Phase Ib trial of IRX-2 plus durvalumab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

OBJECTIVES: IRX-2 is a multi-cytokine immune-activating agent with anti-tumor activity in non-metastatic head and neck squamous cell carcinoma (HNSCC). Here, we evaluated combined IRX-2 and durvalumab in patients with recurrent and/or metastatic HNSCC. MATERIALS AND METHODS: This was a phase Ib trial consisting of dose escalation and expansion. Primary endpoints were safety and biomarkers to assess the immune response in the tumor microenvironment including significant increases in PD-L1 expression and CD8 + tumor infiltrating lymphocytes (TIL) comparing pre- and on-treatment tumor biopsies. Secondary endpoints were objective response rates (ORR) and survival outcomes. RESULTS: Sixteen patients were evaluable for response, and nine patients were evaluable for biomarkers. Thirteen patients (68 %) had exposure to prior anti-PD-1 therapy. No dose-limiting or grade ≥ 3 treatment-related adverse events were observed. On-treatment biopsies showed significantly increased PD-L1 (p = 0.005), CD3+ (p = 0.020), CD4+ (p = 0.022), and CD8 + T cells (p = 0.017) compared to pre-treatment. Median overall survival and progression-free survival (PFS) were 6.18 months (95 % CI, 2.66-8.61) and 2.53 months (95 % CI, 1.81-4.04), respectively. One patient had an objective response (ORR, 5.3 %) with an ongoing PFS of > 25 months. Disease control rate was 42 %. The responder harbored an ARID1A variant of unknown significance (VUS) that was predicted to bind her HLA-I alleles with a higher affinity than the reference peptide. CONCLUSIONS: IRX-2 and durvalumab were safe and elicited the evidence of immune activation in the tumor microenvironment determined by increased PD-L1 expression and CD8+ TILs. CLINICAL TRIAL REGISTRATION NUMBER: NCT03381183.

Interactions between ploidy and resource availability shape clonal interference at initiation and recurrence of glioblastoma.

Glioblastoma (GBM) is the most aggressive form of primary brain tumor. Complete surgical resection of GBM is almost impossible due to the infiltrative nature of the cancer. While no evidence for recent selection events have been found after diagnosis, the selective forces that govern gliomagenesis are strong, shaping the tumor's cell composition during the initial progression to malignancy with late consequences for invasiveness and therapy response. We present a mathematical model that simulates the growth and invasion of a glioma, given its ploidy level and the nature of its brain tissue micro-environment (TME), and use it to make inferences about GBM initiation and response to standard-of-care treatment. We approximate the spatial distribution of resource access in the TME through integration of in-silico modelling, multi-omics data and image analysis of primary and recurrent GBM. In the pre-malignant setting, our in-silico results suggest that low ploidy cancer cells are more resistant to starvation-induced cell death. In the malignant setting, between first and second surgery, simulated tumors with different ploidy compositions progressed at different rates. Whether higher ploidy predicted fast recurrence, however, depended on the TME. Historical data supports this dependence on TME resources, as shown by a significant correlation between the median glucose uptake rates in human tissues and the median ploidy of cancer types that arise in the respective tissues (Spearman r = -0.70; P = 0.026). Taken together our findings suggest that availability of metabolic substrates in the TME drives different cell fate decisions for cancer cells with different ploidy and shapes GBM disease initiation and relapse characteristics.

NTRK3 gene fusion in an adult ganglioglioma: illustrative case.

BACKGROUND: Gangliogliomas are well-differentiated, slow-growing glioneuronal neoplasms frequently reported to harbor upregulating alterations in the mitogen-activated protein kinase pathway, particularly serine-threonine protein kinase B-RAF alterations. Fusions involving neurotrophin tyrosine receptor kinase (NTRK) genes have rarely been reported in ganglioglioma. Similarly, echinoderm microtubule-associated protein-like (EML) 4 gene fusion has been described in lung cancer, but none has been reported in ganglioglioma. OBSERVATIONS: This report discusses the care of a 72-year-old man presenting with medication-refractory, left-sided focal seizures who was found to have a nongadolinium-enhancing, T2-hyperintense, right frontoparietal lesion. The patient received resection, and histological analysis found a World Health Organization grade I ganglioglioma, with genetic analysis demonstrating an EML4-NTRK3 gene fusion protein. LESSONS: To our knowledge, this is the first report of an NTRK3 fusion, EML4-NTRK3, in an adult ganglioglioma, which is otherwise mostly associated with BRAF alterations and activation of the mitogen-activated protein kinase signaling pathway. Further studies are needed to elucidate the function of the resultant fusion protein and determine whether it may serve as a future therapeutic target.

