Faculty Bibliography

We propose a reference architecture aimed at supporting the safety and security of medical devices. The ISOSCELES (Intrinsically Secure, Open, and Safe Cyber-Physically Enabled, Life-Critical Essential Services) architecture is justified by a collection of design principles that leverage recent advances in software component isolation based on hypervisor and other separation technologies. The instantiation of the architecture for particular medical devices is supported by a development process based on Architecture Analysis and Design Language. The architecture models support safety and security analysis as part of a broader risk management framework. The models also can be used to derive skeletons of the device software and to configure the platform's separation policies and an extensive set of services. We are developing prototypes of the architecture and example medical device instantiations on low-cost boards that can be used in product solutions. The prototype and supporting development and assurance artifacts are being released under an open-source license.

BACKGROUND:Pathologic extracapsular extension (pECE) in metastatic lymph nodes is associated with poor prognosis for oropharyngeal carcinoma. The prognostic value of radiographic extracapsular extension (rECE) has not been studied. METHODS:A retrospective analysis was conducted of 111 patients with locally advanced oropharyngeal carcinoma treated in the Mount Sinai Radiation Oncology Department with accessible pretreatment CT reports. Univariate Kaplan-Meier and multivariate Cox regression analyses compared cohorts for locoregional control, distant control, progression-free (PFS), and overall survival (OS). RESULTS:Sixty-four patients had rECE-present and 47 had rECE-absent scans. The patients with rECE presence had significantly worse OS (3-year: 95% vs 77%; p = .006), PFS (3-year: 91% vs 71%; p = .002), and distant control (3-year: 98% vs 81%; p = .008), with no difference in locoregional control. On multivariate analysis, rECE-presence was a negative prognosticator for OS, PFS, and distant control. CONCLUSION/CONCLUSIONS:This study suggests that rECE is an independent prognosticator of poor distant control and survival with little impact on locoregional control for oropharyngeal carcinoma.

OBJECTIVES/OBJECTIVE:Overall treatment package time (from surgery to radiotherapy [RT] completion) > 100 days can portend poor outcomes in head and neck cancer. Faster postoperative recovery seen with transoral robotic surgery may decrease treatment duration and toxicity for adjuvant RT and chemoradiation. METHODS:We retrospectively reviewed all patients treated with transoral robotic surgery (n = 124) and adjuvant RT and chemoradiation (n = 33) at our institution for head and neck cancer from April 2007 to December 2011 to determine treatment duration, acute toxicity, and long-term percutaneous gastric tube rates. RESULTS:The median overall treatment time was 86 days and from surgery to RT start was 41 days; median RT duration was 44 days. No wound breakdown or infection occurred during or after RT. Two-year actuarial locoregional control, distant metastasis-free survival, and overall survival rates were 93%, 96%, and 97%, respectively. CONCLUSIONS:Adjuvant RT after transoral robotic surgery for head and neck cancer can be completed safely and in a timely fashion. Longer follow-up and a larger cohort will be needed to determine if this regimen is more effective than traditional surgery followed by adjuvant RT.