Nutritional status and post-operative complications in patients undergoing surgery for advanced pharyngeal or laryngeal cancer.

PURPOSE: Malnutrition is an important prognostic indicator of post-operative outcomes in patients undergoing surgery for head and neck cancer, however, limited studies utilize validated nutrition assessment tools to accurately assess risk. The aim of this study was to determine the relationship between nutritional status on post-operative complications and length of stay for patients undergoing either a laryngectomy, pharyngectomy or pharyngolaryngectomy for head and neck cancer. METHODS: Patients with head and neck cancer undergoing a laryngectomy, pharyngectomy or pharyngolaryngectomy at a tertiary hospital in Australia were eligible for this retrospective cohort study (n = 40). Nutritional status was assessed by the dietitian on admission using the validated Subjective Global Assessment tool. Clinical outcomes were collected via retrospective chart review and included length of stay and post-operative complications. RESULTS: Pre-operative malnutrition incidence was 40%. Malnourished patients had higher incidences of any type of complication (57% vs 44%, p = 0.013) and pressure injury (86% vs 14%, p = 0.011) compared to well-nourished patients. Well-nourished patients had a clinically important shorter median length of stay compared to malnourished patients (17.5 vs 20 days). CONCLUSION: Early identification and management of malnutrition is essential to minimize risk of post-operative complications and reduce length of stay and should be considered a key component of prehabilitation programs.

An AAV-based, room-temperature-stable, single-dose COVID-19 vaccine provides durable immunogenicity and protection in non-human primates.

The SARS-CoV-2 pandemic has affected more than 185 million people worldwide resulting in over 4 million deaths. To contain the pandemic, there is a continued need for safe vaccines that provide durable protection at low and scalable doses and can be deployed easily. Here, AAVCOVID-1, an adeno-associated viral (AAV), spike-gene-based vaccine candidate demonstrates potent immunogenicity in mouse and non-human primates following a single injection and confers complete protection from SARS-CoV-2 challenge in macaques. Peak neutralizing antibody titers are sustained at 1 year and complemented by functional memory T cell responses. The AAVCOVID vector has no relevant pre-existing immunity in humans and does not elicit cross-reactivity to common AAVs used in gene therapy. Vector genome persistence and expression wanes following injection. The single low-dose requirement, high-yield manufacturability, and 1-month stability for storage at room temperature may make this technology well suited to support effective immunization campaigns for emerging pathogens on a global scale.

Immunogenicity of an AAV-based, room-temperature stable, single dose COVID-19 vaccine in mice and non-human primates.

The SARS-CoV-2 pandemic has affected more than 70 million people worldwide and resulted in over 1.5 million deaths. A broad deployment of effective immunization campaigns to achieve population immunity at global scale will depend on the biological and logistical attributes of the vaccine. Here, two adeno-associated viral (AAV)-based vaccine candidates demonstrate potent immunogenicity in mouse and nonhuman primates following a single injection. Peak neutralizing antibody titers remain sustained at 5 months and are complemented by functional memory T-cells responses. The AAVrh32.33 capsid of the AAVCOVID vaccine is an engineered AAV to which no relevant pre-existing immunity exists in humans. Moreover, the vaccine is stable at room temperature for at least one month and is produced at high yields using established commercial manufacturing processes in the gene therapy industry. Thus, this methodology holds as a very promising single dose, thermostable vaccine platform well-suited to address emerging pathogens on a global scale.

Volatile organic compound breath testing detects in-situ squamous cell carcinoma of bronchial and laryngeal regions and shows distinct profiles of each tumour.

Volatile organic compound (VOC) breath testing of lung and head and neck squamous cell carcinoma (SCC) has been widely studied, however little is known regarding VOC profiles of in-situ SCC. A prospective study of VOC in patients with histologically proven SCC, either in-situ or advanced, and controls. Breath samples were analysed using the E-nose Cyranose ®320 and by gas chromatography/mass spectroscopy. Predictive models were developed using bootstrap forest using all 32 sensors. Data from 55 participants was analysed: 42 SCC cases comprising 20 bronchial (10 in-situ, 10 advanced) and 22 laryngeal (12 in-situ, 10 advanced), and 13 controls. There were 32 (76%) male SCC cases with mean age 63.6 (SD = 9.5) compared with 11 (85%) male controls with mean age 61.9 (SD = 10.1). Predictive models for in situ cases had good sensitivity and specificity compared to controls (overall, 95% and 69%; laryngeal, 100% and 85%; bronchial, 77% and 80%). When distinguishing in-situ and advanced tumours, sensitivity and specificity 82% and 75% respectively. For different tumour types (bronchial versus advanced laryngeal) sensitivity and specificity were 100% and 80% respectively. VOCs isolated from in-situ cancers included some previously demonstrated in advanced cancers and some novel VOCs. In-situ bronchial and laryngeal cancer can be detected by VOC analysis. Distinction from normal controls and between the two tumour types could allow screening in high risk groups for these curable lesions.