Imaging of the head and neck during the COVID19 pandemic.

There is a wide spectrum of clinical manifestation of COVID-19 in the head and neck, but often these do not have an imaging correlate. This review will highlight the most common imaging features of COVID-19 in the head and neck that can be seen on routine head and neck CT and MRI. In addition, situations where a more dedicated imaging protocol is required will be highlighted. Finally, as mass vaccination efforts are underway worldwide, post vaccination imaging can often complicate cancer surveillance imaging. Post vaccination imaging features and recommendations will be discussed.

Early response dynamics predict treatment failure in patients with recurrent and/or metastatic head and neck squamous cell carcinoma treated with cetuximab and nivolumab.

OBJECTIVES: Recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) is currently an incurable disease. To improve treatment strategies, combinations of cetuximab plus nivolumab or pembrolizumab were evaluated for efficacy and safety for incurable R/M HNSCC. While some patients had a significant clinical benefit with complete or partial response, most patients had stable or progressive disease (PD). To identify patients with a high likelihood of treatment failure and prevent futile treatments, we developed a mathematical model of early response dynamics as an early biomarker of treatment failure. MATERIALS AND METHODS: Demographics, RECIST assessment, and outcome were obtained from patients who were treated with combination of cetuximab and nivolumab on a previously published phase I/II clinical trial. We trained a tumor growth inhibition (TGI) ordinary differential equation (ODE) model describing patient-specific pre-treatment growth rate and uniform initial treatment sensitivity and rate of evolution of resistance. In a leave-one-out approach, we forecasted tumor burden and predicted time to progression (TTP) and PD. RESULTS: The TGI model accurately represented tumor burden dynamics (R2=0.98; RMSE=0.57 cm) and predicted PD with accuracy=0.71,sensitivity=1.00, and specificity=0.69 after three serial response assessment scans. Patient-specific pre-treatment growth rate correlated negatively with TTP (Spearman's ρ=-0.67,p=5.7e-05). CONCLUSION: The TGI model can identify patients with high likelihood of PD based on early dynamics. Further studies including prospective validation are warranted.

Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

PURPOSE: A phase II multi-institutional clinical trial was conducted to determine overall survival (OS) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab and nivolumab. PATIENTS AND METHODS: Patients with R/M HNSCC were treated with cetuximab 500 mg/m2 i.v. on day 14 as a lead-in followed by cetuximab 500 mg/m2 i.v. and nivolumab 240 mg i.v. on day 1 and day 15 of each 28-day cycle. Expression of p16 and programmed cell death-ligand 1 (PD-L1) in archived tumors were determined. Tumor-tissue-modified human papillomavirus (TTMV) DNA was quantified in plasma. RESULTS: Ninety-five patients were enrolled, and 88 patients were evaluable for OS with a median follow-up of 15.9 months. Median OS in the 45 patients who had prior therapy for R/M HNSCC (cohort A) was 11.4 months, with a 1 year OS 50% [90% confidence interval (CI), 0.43-0.57]. Median OS in the 43 patients who had no prior therapy (cohort B) was 20.2 months, with a 1-year OS 66% (90% CI, 0.59-0.71). In the combined cohorts, the p16-negative immunostaining was associated with higher response rate (RR; P = 0.02) but did not impact survival while higher PD-L1 combined positive score was associated with higher RR (P = 0.03) and longer OS (log-rank P = 0.04). In the p16-positive patients, lower median (1,230 copies/mL) TTMV DNA counts were associated with higher RR (P = 0.01) and longer OS compared with higher median (log-rank P = 0.05). CONCLUSIONS: The combination of cetuximab and nivolumab is effective in patients with both previously treated and untreated R/M HNSCC and warrants further evaluation.

