Functional outcomes of immunotherapy induction treatment and transoral robotic surgery therapeutic approach for oropharyngeal squamous cell carcinoma: an intervention study based on a prospective cohort

Abstract

Background Therapeutic approach of locally advanced oropharyngeal squamous cell carcinoma (SCC) is based in treatment strategies which result in poor functional outcomes, mainly in distinct grades of dysphagia, leading to impaired quality of life for these patients. Therefore, minimally invasive surgeries, like transoral robotic surgery (TORS), are been used to achieve less postoperative morbidity. Moreover, there is an increasing interest in induction treatment strategies, such immunotherapy, which might play a role in achieving less intensive primary surgeries. Objective The aim of this study is to analyse if in the therapeutic approach of locoregional advanced SCC of the oropharynx, immunotherapy as an induction treatment together with TORS can obtain an improvement in functional outcomes, with the same adequacy of surgical margins and local control of disease, compared with current treatment strategies. Design A multicentre non-randomized intervention study based on a prospective cohort will be carried out during 9 years and 11 months at Hospital Universitari de Girona Doctor Josep Trueta (Girona), Hospital Germans Trias i Pujol (Badalona) and Hospital Universitari de Bellvitge (L'Hospitalet de Llobregat). Methods Using a non-probabilistic consecutive sampling, patients who have had histologically confirmation of SCC of the oropharynx, in a locally advanced stage, with surgical indication, who express biomarkers to undergo immunotherapy induction treatment and meet all other inclusion and exclusion criteria will be recruited to perform this study. To do so, 216 patients will be assigned into two groups. Intervention group will receive immunotherapy induction treatment followed by TORS. Control group will receive conventional treatment (TORS). Both groups will be followed up in order to assess functional outcomes, mainly the grade of dysphagia by functional videoendoscopy. The main dependent variable, the grade of dysphagia, will be categorized by: absence or minor defect, and major defect. Once categorized, a logistic regression on the intervention’s variable controlling all covariates will be estimated