Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer: trial

Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer

Population

Operable T1-T2 N0 oral cavity and oropharyngeal squamous cell cancer (the abstract uses 'OC' for oral and oropharyngeal cancer)

Design

Phase III multicentre equivalence trial: 307 patients with operable T1-T2 N0 oral or oropharyngeal cancer were randomised to neck node dissection (ND arm, standard treatment) or a sentinel node strategy (SN arm: biopsy alone if negative, followed by neck dissection if positive, during primary tumour surgery). Data on 279 patients (139 ND, 140 SN) were analysable. Primary outcome: neck node recurrence-free survival at 2 years; secondary outcomes included 5-year neck node RFS, 2- and 5-year disease-specific survival and overall survival, hospital stay and neck and shoulder morbidity.

Primary endpoint

Neck node recurrence-free survival

Arms

Neck node dissection (control, n = 139): Neck node dissection (standard treatment)
Sentinel node biopsy strategy (experimental, n = 140): Sentinel node biopsy alone if negative, or followed by neck dissection if positive, during primary tumour surgery

People

Garrel R, Montpellier University Hospital (sponsor on ClinicalTrials.gov)

Δ 24-month Neck node recurrence-free survival+1.1 points

Show the numbers

Results reported for Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer
Endpoint	Analysis	Sentinel node biopsy strategy	Neck node dissection	Effect
Neck node recurrence-free survivalAnalysable patients (139 neck dissection, 140 sentinel node) of 307 randomised	primaryGarrel 2020	90.7% at 2 y	89.6% at 2 y	P<.01Equivalence test. The abstract prints the 95% confidence intervals as 0.83% to 0.94% and 0.84% to 0.95%, apparently proportions rather than percentages; they are not entered as intervals. The 5-year neck node RFS and 2- and 5-year disease-specific and overall survival were not significantly different between arms (no values in the abstract).

Results reported for Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer
Endpoint	Analysis	Sentinel node biopsy strategy	Neck node dissection	Effect
Neck node recurrence-free survivalAnalysable patients (139 neck dissection, 140 sentinel node) of 307 randomised	primaryGarrel 2020	90.7% at 2 y	89.6% at 2 y	P<.01Equivalence test. The abstract prints the 95% confidence intervals as 0.83% to 0.94% and 0.84% to 0.95%, apparently proportions rather than percentages; they are not entered as intervals. The 5-year neck node RFS and 2- and 5-year disease-specific and overall survival were not significantly different between arms (no values in the abstract).

Appears in

2020 Sentinel-node strategy vs neck dissection in early oral cancer

Sources

Garrel R, Poissonnet G, Moyà Plana A, Fakhry N, Dolivet G, Lallemant B, et al. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020;38(34):4010-4018.
PubMed DOI