Concurrent Cetuximab and Nivolumab as a Second-Line or beyond Treatment of Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results of Phase I/II Study.

We hypothesized the combination of cetuximab and nivolumab would improve survival in recurrent and/or metastatic (R/M) HNSCC by providing synergy in cancer control and evaluated toxicities and efficacy of the combination. Effects of sequential administration of cetuximab and anti-Programmed Cell Death-1 checkpoint inhibitors (CPI) were also explored. Patients who failed at least one line of palliative treatment for incurable HNSCC were treated with cetuximab 500 mg/m2 IV on Day (D)-14 as a lead-in followed by cetuximab 500 mg/m2 IV and nivolumab 240 mg/m2 IV on D1 and D15 every 28-D cycle. Electronic health record-derived real-world data (RWD) were used to explore sequential treatment effects of CPI and cetuximab. A total of 45 evaluable patients were analyzed, and 31/45 (69%) patients had prior exposure to either CPI or cetuximab. The only grade 4 treatment-related adverse event was cetuximab infusion reaction in one patient. The 1-year progression-free survival (PFS) and overall survival (OS) rates were 19% and 44%, respectively. Although patients with no prior CPI (23/45, 51%) showed a trend for more favorable PFS relative to patients with prior CPI (22/45, 49%), the improvement in the 1-year OS did not reach the statistical threshold. For evaluation of sequential CPI and cetuximab treatment effects, we selected RWD-cetuximab cohort with 173 patients and RWD-CPI cohort with 658 patients from 6862 R/M HNSCC. Our result suggested patients treated with RWD-cetuximab after RWD-CPI had worse OS compared to no prior RWD-CPI (HR 1.81, 95% CI 1.02-3.16). Our data suggest the combination of cetuximab and nivolumab is well tolerated. Optimal sequencing of cetuximab and CPI may have an impact in prognosis and requires further evaluation.

Face-to-Face: Resident-led Radiology Medicine Rounds Facilitate Evidence-based Processes for Clinical Decision Support.

BACKGROUND: The transition toward value-based payment models increases focus on the radiologist's direct impact on hospital-provided patient care. Radiology trainees understand inpatient hospital workflows and decision-making paradigms and are well positioned to interface directly with hospital physicians regarding clinical decision making related to diagnostic imaging and/or image guided interventions. A radiology resident-led project with internal medicine residents focused on Clinical Decision Support was designed, implemented, and reviewed, with the objectives of educating clinical teams and positively impacting patient care. MATERIALS AND METHODS: During the 2017-2018 academic year, senior radiology residents (PGY-5) led weekly rounds with medicine residents rotating through inpatient floor units. During these rounds, they discussed indications for and types of hospital inpatient imaging studies, exchanged clinical information, directed further imaging workup, and taught the essentials of image interpretation. Participating medical residents' degree of radiology-awareness and opinions were systematically surveyed at the conclusion of the academic year. Thirty-four out of a total of 161 (21%) Internal Medicine residents responded to the survey. Thirty one percent of these residents could identify an instance where radiology-led rounds altered patient management and 94% acknowledged an increase in medical knowledge. Sixty-one percent believed evidence-based choice for imaging orders was enhanced by attending radiology-led rounds and 64% developed a better understanding of resources available to guide image ordering. Forty-nine percent of residents made suggestions to their Internal Medicine attending physician or more senior trainee or otherwise applied something learned during radiology-led rounds and 42% cancelled or ordered a study based on what they learned or discussed in radiology rounds. Thirty-nine percent of medicine residents stated that these rounds changed their perception of the role of the radiologist and 75% expressed the desire to see increased participation by radiologists in their daily workflow. Radiology resident-led educational medicine rounds promote cross-specialty collaboration, further educate trainees, and directly affect patient management. It is therefore valuable for radiology trainees to directly engage in the teaching of other medical providers, to enhance their own consultative skill set, promote face-to-face interactions with other physicians, and to directly impact patient care.

Occult Nodal Disease and Occult Extranodal Extension in Patients With Oropharyngeal Squamous Cell Carcinoma Undergoing Primary Transoral Robotic Surgery With Neck Dissection.

