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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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.
SUBMITTER: Hutchison IL
PROVIDER: S-EPMC6888839 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The purpose of this study was to evaluate and compare the treatment outcomes of partial glossectomy with or without elective neck dissection in patients with tongue squamous cell carcinoma (SCCa).A total of 98 patients who were diagnosed with tongue SCCa and underwent partial glossectomy between 2005 and 2014 were evaluated. Only 14 patients received elective neck dissection, and 84 patients received only partial glossectomy.There were 56 men and 42 women with a mean age of 57 years and mean follow-up period of 33.7 months. There were 70 patients graded as T1 and 28 as T2. The total occult metastasis rate was 17.3%. The 5-year overall survival rate was 83.3% with elective neck dissection and 92.4% with observation. The 5-year disease-free survival rate was in 70.7% in the elective neck dissection group and 65.3% in the observation group.We retrospectively reviewed the records of 98 patients with tongue SCCa. These patients were divided into two groups, those who underwent elective neck dissection and those who did not. There was no statistically significant difference between the groups undergoing partial glossectomy with or without elective neck dissection.
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