Essential data variables for a minimum dataset for head and neck cancer trials and clinical research: HNCIG consensus recommendations and database.

The Head and Neck Cancer International Group (HNCIG) has undertaken an international modified Delphi process to reach consensus on the essential data variables to be included in a minimum database for HNC research. Endorsed by 19 research organisations representing 34 countries, these recommendations provide the framework to facilitate and harmonise data collection and sharing for HNC research. These variables have also been incorporated into a ready to use downloadable HNCIG minimum database, available from the HNCIG website.

Surgical management of low-risk papillary thyroid cancer in real life in Spain: a nationwide survey of endocrine neck surgeons and endocrinologists.

BACKGROUND: The extent of surgery in patients with papillary thyroid cancer (PTC) is a subject of ongoing debate. We aimed to explore the attitude of Spanish specialists (endocrinologists, surgeons, and otolaryngologists) in real life on the surgical management of low-risk PTC. METHODS: We designed an anonymous, web-based survey to inquire information regarding the preferences of interviewees for hemithyroidectomy (Hem), total thyroidectomy (TT) and prophylactic central neck dissection (pCND) in one standard patient with PTC and six clinical variants. We differentiated between small (1.1-2.5 cm) and large (2.6-4.0 cm) tumors. RESULTS: A total of 278 valid responses were received and divided into two groups: group END (n = 135) and group SUR (n = 143, 101 general surgeons and 42 otolaryngologists). The preference for Hem was low in the standard patient and similar between both groups (40.6 vs 49.0%, NS). This preference decreased for tumors measuring 2.6-4.0 cm, multifocal, with risk location, family history of thyroid cancer, or history of irradiation, and increased in patients older than 65 years or with comorbidity. Preference for pCND ranged from 12.6-71.1% in the group END and from 22.4-65.0% in the group SUR, with few differences between the two. In multivariate analysis, being a high-volume specialist was associated with a lower preference for Hem, while having private practice was associated with a more favorable opinion of Hem. CONCLUSION: The real clinical practice of Spanish specialists is far from what is recommended by the clinical guidelines in patients with low-risk PTC, especially among high-volume professionals.

The observational clinical registry (cohort design) of the European Reference Network on Rare Adult Solid Cancers: The protocol for the rare head and neck cancers.

INTRODUCTION: Care for head and neck cancers is complex in particular for the rare ones. Knowledge is limited and histological heterogeneity adds complexity to the rarity. There is a wide consensus that to support clinical research on rare cancer, clinical registries should be developed within networks specializing in rare cancers. In the EU, a unique opportunity is provided by the European Reference Networks (ERN). The ERN EURACAN is dedicated to rare adults solid cancers, here we present the protocol of the EURACAN registry on rare head and neck cancers (ClinicalTrials.gov Identifier: NCT05483374). STUDY DESIGN: Registry-based cohort study including only people with rare head and neck cancers. OBJECTIVES: to help describe the natural history of rare head and neck cancers;to evaluate factors that influence prognosis;to assess treatment effectiveness;to measure indicators of quality of care. METHODS: Settings and participants It is an hospital based registry established in hospitals with expertise in head and neck cancers. Only adult patients with epithelial tumours of nasopharynx; nasal cavity and paranasal sinuses; salivary gland cancer in large and small salivary glands; and middle ear will be included in the registry. This registry won't select a sample of patients. Each patient in the facility who meets the above mentioned inclusion criteria will be followed prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. It is a secondary use of data which will be collected from the clinical records. The data collected for the registry will not entail further examinations or admissions to the facility and/or additional appointments to those normally provided for the patient follow-up. Variables Data will be collected on patient characteristics (eg. patient demographics, lifestyle, medical history, health status); exposure data (eg. disease, procedures, treatments of interest) and outcomes (e.g. survival, progression, progression-free survival, etc.). In addition, data on potential confounders (e.g. comorbidity; functional status etc.) will be also collected. Statistical methods The data analyses will include descriptive statistics showing patterns of patients' and cancers' variables and indicators describing the quality of care. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause specific mortality will be used to determine independent predictors of overall survival, recurrence etc. Variables to include in the multivariable regression model will be selected based on the results of univariable analysis. The role of confounding or effect modifiers will be evaluated using stratified analysis or sensitivity analysis. To assess treatment effectiveness, multivariable models with propensity score adjustment and progression-free survival will be performed. Adequate statistical (eg. marginal structural model) methods will be used if time-varying treatments/confounders and confounding by indication (selective prescribing) will be present. RESULTS: The registry initiated recruiting in May 2022. The estimated completion date is December 2030 upon agreement on the achievement of all the registry objectives. As of October 2022, the registry is recruiting. There will be a risk of limited representativeness due to the hospital-based nature of the registry and to the fact that hospital contributing to the registry are expert centres for these rare cancers. Clinical Follow-up could also be an issue but active search of the life status of the patients will be guaranteed.

COVID-19 Pandemic and its Impact on the Management of Head and Neck Cancer in the Spanish Healthcare System.