IMPORTANCE: The historically reported rates of subclinical cervical nodal metastases in oropharyngeal squamous cell carcinoma (OPSCC) predate the emergence of human papillomavirus as the predominant causative agent. The rate of occult nodal disease with changing etiology of OPSCC is not known, and it is challenging to anticipate which patients will be upstaged postoperatively and will require adjuvant therapy. OBJECTIVE: To assess the rate of nodal upstaging and occult extranodal extension (ENE) in a multi-institutional population of patients with pathologic (p)T1-2 OPSCC treated by transoral robotic surgery and neck dissection. DESIGN, SETTING AND PARTICIPANTS: This retrospective, multicenter cohort study of 92 participants at 2 US institutions (Albert Einstein College of Medicine, Bronx, New York [n = 38], and Icahn School of Medicine at Mount Sinai, New York, New York [n = 39]) and 1 Canadian institution (Princess Margaret Hospital, Toronto [n = 15]) examined the rate of postoperative pathologic upstaging for 92 patients with pT1-2 OPSCC undergoing transoral robotic surgery with neck dissection from August 2007 to December 2016. A neuroradiologist at each site blinded to final pathologic diagnosis reviewed preoperative imaging; these findings were compared with operative pathology and applied for tumor staging using the eighth edition of the American Joint Committee on Cancer Cancer Staging Manual. The statistical analysis was performed on December 18, 2018. MAIN OUTCOMES AND MEASURES: Occult pathologic nodal disease and change in nodal category postoperatively. RESULTS: Of 92 patients who met the inclusion criteria, 76 (83%) were male, and they had a mean (SD) age at surgery of 59.5 (10.5) years; 70 patients (84%) with available p16 status were positive. Five of 18 patients (28%) who had no evidence of nodal disease on imaging had occult pathologic nodal disease. Seven of 32 patients (22%) presenting with no nodal disease or with a single metastatic node on imaging received pathologic upstaging because of multiple positive nodes, indicating implementation of additional adjuvant treatment not anticipated after a priori imaging. Changes included 12 patients (13%) who had pathologic nodal upstaging and 12 (13%) with pathologic nodal downstaging in the eighth edition of staging. In the cohort, 24 patients (27%) had pathologic ENE, and 5 of 39 patients (13%) had occult ENE in the absence of radiographic evidence. CONCLUSIONS AND RELEVANCE: Predicting pathologic staging preoperatively for patients with OPSCC undergoing transoral robotic surgery and neck dissection remains a challenge. Although nodal size, tumor size, and location do not help predict ENE, the presence of nodes on imaging and nodal category may help predict ENE. Our findings suggest a small proportion of patients might benefit from further adjuvant therapies not predicted by preoperative imaging based on occult nodal upstaging and ENE.

Occult contralateral nodal disease in oropharyngeal squamous cell carcinoma patients undergoing primary TORS with bilateral neck dissection.

BACKGROUND: Knowledge of the rate of occult contralateral nodal disease for oropharynx cancers (OPSCC) in the era of Human Papillomavirus-dominated disease would inform practitioners as to who may be a candidate for unilateral neck management. The objective of this study was to determine the rate of pathologic contralateral positive nodes in patients in OPSCC patients with pT1 and pT2 disease treated with TORS and bilateral neck dissections (BND). METHODS: Retrospective review of medical records was performed at Princess Margaret Cancer Center, Toronto; Icahn School of Medicine at Mount Sinai, New York City; and Montefiore Medical Center, New York City. Patients with pT1-2 N0-3 (AJCC 8th Edition) OPSCC disease treated with TORS and BND were included. RESULTS: Thirty-two patients met inclusion criteria. Twelve patients (37.5%) had a tonsil primary site, 19 (59.4%) patients had a base of tongue primary site, and 1 (3.1%) patient had a pharyngeal wall primary. Twenty-four (75%) patients were known to be p16+. Twenty-seven patients (84.4%) were radiographically negative in the contralateral neck preoperatively, and two of these patients had pathologic contralateral positive nodes. The occult pathologic contralateral nodal metastasis rate was 7.4% (2/27). The sensitivity, specificity, positive predictive value, and negative predictive value of suspicious contralateral nodes on preoperative imaging for pathologically positive nodes were 33.3%, 86.2%, 20% and 93% respectively. In the p16+ subgroup, the occult nodal positive rate in the contralateral neck was 5%. CONCLUSIONS: pT1-2 OPSCC patients undergoing TORS and elective contralateral neck dissection have a low rate of pathologic contralateral nodal positivity.

