Author:
Hutchison Iain L.,Ridout Fran,Cheung Sharon M. Y.,Shah Neil,Hardee Peter,Surwald Christian,Thiruchelvam Janavikulam,Cheng Leo,Mellor Tim K.,Brennan Peter A.,Baldwin Andrew J.,Shaw Richard J.,Halfpenny Wayne,Danford Martin,Whitley Simon,Smith Graham,Bailey Malcolm W.,Woodwards Bob,Patel Manu,McManners Joseph,Chan Chi-Hwa,Burns Andrew,Praveen Prav,Camilleri Andrew C.,Avery Chris,Putnam Graham,Jones Keith,Webster Keith,Smith William P.,Edge Colin,McVicar Iain,Grew Nick,Hislop Stuart,Kalavrezos Nicholas,Martin Ian C.,Hackshaw Allan
Abstract
Abstract
Background
Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours.
Methods
We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials.
Results
Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 (p = 0.18), and DFS HR = 0.66 (p = 0.04). Corresponding per-protocol results were: OS HR = 0.59 (p = 0.054), and DFS HR = 0.56 (p = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
Conclusion
SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours.
Clinical Trial Registration
NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.
Funder
Cancer Research UK
Saving Faces – The Facial Surgery Research Foundation (SF) and Elliott Bernerd
Publisher
Springer Science and Business Media LLC
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