Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort
Open Access
- 15 October 2019
- journal article
- research article
- Published by Springer Science and Business Media LLC in British Journal of Cancer
- Vol. 121 (10), 827-836
- https://doi.org/10.1038/s41416-019-0587-2
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.Keywords
Funding Information
- Cancer Research UK (C17797/A7260)
- Saving Faces – The Facial Surgery Research Foundation (SF) and Elliott Bernerd
This publication has 32 references indexed in Scilit:
- Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigatorsBMJ Open, 2013
- Can head and neck cancer patients be discharged after three years?The Journal of Laryngology & Otology, 2013
- Prospective randomized study of selective neck dissection versus observation for N0 neck of early tongue carcinomaHead & Neck, 2009
- Elective neck dissection for the management of the N0 neck in early cancer of the oral tongue: Need for a randomized controlled trialHead & Neck, 2009
- Wait‐and‐see policy for the N0 neck in early‐stage oral and oropharyngeal squamous cell carcinoma using ultrasonography‐guided cytology: Is there a role for identification of the sentinel node?Head & Neck, 2002
- Supraomohyoid neck dissection in the treatment of T1/T2 squamous cell carcinoma of oral cavityThe American Journal of Surgery, 1994
- Improved survival in the treatment of squamous carcinoma of the oral tongueThe American Journal of Surgery, 1993
- The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in OncologyJNCI Journal of the National Cancer Institute, 1993
- Patterns of cervical lymph node metastasis from squamous carcinomas of the upper aerodigestive tractThe American Journal of Surgery, 1990
- Elective versus therapeutic neck dissection in early carcinoma of the oral tongueThe American Journal of Surgery, 1989