Glioblastoma multiforme presenting with an open ring pattern of enhancement on MR imaging.

BACKGROUND: Intracerebral ring enhancing lesions can be the presentation of a variety of pathologies, including neoplasia, inflammation, and autoimmune demyelination. Use of a precise diagnostic algorithm is imperative in correctly treating these lesions and minimizing potential adverse treatment effects. CASE DESCRIPTION: A 55-year-old patient presented to the hospital with complaints of a post-concussive syndrome and a non-focal neurologic exam. Imaging revealed a lesion with an open ring enhancement pattern, minimal surrounding vasogenic edema, and minimal mass effect. Given the minimal mass effect, small size of the lesion, and nonfocal neurological exam, we elected to pursue a comprehensive noninvasive neurologic workup because our differential ranged from inflammatory/infectious to neoplasm. Over the next 8 weeks, the patient's condition worsened, and repeat imaging showed marked enlargement of the lesion with a now closed ring pattern of enhancement with satellite lesions and a magnetic resonance (MR) spectroscopy and perfusion signature suggestive of neoplasm. The patient was taken to surgery for biopsy and debulking of the lesion. Surgical neuropathology examination revealed glioblastoma multiforme. CONCLUSION: The unique open ring enhancement pattern of this lesion on initial imaging is highly specific for a demyelinating process, however, high-grade glial neoplasms can also present with complex and irregular ring enhancement including an open ring sign. Therefore, other imaging modalities should be used, and close follow-up is warranted when the open ring sign is encountered.

Comparison of the Prevalence of Ruptured and Unruptured Cerebral Aneurysms in a Poor Urban Minority Population.

BACKGROUND: Most ruptured cerebral aneurysms are small (<7 mm). Evidence suggests low rupture rates for such lesions (<1% per year). Population studies demonstrate a prevalence rate of 3.2%. This study simultaneously estimates the prevalence of aneurysms in a single geographic population while reporting the observed rate of aneurysmal subarachnoid hemorrhage (aSAH) in the same geographic region composed of a poor urban minority demographic. METHODS: This is an institutional review board-approved, Health Insurance Portability and Accountability Act of 1996-compliant retrospective study performed between 2005 and 2011 at a single center. Part 1 used the electronic medical record to identify all patients with a magnetic resonance angiography demonstrating a cerebral aneurysm. Part 2 used the electronic medical record to identify all patients from the same geographic area presenting with aSAH during the study period. RESULTS: A total of 11,160 subjects had a magnetic resonance angiography from the study area. In this group, 422 intradural cerebral aneurysms were incidentally discovered. Ninety-one percent were less than 10 mm (mean 5.49, standard deviation 4.6). Twenty-one percent were aneurysms of the anterior communicating artery complex. Fourteen percent were of posterior communicating artery origin. A total of 237 patients had aSAH. Ninety-two percent of the aneurysms were less than 10 mm (mean 6 mm, standard deviation 3.2 mm). Both groups were composed of poor urban minority patients. CONCLUSIONS: The observed annual rate of rupture of small anterior circulation aneurysms in this study was .06%-.15% per year. The extrapolated population prevalence of such aneurysms (4.0%-1.5%) may explain the observed rate of rupture of these small aneurysms in a poor urban minority population.

Incidental primary mediastinal choriocarcinoma diagnosed by endobronchial ultrasound-guided fine needle aspiration in a patient presenting with transient ischemic attack and stroke.

