2ABSTRACT PURPOSE Radiotherapy induced xerostomia (RIX) is the most common permanent side effect of radiotherapy (RT) to the head and neck (H&N). There is no effective topical treatment. LMS-611 is a mimetic of a natural lamellar body which prevents thick secretions like saliva from congesting organs. Primary objective -assess saliva properties before and during RT to the H&N. Secondary objectives -re-assess saliva properties with the addition of LMS-611, measure inter-patient variability, correlate patient reported symptoms with laboratory measurements and design subsequent first-in-human clinical trial of LMS-611. METHODS Patients with H&N cancer receiving RT as primary treatment were recruited. Patients completed the Groningen RIX (GRIX) questionnaire and provided saliva samples at baseline, weeks 2, 4 and 6 of RT. Saliva adhesiveness and viscosity was tested by measuring time taken to travel 5cm down an inclined plane. RESULTS 30 patients were enrolled. The inclined plane test (IPT) results (seconds) were as follows: baseline 31.3, week-2: 49.7, week-4: 51.1, week-6: 55.7. Wide inter-patient variability was seen at baseline. GRIX scores increased as RT progressed. Spearman rank correlation coefficient of inclined plane tests with GRIX scores was -0.06 at baseline, week-2 0.25, week-4 0.12 and week-6 0.08. LMS-611 concentrations of 10mg/ml and 20mg/ml significantly reduced IPT times on saliva samples. CONCLUSIONS Saliva becomes more visco-adhesive and RIX worsens as RT progresses. There is little correlation between objective and subjective measures of RIX. The addition of LMS611to thick, sticky saliva restores its fluidity ex-vivo. This warrants in-vivo analysis of the effect of LMS-611 upon RIX.

Enlighten-Research publications by members of the University of Glasgow http://eprints.gla.ac.uk TITLE: Radiotherapy induced xerostomia: a randomised, double-blind, controlled trial of Visco-ease oral spray versus placebo in head and neck cancer patients

This review explores how human papillomavirus-related oropharyngeal cancer affects health-related quality of life (HR-QoL) and the role patient-reported outcomes (PROs) can play in optimizing treatment. PRO measures (PROMs) are comprehensive, subjective assessments of patients' day-to-day HR-QoL. Developed through a scientifically robust, multistage process, PROMs offer insight into patients' symptoms, function, and satisfaction with care. The use of PROMs can increase symptom awareness, stimulate discussion, and enhance shared decision-making between patients and healthcare providers. K E Y W O R D S oropharyngeal cancer, patient reported outcomes 1 | INTRODUCTION Improved understanding of both the biology and the treatment of head and neck cancers, specifically the excellent outcomes in virally induced human papillomavirus (HPV)-related oropharyngeal cancer (OPC), has highlighted the importance of health-related quality of life (HR-QoL) measurements in clinical practice and research settings. While maintaining excellent oncologic outcomes remains the priority of patient care, understanding, and optimizing short-and long-term HR-QoL outcomes are essential to guide patient management, inform the design of clinical trials, and for outcome monitoring. 1Given its favorable prognosis and the younger demographic affected by HPV-related OPC compared with non-HPV-related OPC, there has been increasing interest in HR-QoL outcomes. Research and clinical trials have shifted toward studying how to de-escalate therapy for these patients to reduce the short-and long-term toxicity of therapy and preserve function. [2][3][4] Studies in this area, therefore, require a focus on HR-QoL to confirm that any proposed treatment approach not only maintains oncologic outcomes but also improves HR-QoL. As such, integration of patient-reported outcomes measures (PROMs) as standard of care in daily clinical practice could have a profound impact on patients with HPV-related OPC. This review explores the rationale for HR-QoL measures in HPV-related OPC, the methods used to measure HR-QoL, novel strategies to integrate PROMs into clinical care, HR-QoL data reported in clinical trials to date, and the future applications of PROMs in HPV-related OPC. Specifically, we will demonstrate the central role PROMs should play in the study and management of patients with HPV-related OPC.

Objectives Sinonasal and skull base tumors are rare, making it difficult to identify trends in surgical outcome. This study examines complications in a large cohort of patients undergoing surgery for sinonasal malignancy. Methods Following IRB approval, an institutional database was reviewed to identify patients who underwent surgery for sinonasal or skull base malignancies from 1973 to 2016 at our institution. Charlson comorbidity index score and Clavien–Dindo grade were calculated. The main study endpoint was subgroup analysis of Clavien–Dindo Grade 0, Grades 1–2, and Grades 3–5 complications. An ordinal logistic regression model was constructed to assess the association between comorbidities, demographics, tumor characteristics, and surgical complications. Results In total, 448 patients met inclusion criteria. Perioperative mortality rate at 30 days was 1.6% (n = 7). The rate of severe complications (Clavien–Dindo 3 or higher) was 13.6% (n = 61). Multivariate analysis using an ordinal logistic regression model showed no association between Charlson comorbidity index score and Clavien–Dindo grade of postoperative complication. Advanced T‐stage was significantly associated with complications (p = 0.0014; odds ratio: 3.442 [95% confidence interval: 1.615, 7.338]). Conclusion Surgery for sinonasal and skull base tumors is safe with a low mortality rate. Advanced T‐stage is associated with postoperative complications. These findings have implications for preoperative risk stratification. Key Points Surgery for sinonasal malignancy is safe with a 30 mortality of 1.6% and rate of severe complications of 12.8%. There is no association between patient comorbidity and post operative complication. On multivariate analysis, only advanced T stage was associated with increased rate of surgical complication.

No abstract