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

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 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 (8). ISSN 1532-1827. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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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.

Item Type:	Article
Additional Information:	This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects:	QZ Pathology. Oncology WU Dentistry. Oral surgery
Divisions:	Planned IP Care > Oncology and Clinical Haematology
Related URLs:	https://www.ncbi.nlm.nih.gov/pubmed/?ter...
Depositing User:	Jamie Edgar
Date Deposited:	21 Oct 2019 08:11
Last Modified:	23 Oct 2019 11:47
URI:	http://www.repository.uhblibrary.co.uk/id/eprint/2501

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