Transoral robotic surgery using the Da Vinci Xi: an update of a prospective outcome analysis

Background: The Da Vinci Xi-system is not FDA-approved for transoral robotic surgery (TORS), resulting in limited data. Methods: In this single-center prospective study, 90 head and neck cancer patients were consecutively included. The primary objective was to evaluate the safety and feasibility of TORS performed with the Xi-robot, with the rate of safe/successful Xi-TORS surgeries (adequate exposure with complete macroscopical resection and absence of death/unforeseen tracheotomy within 72 h) serving as the primary endpoint. Results: Overall, 79 (87.7%) patients were scheduled for primary TORS, while the remaining 11 (12.3%) were scheduled for local recurrence/second primary after radio(chemo)therapy (salvage setting). Tumors were predominantly oropharyngeal (n = 44, 48.9%) and carcinomas of unknown primary (CUP) (n = 35, 38.9%). The most common histology was squamous cell carcinoma (SCC) (n = 83, 92.2%). Tumor stage (UICC 8th ed.) distribution was I (48.9%), II (21.1%), III (10.0%), and IV (21.1%). The success rate (primary endpoint) was 96.7%. Intraoperative difficulties and complications were encountered in 42.0% and 17.0% of patients, respectively. Postoperative hemorrhage at the TORS site occurred in 9.1%. No treatment-related deaths were encountered. Adjuvant radiation (RT) and chemoradiation (CRT) in the primary TORS group was indicated in 31.2% and 23.4% of patients, respectively. Two-year overall survival (OS) and disease-specific survival (DSS) in the SCC group was 87.6% and 93.2%, respectively. P16-positivity was a positive prognosticator for OS, DSS, and locoregional recurrence-free survival (LRFS) in the primary oropharyngeal SCC group but not in the CUP-group. No long-term tracheotomies were necessary; 4 patients (4.5%) needed long-term jejunostomy/gastrostomy tube feeding. In the total patient population, functional baseline level (assessed by FOIS score and MD Anderson Dysphagia Inventory) was regained 24 months postoperatively, and quality of life (assessed by QLQ-H&N35 questionnaires) recuperated 1 year postoperatively. The subgroup of patients treated primarily with TORS alone showed quicker functional recovery than the patients treated with TORS + RT/CRT. Conclusions: Xi-TORS is safe, feasible, and yields excellent oncological/functional outcomes.