We describe a case of a 41-year old male patient with no significant prior medical history who presents with symptoms of Transient Ischemic Attack and stroke. Magnetic Resonance Imaging (MRI) of the brain identified areas of ischemia in the left side, and angiography showed occlusion of the left Medial Cerebral Artery (MCA). Cardiac Transthoracic Echocardiogram (TTE) for stroke evaluation incidentally noted a mediastinal abnormality leading to cancer work-up. Computer Tomography (CT) and 18 F-fluorodeoxyglucose (FDG) PET-CT scan of the chest incidentally revealed an avid 6 cm paraesophagial/subcarinal mass. Further diagnostic work-up with endoscopic and endobronchial ultra sound (EBUS)-guided fine needle aspiration (FNA) of the mass yielded a cytology diagnosis of Germ Cell Tumor (GCT), with choriocarcinoma component. Additionally, high plasma levels of ß-human chorionic gonadotrophin (ß-HCG) were detected with no evidence of testicular tumor. This exceedingly rare presentation for a primary mediastinal choriocarcinoma underscores the importance of complete investigation of young patients presenting with neurological symptoms compatible with ischemic events. Diagn. Cytopathol. 2017;45:738-743. © 2017 Wiley Periodicals, Inc.

Use of computed tomography to assess volume change after endoscopic orbital decompression for Graves' ophthalmopathy.

BACKGROUND: Orbital decompression is frequently performed in the management of patients with sight-threatening and disfiguring Graves' ophthalmopathy. The quantitative measurements of the change in orbital volume after orbital decompression procedures are not definitively known. Furthermore, the quantitative effect of septal deviation on volume change has not been previously analyzed. OBJECTIVES: To provide quantitative measurement of orbital volume change after medial and inferior endoscopic decompression and describe a straightforward method of measuring this change using open-source technologies. A secondary objective was to assess the effect of septal deviation on orbital volume change. METHODS: A retrospective review was performed on all patients undergoing medial and inferior endoscopic orbital decompression for Graves' ophthalmopathy at a tertiary care academic medical center. Pre-operative and post-operative orbital volumes were calculated from computed tomography (CT) data using a semi-automated segmenting technique and Osirix™, an open-source DICOM reader. Data were collected for pre-operative and post-operative orbital volumes, degree of septal deviation, time to follow-up scan, and individual patient Hertel scores. RESULTS: Nine patients (12 orbits) were imaged before and after decompression. Mean pre-operative orbital volume was 26.99 cm(3) (SD=2.86 cm(3)). Mean post-operative volume was 33.07 cm(3) (SD=3.96 cm(3)). The mean change in volume was 6.08 cm(3) (SD=2.31 cm(3)). The mean change in Hertel score was 4.83 (SD=0.75). Regression analysis of change in volume versus follow-up time to imaging indicates that follow-up time to imaging has little effect on change in volume (R=-0.2), and overall mean maximal septal deviation toward the operative side was -0.5mm. Negative values were attributed to deviation away form the operative site. A significant correlation was demonstrated between change in orbital volume and septal deviation distance site (R=0.66), as well as between change in orbital volume and septal deviation angle (R=0.67). Greater volume changes were associated with greater degree of septal deviation away from the surgical site, whereas smaller volume changes were associated with greater degree of septal deviation toward the surgical site. CONCLUSION: A straightforward, semi-automated segmenting technique for measuring change in volume following endoscopic orbital decompression is described. This method proved useful in determining that a mean increase of approximately 6 cm in volume was achieved in this group of patients undergoing medial and inferior orbital decompression. Septal deviation appears to have an effect on the surgical outcome and should be considered during operative planning.

Central venous occlusion mimics carotid cavernous fistula: a case report and review of the literature.

A patient presented with signs and symptoms of a left carotid cavernous fistula (CCF). Computed tomography angiography confirmed filling of the cavernous sinus in the arterial phase. Cerebral digital subtraction angiography demonstrated no evidence of CCF. The workup, diagnosis, and treatment of this patient are discussed, and the literature is reviewed.

Covered stents safely utilized to prevent catastrophic hemorrhage in patients with advanced head and neck malignancy.

