Connor; Frazier, Jason P.; Merrell, Angela; Sottero, Kimberly H. W.; Derry, Jonathan M. J.; Gillespie, Kate C.; Mills, Bre; Klinghoffer, Richard A.; Pathology and Laboratory Medicine, School of Medicine
    Introduction: Drug development is systemically inefficient. Research and development costs for novel therapeutics average hundreds of millions to billions of dollars, with the overall likelihood of approval estimated to be as low as 6.7% for oncology drugs. Over half of these failures are due to a lack of drug efficacy. This pervasive and repeated low rate of success exemplifies how preclinical models fail to adequately replicate the complexity and heterogeneity of human cancer. Therefore, new methods of evaluation, early in the development trajectory, are essential both to rule-in and rule-out novel agents with more rigor and speed, but also to spare clinical trial patients from the potentially toxic sequelae (high risk) of testing investigational agents that have a low likelihood of producing a response (low benefit). Methods: The clinical in vivo oncology (CIVO®) platform was designed to change this drug development paradigm. CIVO precisely delivers microdose quantities of up to 8 drugs or combinations directly into patient tumors 4–96 h prior to planned surgical resection. Resected tissue is then analyzed for responses at each site of intratumoral drug exposure. Results: To date, CIVO has been used safely in 6 clinical trials, including 68 subjects, with 5 investigational and 17 approved agents. Resected tissues were analyzed initially using immunohistochemistry and in situ hybridization assays (115 biomarkers). As technology advanced, the platform was paired with spatial biology analysis platforms, to successfully track anti-neoplastic and immune-modulating activity of the injected agents in the intact tumor microenvironment. Discussion: Herein we provide a report of the use of CIVO technology in patients, a depiction of the robust analysis methods enabled by this platform, and a description of the operational and regulatory mechanisms used to deploy this approach in synergistic partnership with pharmaceutical partners. We further detail how use of the CIVO platform is a clinically safe and scientifically precise alternative or complement to preclinical efficacy modeling, with outputs that inform, streamline, and de-risk drug development.
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    Gene expression profiling for metastatic risk in head and neck cutaneous squamous cell carcinoma
    (Wiley, 2022-01-06) Arron, Sarah T.; Wysong, Ashley; Hall, Mary A.; Bailey, Christine N.; Covington, Kyle R.; Kurley, Sarah J.; Goldberg, Matthew S.; Kasprzak, Julia M.; Somani, Ally-Khan; Ibrahim, Sherrif F.; Brodland, David G.; Cleaver, Nathan J.; Maher, Ian A.; Xia, Yang; Koyfman, Shlomo A.; Newman, Jason G.; Dermatology, School of Medicine
    Objective: Over 50% of newly diagnosed cutaneous squamous cell carcinoma (cSCC) lesions occur in the head and neck (cSCC-HN), and metastasis to nodal basins in this region further complicates surgical and adjuvant treatment. The current study addressed whether the 40-gene expression profile (40-GEP) test can predict metastatic risk in cSCC-HN with improved accuracy and provide independent prognostic value to complement current risk assessment methods. Study design: Multicenter, retrospective cohort study. Methods: Formalin-fixed paraffin-embedded primary tumor tissue and associated clinical data from patients with cSCC-HN (n = 278) were collected from 33 independent centers. Samples were analyzed via the 40-GEP test. Cases were staged per American Joint Committee on Cancer, Eighth Edition (AJCC8) and Brigham and Women's Hospital (BWH) criteria after comprehensive medical record and pathology report review. Metastasis-free survival (MFS) rates were determined, and risk factors were analyzed via Cox regression. Results: The 40-GEP test classified the cohort into low (Class 1, n = 126; 45.3%), moderate (Class 2A, n = 134; 48.2%), and high (Class 2B, n = 18; 6.5%) metastatic risk at 3 years postdiagnosis. Regional/distant metastasis occurred in 54 patients (19.4%). MFS rates were 92.1% (Class 1), 76.1% (Class 2A), and 44.4% (Class 2B; p < .0001). Multivariate analysis of 40-GEP results with AJCC8 or BWH tumor stage, or clinicopathologic risk factors, demonstrated independent prognostic value of the 40-GEP test (p < .03). Accuracy of predicting metastatic risk was also improved using 40-GEP classification (p < .02). Conclusions: Improved metastatic risk stratification through the 40-GEP test could complement cSCC-HN risk assessment for better-informed decision-making for treatment and surveillance and ultimately improve patient outcomes.
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    Validation of a 40-Gene Expression Profile Test to Predict Metastatic Risk in Localized High-Risk Cutaneous Squamous Cell Carcinoma
    (Elsevier, 2020) Wysong, Ashley; Newman, Jason G.; Covington, Kyle R.; Kurley, Sarah J.; Ibrahim, Sherrif F.; Farberg, Aaron S.; Bar, Anna; Cleaver, Nathan J.; Somani, Ally-Khan; Panther, David; Brodland, David G.; Zitelli, John; Toyohara, Jennifer; Maher, Ian A.; Xia, Yang; Bibee, Kristin; Griego, Robert; Rigel, Darrell S.; Plasseraud, Kristen Meldi; Estrada, Sarah; Sholl, Lauren Meldi; Johnson, Clare; Cook, Robert W.; Schmults, Chrysalyne D.; Arron, Sarah T.; Dermatology, School of Medicine
    Background: Current staging systems for cutaneous squamous cell carcinoma (cSCC) have limited positive predictive value (PPV) for identifying patients who will experience metastasis. Objective: To develop and validate a gene expression profile (GEP) test for predicting risk for metastasis in localized, high-risk cSCC with the goal of improving risk-directed patient management. Methods: Archival formalin-fixed paraffin-embedded primary cSCC tissue and clinicopathologic data (n=586) were collected from 23 independent centers in a prospectively designed study. A GEP signature was developed using a discovery cohort (n=202) and validated in a separate, non-overlaping, independent cohort (n=324). Results: A prognostic, 40-gene expression profile (40-GEP) test was developed and validated, stratifying high-risk cSCC patients into classes based on metastasis risk: Class 1 (low-risk), Class 2A (high-risk), and Class 2B (highest-risk). For the validation cohort, 3-year metastasis-free survival (MFS) rates were 91.4%, 80.6%, and 44.0%, respectively. A PPV of 60% was achieved for the highest-risk group (Class 2B), an improvement over staging systems; while negative predictive value, sensitivity, and specificity were comparable to staging systems. Limitations: Potential understaging of cases could affect metastasis rate accuracy.Conclusion: The 40-GEP test is an independent predictor of metastatic risk that can complement current staging systems for patients with high-risk cSCC.