1. Comment on 'Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort'
- Author
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Fran Ridout, Chi-Hwa Chan, Sharon Cheung, Graham Putnam, Iain Hutchison, Bob Woodwards, Richard Shaw, I. Martin, Leo Cheng, Keith A. Webster, Graham Smith, Colin Edge, Nick Grew, Manu Patel, Tim Mellor, Nicholas Kalavrezos, Christian Surwald, Martin Danford, Simon Whitley, Andrew J. Baldwin, William P. Smith, Peter Hardee, P. Praveen, Andrew Burns, Janavikulam Thiruchelvam, Peter A. Brennan, Iain McVicar, Malcolm W. Bailey, Chris Avery, Andrew C. Camilleri, Keith Jones, Neil P. Shah, Allan Hackshaw, Stuart Hislop, Wayne Halfpenny, and Joseph McManners
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Lower risk ,Disease-Free Survival ,Article ,law.invention ,Cohort Studies ,03 medical and health sciences ,Text mining ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Correspondence ,Medicine ,Humans ,Stage (cooking) ,030223 otorhinolaryngology ,Aged ,Neoplasm Staging ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,business.industry ,General surgery ,Oral cancer ,Hazard ratio ,Cancer ,Neck dissection ,Middle Aged ,medicine.disease ,Treatment Outcome ,Oncology ,Elective Surgical Procedures ,Surgical oncology ,Meta-analysis ,030220 oncology & carcinogenesis ,Cohort ,Carcinoma, Squamous Cell ,Neck Dissection ,Female ,Mouth Neoplasms ,business ,Neck ,Cohort study - 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 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.
- Published
- 2020