Introduction Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has represented a major challenge for healthcare systems worldwide, changing the habits of physicians. A reorganization of healthcare activity has been necessary, limiting surgical activity to essential cases (emergencies and oncology), and improving the distribution of health resources. Objective To analyze the impact of the COVID-19 pandemic on head and neck cancer surgery management in Spain. Methods A cross-sectional study, through an anonymous and voluntary online survey distributed to 76 Spanish otorhinolaryngology departments. Results A total of 44 centers completed the survey, 65.9% of which were high-volume. A total of 45.5% of them had to stop high-priority surgery and 54.5% of head and neck surgeons were relocated outside their scope of practice. Surgeons reported not feeling safe during their usual practice, with a decrease to a 25% of airway procedures. A total of 29.5% were "forced" to deviate from the "standard of care" due to the epidemiological situation. Conclusions Approximately half of the departments decreased their activity, not treating their patients on a regular basis, and surgeons were reassigned to other tasks. It seems necessary that the head and neck surgeons balance infection risk with patient care. The consequences of the reported delays and changes in daily practice should be evaluated in the future in order to understand the real impact of the pandemic on the survival of head and neck cancer patients.

[Is microvascular density an independent prognostic factor in squamous cell carcinoma of the tongue?]. / El la densidad microvascular un factor pronóstico independiente en el carcinoma epidermoide de lengua?

BACKGROUND: The relationship between tumour angiogenesis and prognosis in head and neck squamous cell carcinomas remains controversial in the literature. This study was designed to determine the role of tumour vascularization in tongue squamous cell carcinoma behaviour. MATERIAL AND METHOD: Tumour vascularization was evaluated in 43 patients with primary squamous cell carcinomas of the tongue. Anti-endothelial cell antigen (CD31) was used to stain the specimens. The correlation between tumour vascularization and both survival rate and tumour recurrence was established to determine the prognostic value of microvessel density (Cox proportional-hazards survival regression). RESULTS: Adequate staining was achieved in all specimens with anti-CD31. Mean microvessel density was 30.6 (x400 field), and the median was 27. After a 5-year follow-up, a local, regional, or distant recurrence of the tumour occurred in 29 patients (67.4 %). Twenty patients (46.5 %) were alive with or without tumour, while 23 patients (53.5 %) had died due to tumour recurrence. Statistical analysis failed to demonstrate any correlation between microvessel density and 5-year survival (P = .59) and recurrence rate (P = .31). CONCLUSIONS: Despite the controversy, these results suggest that microvascular density is not a valid independent prognostic indicator in patients with squamous cell carcinoma of the tongue.

¿El la densidad microvascular un factor pronóstico independiente en el carcinoma epidermoide de lengua? / Is microvascular density an independent prognostic factor in squamous cell carcinoma of the tongue?

Objetivos: La relación entre angiogénesis tumoral y el pronóstico en carcinomas epidermoides de cabeza y cuello continúa en controversia. Se ha diseñado este estudio para determinar el papel de la vascularización tumoral en el comportamiento de los carcinomas epidermoides de lengua. Material y método: Se ha evaluado la vascularización tumoral en 43 pacientes con carcinoma epidermoide de lengua. Se emplearon anticuerpos antiendoteliales (CD31) para teñir las muestras. Para determinar el valor pronóstico de la microvascularización tumoral, se comparó la densidad microvascular con el índice de recidiva y la supervivencia (test de regresión de Cox). Resultados: Todas las muestras se tiñeron adecuadamente mediante anti-CD31. La densidad vascular media fue 30,6 (en campos x400) y la mediana, 27. Tras un seguimiento de 5 años, en 29 (67,4 %) pacientes se iniciaron recidivas local, regional o a distancia; 20 (46,5 %) permanecían vivos con o sin tumor, mientras que 23 (53 %) habían fallecido por una recidiva tumoral. El análisis estadístico no ha demostrado ninguna relación significativa de la densidad microvascular con la supervivencia a 5 años (p = 0,59) ni con el riesgo de recidiva a los 5 años (p = 0,31). Conclusiones: Aunque hay controversias, estos resultados indican que la densidad microvascular no es un indicador pronóstico independiente y válido en pacientes con carcinoma epidermoide de lengua

Background: The relationship between tumour angiogenesis and prognosis in head and neck squamous cell carcinomas remains controversial in the literature. This study was designed to determine the role of tumour vascularization in tongue squamous cell carcinoma behaviour. Material and method: Tumour vascularization was evaluated in 43 patients with primary squamous cell carcinomas of the tongue. Anti-endothelial cell antigen (CD31) was used to stain the specimens. The correlation between tumour vascularization and both survival rate and tumour recurrence was established to determine the prognostic value of microvessel density (Cox proportional-hazards survival regression). Results: Adequate staining was achieved in all specimens with anti-CD31. Mean microvessel density was 30.6 (x400 field), and the median was 27. After a 5-year follow-up, a local, regional, or distant recurrence of the tumour occurred in 29 patients (67.4 %). Twenty patients (46.5 %) were alive with or without tumour, while 23 patients (53.5 %) had died due to tumour recurrence. Statistical analysis failed to demonstrate any correlation between microvessel density and 5-year survival (P = .59) and recurrence rate (P = .31). Conclusions: Despite the controversy, these results suggest that microvascular density is not a valid independent prognostic indicator in patients with squamous cell carcinoma of the tongue