PURPOSE: The purpose of this study was to review the use of covered stents in patients with squamous cell carcinoma of the head and neck threatening bilateral neurovascular structures. METHODS: The radiology information system was searched for all patients with bilateral head and neck carcinoma treated with covered stents in the carotid vasculature from 2006 through 2009. Five patients (one woman) of mean age 60.5 years (range 45-69) were identified. All had carotid blowout syndrome after treatment for primary squamous cell carcinoma of the head and neck with subsequent tumor recurrence or metastases immediately threatening bilateral carotid vasculature. Covered stents were placed. Long-term follow-up included clinical progress, verification of stent patency and detection of tumor progression via ultrasound or contrast-enhanced CT after the first month and then every 3-6 months. All patients were maintained on antiplatelet medication after treatment. RESULTS: Covered stents were safely deployed in all patients. Mean survival was 5 months with one outlier surviving for 3 years. There were no subsequent uncontrollable hemorrhages. CONCLUSION: The use of covered stents for avoidance of catastrophic hemorrhage following treatment in patients with head and neck tumors with bilaterally threatened carotid arteries was successful.

Radiofrequency ablation of advanced head and neck cancer.

OBJECTIVE: To determine if the application of radiofrequency ablation to advanced head and neck cancer (HNC) would result in local control of the tumor. DESIGN: Radiofrequency ablation was applied to advanced head and neck malignant tumors in the participants of this nonrandomized controlled trial. SETTING: Academic tertiary care medical center. PARTICIPANTS: Twenty-one participants with recurrent and/or unresectable HNC who failed treatment with surgery, radiation, and/or chemotherapy were selected for the trial. Patients deemed appropriate for curative standard radiation or surgery were not accepted as participants. INTERVENTION: Radiofrequency ablation was applied to head and neck tumors under general anesthesia and computed tomographic scan guidance. MAIN OUTCOME MEASURES: The primary end point was local control. Computed tomographic scan tumor measurements were used to assess response by standard response evaluation criteria in solid tumors (RECIST) guidelines. Secondary outcome measures included survival and quality of life. RESULTS: Eight of 13 participants had stable disease after intervention. Median survival was 127 days, and an improvement in University of Washington quality-of-life scores was noted. Adverse outcomes included 1 death due to carotid hemorrhage and 2 strokes. CONCLUSION: Radiofrequency ablation is a palliative treatment alternative that shows promise in addressing the challenges of local control and quality of life in patients with incurable HNC who have failed standard curative treatment.

External validation of the New Orleans Criteria (NOC), the Canadian CT Head Rule (CCHR) and the National Emergency X-Radiography Utilization Study II (NEXUS II) for CT scanning in pediatric patients with minor head injury in a non-trauma center.

BACKGROUND: Head CT scans are considered the imaging modality of choice to screen patients with head trauma for neurocranial injuries; however, widespread CT imaging is not recommended and much research has been conducted to establish objective clinical predictors of intracranial injury (ICI) in order to optimize the use of neuroimaging in children with minor head trauma. OBJECTIVE: To evaluate whether a strict application of the New Orleans Criteria (NOC), Canadian CT Head Rule (CCHR) and National Emergency X-Radiography Utilization Study II (NEXUS II) in pediatric patients with head trauma presenting to a non-trauma center (level II) could reduce the number of cranial CT scans performed without missing clinically significant ICI. MATERIALS AND METHODS: We conducted an IRB-approved retrospective analysis of pediatric patients with head trauma who received a cranial CT scan between Jan. 1, 2001, and Sept. 1, 2008, and identified which patients would have required a scan based on the criteria of the above listed decision instruments. We then determined the sensitivities, specificities and negative predictive values of these aids. RESULTS: In our cohort of 2,101 patients, 92 (4.4%) had positive head CT findings. The sensitivities for the NOC, CCHR and NEXUS II were 96.7% (95%CI 93.1-100), 65.2% (95%CI 55.5-74.9) and 78.3% (95%CI 69.9-86.7), respectively, and their negative predictive values were 98.7%, 97.6% and 97.2%, respectively. In contrast, the specificities for these aids were 11.2% (95%CI 9.8-12.6), 64.2% (95%CI 62.1-66.3) and 34.2% (95%CI 32.1-36.3), respectively. Therefore, in our population it would have been possible to scan at least 10.9% fewer patients. CONCLUSIONS: The number of cranial CT scans conducted in our pediatric cohort with head trauma would have been reduced had any of the three clinical decision aids been applied. Therefore, we recommend that further validation and adoption of pediatric head CT decision aids in non-trauma centers be considered to ultimately increase patient safety while reducing medical expense.