Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort

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Hutchison, Iain L, Ridout, Fran, Cheung, Sharon MY, Shah, Neil, Hardee, Peter, Surwald, Christian, Thiruchelvam, Janavikulam, Cheng, Leo, Mellor, Tim K, Brennan, Peter A et al (show 26 more authors) , Baldwin, Andrew J, Shaw, Richard J ORCID: 0000-0002-5157-4042, 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 and Hackshaw, Allan (2019) Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort. BRITISH JOURNAL OF CANCER, 121 (10). pp. 827-836.

Text SEND Paper 24 July 2019.docx - Author Accepted Manuscript Download (82kB)

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.

Item Type:	Article
Uncontrolled Keywords:	Oral cancer
Depositing User:	Symplectic Admin
Date Deposited:	02 Dec 2019 08:35
Last Modified:	19 Jan 2023 00:18
DOI:	10.1038/s41416-019-0587-2
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3064030