Cytology-based Cancer Surgery of the Head and Neck (CyCaS-HN): a prospective, randomized, controlled clinical trial

Abstract

Purpose Liquid-based cytology (LBC) is routinely used in gynecology but is rarely applied in head and neck oncology though many suspicious lesions are easily accessible. While several studies have evaluated the potential use of LBC for early detection and molecular characterization of head and neck squamous cell carcinomas (HNSCCs), no study investigated its potential role in surgical management and therapy planning so far. Methods Twenty-fve patients with cT1-2 squamous cell carcinomas of the oral cavity and oropharynx were prospectively enrolled in this study and were randomized to two treatment arms: in the control arm, a diagnostic panendoscopy with incisional biopsy was followed by a second operation with transoral tumor resection±neck dissection and tracheostomy. In the intervention arm, patients underwent LBC diagnostics and in case of a positive result received one single operation with panendoscopy and incisional biopsy for confrmation of LBC result by rapid section histology followed by transoral tumor resection±neck dissection and tracheostomy in the same session. Results Time between clinical diagnosis and defnitive surgical treatment was signifcantly shorter in the intervention group compared with the control group (p<0.0001). Additionally, time of hospitalization (p<0.0001) and cumulative operation time (p=0.062) were shorter in the intervention group. No signifcant diferences in overall, progression-free, and diseasespecifc survival were observed. Conclusion Cytology-based cancer surgery is a promising therapeutic strategy that can potentially be considered for a well-defned group of early-stage HNSCC patients and help to avoid repetitive general anesthesia, shorten the diagnosis-totreatment interval and spare operation as well as hospitalization time.