Renaud Garrel1, Gilles Poissonnet2, Antoine Moyà Plana3, Nicolas Fakhry4, Gilles Dolivet5, Benjamin Lallemant6, Jérôme Sarini7, Sebastien Vergez7, Bruno Guelfucci8, Olivier Choussy9, Vianney Bastit10, Fanny Richard1, Valérie Costes11, Paul Landais12, Françoise Perriard12, Jean Pierre Daures12, Delphine de Verbizier13, Valentin Favier1, Marie de Boutray1. 1. Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France. 2. Head Neck Surgery Department, Antoine Lacassagne Center, Nice, France. 3. Head Neck Surgery Department, Institut Gustave Roussy, Villejuif, France. 4. Head Neck Surgery Department, Marseille University Hospital Center, Marseille, France. 5. Head Neck Surgery Department, Alexis Vautrin Center, Vandœuvre-lès-Nancy, France. 6. Head Neck Surgery Department, Nîmes University Hospital Center, Nîmes, France. 7. Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France. 8. Head Neck Surgery Department, Toulon Hospital Center, Toulon, France. 9. Head Neck Surgery Department, Curie Institute, Paris, France. 10. Head Neck Surgery Department, François Baclesse Center, Caen, France. 11. Pathology Department, Montpellier University Hospital Center, Montpellier, France. 12. Clinical Research University Institute, UPRES EA 2415, Montpellier, France. 13. Nuclear Medicine Department, Montpellier University Hospital Center, Montpellier, France.
Abstract
PURPOSE:Sentinel node (SN) biopsy is accurate in operable oral and oropharyngeal cT1-T2N0 cancer (OC), but, to our knowledge, the oncologic equivalence of SN biopsy and neck lymph node dissection (ND; standard treatment) has never been evaluated. METHODS: In this phase III multicenter trial, 307 patients with OC were randomly assigned to (1) the ND arm or (2) the SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery). The primary outcome was neck node recurrence-free survival (RFS) at 2 years. Secondary outcomes were 5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS). Other outcomes were hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions during the 2 years after surgery. RESULTS: Data on 279 patients (139 ND and 140 SN) could be analyzed. Neck node RFS was 89.6% (95% CI, 0.83% to 0.94%) at 2 years in the ND arm and 90.7% (95% CI, 0.84% to 0.95%) in the SN arm, confirming the equivalence with P < .01. The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms. The median hospital stay length was 8 days in the ND arm and 7 days in the SN arm (P < .01). The functional outcomes were significantly worse in the ND arm until 6 months after surgery. CONCLUSION: This study demonstrated the oncologic equivalence of the SN and ND approaches, with lower morbidity in the SN arm during the first 6 months after surgery, thus establishing SN as the standard of care in OC.
RCT Entities:
PURPOSE: Sentinel node (SN) biopsy is accurate in operable oral and oropharyngeal cT1-T2N0 cancer (OC), but, to our knowledge, the oncologic equivalence of SN biopsy and neck lymph node dissection (ND; standard treatment) has never been evaluated. METHODS: In this phase III multicenter trial, 307 patients with OC were randomly assigned to (1) the ND arm or (2) the SN arm (experimental arm: biopsy alone if negative, or followed by ND if positive, during primary tumor surgery). The primary outcome was neck node recurrence-free survival (RFS) at 2 years. Secondary outcomes were 5-year neck node RFS, 2- and 5-year disease-specific survival (DSS), and overall survival (OS). Other outcomes were hospital stay length, neck and shoulder morbidity, and number of physiotherapy prescriptions during the 2 years after surgery. RESULTS: Data on 279 patients (139 ND and 140 SN) could be analyzed. Neck node RFS was 89.6% (95% CI, 0.83% to 0.94%) at 2 years in the ND arm and 90.7% (95% CI, 0.84% to 0.95%) in the SN arm, confirming the equivalence with P < .01. The 5-year RFS and the 2- and 5-year DSS and OS were not significantly different between arms. The median hospital stay length was 8 days in the ND arm and 7 days in the SN arm (P < .01). The functional outcomes were significantly worse in the ND arm until 6 months after surgery. CONCLUSION: This study demonstrated the oncologic equivalence of the SN and ND approaches, with lower morbidity in the SN arm during the first 6 months after surgery, thus establishing SN as the standard of care in OC.
Authors: Rutger Mahieu; Dominique N V Donders; Gerard C Krijger; F F Tessa Ververs; Remmert de Roos; John L M M Bemelmans; Rob van Rooij; Remco de Bree; Bart de Keizer Journal: Eur J Nucl Med Mol Imaging Date: 2021-12-28 Impact factor: 10.057
Authors: Olof Nilsson; Johan Knutsson; Fredrik J Landström; Anders Magnuson; Mathias von Beckerath Journal: Laryngoscope Investig Otolaryngol Date: 2022-08-24
Authors: Remco de Bree; Bart de Keizer; Francisco J Civantos; Robert P Takes; Juan P Rodrigo; Juan C Hernandez-Prera; Gyorgy B Halmos; Alessandra Rinaldo; Alfio Ferlito Journal: Eur Arch Otorhinolaryngol Date: 2020-12-28 Impact factor: 2.503
Authors: Rutger Mahieu; Dominique N V Donders; Jan Willem Dankbaar; Remco de Bree; Bart de Keizer Journal: J Clin Med Date: 2022-08-31 Impact factor: 4.964