Defining the low-risk salvage laryngectomy-A single-center retrospective analysis of pharyngocutaneous fistula.

OBJECTIVES: Salvage total laryngectomies (STL) are not a homogeneous group. Most will fall into two groups: i) Patients with previous AJCC stage I/II larynx cancer who have had radiotherapy to the larynx only (STL-LOR), or ii) Patients who have had previous AJCC stage III/IV larynx cancer and subsequent radiotherapy to the larynx and draining nodal basins with concurrent cisplatin chemotherapy (STL-CRT). We aimed to compare PCF rates following STL in these two groups. METHODS: A retrospective review of the department's cohort between January 2010 and August 2015 was conducted. RESULTS: Seventy-seven patients underwent total laryngectomy for larynx cancer between January 2010 and August 2015. There were 10 post-laryngectomy fistulas (13.0%). Three of these occurred in the 38 patients undergoing primary total laryngectomy (PTL), and seven in the 39 patients undergoing STL, rates of 7.9% and 17.9%, respectively. Twenty-two patients had received radiation to the larynx alone without chemotherapy (STL-LOR) for initial Stage I/II disease. Eleven patients had received laryngeal and neck irradiation plus cisplatin chemotherapy (STL-CRT) for initial stage III/IV disease. Of the 22 STL-LOR patients, two developed PCF (9.1%). Of the 11 STL-CRT patients, five developed PCF. There was no difference in the rate of PCF between PTL and STL-LOR. There was a statistically significant increase in PCF in STL-CRT versus PTL (p = .009) and in PCF in STL-CRT versus STL-LOR (p = .027). CONCLUSION: Salvage laryngectomies are often treated as a homogenous group. We demonstrate that PCF rates vary significantly depending on preoperative radiation fields and the use of chemotherapy. LEVEL OF EVIDENCE: 2b.

Improving guideline sensitivity and specificity for the identification of proactive gastrostomy placement in patients with head and neck cancer.

BACKGROUND: Swallowing and nutrition guidelines for patients with head and neck cancer are available for identification of proactive gastrostomy placement in patients with high nutritional risk. The purpose of this study was to investigate improvements to the validity of these guidelines. METHODS: A multivariate analysis was fitted to the original dataset (n = 501) to examine the variables that may predict gastrostomy placement (eg, tumor site, treatment, sex, and age). Using these factors, the high risk category was modified and retrospectively validated in the same cohort to provide new measures of sensitivity and specificity. RESULTS: The following were positive predictors of gastrostomy placement: T3 (p = .01), T4 (p < .001), and chemoradiotherapy (p < .001). Laryngeal (p = .02) and skin cancer (p < .001) were negative predictors. Modification of the high risk definition improved sensitivity to 58% and maintained specificity at 92%. CONCLUSION: Minor modifications to the high risk definition in the guidelines have improved the guideline sensitivity for future use. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1163-E1171, 2016.

Decreased hospital stay and significant cost savings after routine use of prophylactic gastrostomy for high-risk patients with head and neck cancer receiving chemoradiotherapy at a tertiary cancer institution.

BACKGROUND: Evidence-based nutritional and swallowing guidelines were developed to identify patients at high risk of developing malnutrition during chemoradiation for head and neck cancer. These guidelines recommended a prophylactic gastrostomy and were actively implemented at our institution in January 2007. This study assesses the effect of this policy change on patient outcomes. METHODS: This retrospective cohort study was carried out for the years before (2005) and after (2007) implementation of these guidelines. RESULTS: In all, 165 patients were treated with radical chemoradiation for head and neck cancer at our institution in the years 2005 and 2007. Gastrostomy tube complications were low. Patients in 2007 had significantly fewer hospital admissions, unexpected admissions, and a shorter mean duration of hospital stay in comparison with those in 2005. CONCLUSIONS: Prophylactic gastrostomy tubes in patients with high-risk head and neck cancer resulted in a significant decrease in hospital admissions and length of stay, and led to increased bed availability.

