Does addition of neck ultrasonography to physical examination, in follow-up of patients with early stage, clinically node negative oral cancers, influence outcome? A randomized control trial (RCT).

Abstract

6020 Background: We previously reported results of a RCT demonstrating superiority of elective neck dissection (END) over therapeutic neck dissection (TND) in early oral cancer patients with clinically node negative neck1. We now report the results of the second question in this trial –elucidating the role of ultrasonography (USG) during follow-up, based on the hypothesis that addition of imaging would detect neck nodes earlier and improve salvage and survival (NCT00193765). Methods: Patients with lateralized T1 or T2 squamous carcinoma of oral cavity after initial surgery (excision of primary with/without neck dissection) were randomized to follow up with physical examination plus neck ultrasound (PE+USG) performed in a standardized manner versus physical examination (PE). The primary end point was overall survival (OS)1. Results: This report includes results of 500 patients in the same cohort reported earlier1with a median follow up of 39 months; 252 patients were randomized to PE+USG and 244 to PE. Both arms were balanced for stratification factors and surgical procedure (END vs. TND). There were 118 recurrences with 67 deaths in PE+USG and 109 recurrences with 62 deaths in PE, respectively. There was no OS difference between PE+USG and PE in unadjusted analysis (3-year OS 73.3% and 73.8%, respectively, HR = 1.02, 95%CI 0.73-1.45, p = 0.89) and after adjustment (HR = 0.81, 95%CI 0.51-1.29, p = 0.37) for stratification factors, prognostic factors, surgical treatment (END vs. TND) and an interaction term between two study questions, in a Cox model. END vs. TND continued to be highly significant for OS in this model (HR = 0.54, 95%CI 0.32 - 0.92, p = 0.02). Within TND (wait and watch) arm there was no significant difference between PE+USG and PE (3-year OS 67.3% and 67.6% respectively, HR = 0.96, 95%CI 0.62–1.5, p = 0.86). Conclusions: Neck ultrasound confers no survival advantage over physical examination in postoperative follow-up of clinically node negative early stage oral cancer patients. 1. N Engl J Med 2015;373:521-9 Clinical trial information: NCT00193765.