LIHNCS: Lugol’s Iodine in Head and Neck Cancer Surgery—A multi-centre, randomised, controlled trial assessing the effectiveness of Lugol’s Iodine to assist excision of moderate dysplasia, severe dysplasia and carcinoma in-situ at mucosal resection margin of oral and oropharyngeal squamous cell carcinoma.

Abstract

6065 Background: Oral cavity and oropharynx cancer are increasing worldwide but survival has not significantly improved over the last thirty years. Presence of dysplasia or carcinoma in-situ at surgical margins following resection of squamous carcinoma (SCC) of the head and neck is associated with increased local recurrence and reduced survival. While carcinoma can usually be distinguished from normal mucosa, dysplasia is less readily distinguished at operation. We describe outcomes of LIHNCS, a RCT assessing effectiveness of Lugol’s iodine staining for visualization and excision of margin dysplasia at primary surgery. Methods: Patients planned for curative surgical resection of oral cavity/ oropharynx SCC were recruited. Participants were randomised 1:1 into either a standard surgical treatment arm or surgical treatment including Lugol’s iodine staining according to defined SOP. Randomisation was stratified by centre and surgeon using computer-generated random permuted blocks. Data monitors, pathologists and external reviewers were blinded to treatment allocations. Chief investigator, surgeons and other health care professionals were blinded to results. Primary endpoint is presence of carcinoma or dysplasia at mucosal margins. Results: Sixty-five surgeons in 24 centres recruited and LIHNCS was powered for 300 cases. Following successful recruitment, extension was granted for progression to 409, including 300 T1 and T2 cases. Patient acceptance was 89%. Median follow up is 36.5 months and 118 patients have died to date. Significantly fewer patients in the Lugols arm required further mucosal resection after primary surgery (p = 0.005). In as treated analysis dysplasia is reduced at resection margins for T1 and T2 tumours (p = 0.04). Conclusions: Lugol's iodine visualisation of dysplasia at curative surgical resection of oral and oropharynx SCC is associated with reduced requitement for further mucosal resection and appears to result in reduced dysplasia at mucosal resection margins. Clinical trial information: ISRCTN03712770.