High specificity of combined narrow band imaging and autofluorescence mucosal assessment of patients with head and neck cancer.

BACKGROUND: The purpose of this study was to evaluate combined autofluorescence (AF) and narrow band imaging (NBI) for detection of mucosal lesions additional to known primary head and neck cancers and to determine impact on management. METHODS: Patients with head and neck cancer requiring preoperative screening or posttreatment surveillance had white light (WL), AF and NBI inspection of the head and neck and bronchus. Known primary cancers were not analyzed, only additional lesions. Moderate dysplasia or worse was considered significant. RESULTS: In all, 73 patients were recruited. Respectively, there were 24 and 18 additional lesions in the head and neck and bronchus that had significant histopathology. In both regions, AF and NBI were more sensitive than WL for detecting significant dysplasia with NBI demonstrating better specificity than AF (p = .003); 11 of 73 patients (15.1%) had additional findings detected by AF and NBI, which had an impact on management. CONCLUSION: Combined AF and NBI inspection is highly specific at panendoscopy and can influence management.

MedlinePlus-based health information prescriptions: a comparison of email vs paper delivery.

BACKGROUND: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health information prescriptions (HIPs) can be effectively integrated into clinic workflow, but compliance to visit health information sites such as MedlinePlus is limited. OBJECTIVE: Compare the efficacy of paper (pHIP) and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs. METHOD: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information. Survey non-responders were contacted by telephone to determine the reasons for no response. RESULTS: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most (82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites. CONCLUSIONS: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes.

Autofluorescence improves pretreatment mucosal assessment in head and neck cancer patients.

OBJECTIVE: Panendoscopy is used in selected patients with head and neck cancer to detect second primary disease. We hypothesized that adding autofluorescence to the bronchoscopy and laryngoscopy part of this procedure could add to the detection of clinically meaningful dysplasias and carcinomas in both the head and neck and bronchus, with resultant change in management. STUDY DESIGN: Prospective observational study on consecutive patients with head and neck cancer who had panendoscopy prior to surgery. SETTING: Teaching hospital, tertiary referral center. SUBJECTS AND METHODS: All patients had white-light inspection observed by ENT surgeons, followed by autofluorescence inspection of the head and neck tumor and surrounding area as well as the bronchus. Extra biopsies were taken from regions of abnormal fluorescence where there was no white-light abnormality. RESULTS: Sixty-six patients were studied; mean age 64.9 +/- 11 years. As a result of autofluorescence, 33 mucosal biopsies were taken from the head and neck and 37 from the bronchus. Histology included three carcinoma in situ lesions and four severe dysplasias. As a result of these autofluorescence biopsies, change of management occurred in four patients (6% of the total patients). Standard panendoscopy changed management in five patients. Therefore, standard panendoscopy led to change in management in only 55 percent of cases (CI 21%-86%, P = 0.02), with the rest detected by autofluorescence. CONCLUSION: Adding autofluorescence to panendoscopy in patients with head and neck cancer changed management in a clinically significant number of patients.

DAFE autofluorescence assessment of oral cavity, larynx and bronchus in head and neck cancer patients.

Head and neck (H&N) cancer patients have a high incidence of local field change as well as second primary lung tumours. We have applied the Wolf Diagnostic Autofluorescence Endoscopy (DAFE) system in a novel way, combining autofluorescence evaluation of both H&N region and bronchial. New H&N cases as well as "old" cases with symptoms were included. The DAFE procedure was done separate to panendoscopy. The H&N region was examined first; images were recorded of the known primary with reference to subsequent resection margins, as well as of adjacent mucosa inspecting for additional abnormal sites. Then autofluorescence bronchoscopy was performed. Changes in management were only on the basis of histology taken because of abnormal autofluorescence. One hundred and seven cases were referred, including 96 new cases and 11 old cases. Autofluorescence examination of H&N detected sites which led to change of management in 11 patients. This included additional sites in nine patients (which then either had extra surgery or radiotherapy as a result) and wider resection margins were made possible in two patients. In the bronchus there were 21 significant lesions in 16 patients. Immediate management change occurred in one invasive cancer, two microinvasive carcinomas and three carcinomas in situ (in four patients). There were 15 sites of severe and moderate dysplasia in 12 patients. None of these bronchoscopic lesions were detectable on CT chest. Therefore, overall an immediate change in management occurred in 15 of 107 patients (14% of patients). This combined procedure yielded a significant number of lesions particularly as a simple addition to preoperative work-up in new H&N cancer cases.