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

Renaud Garrel (1, 2) , Gilles Poissonnet (3) , Antoine Moyà Plana (4, 5) , Nicolas Fakhry (6, 7) , Gilles Dolivet (8) , Benjamin Lallemant (9, 10) , Jérôme Sarini (11) , Sebastien Vergez (11) , Bruno Guelfucci (12) , Olivier Choussy (13) , Vianney Bastit (14) , Fanny Richard (1) , Valérie Costes (1, 15) , Paul Landais (16) , Françoise Perriard (16) , Jean Pierre Daures (16) , Delphine de Verbizier (1) , Valentin Favier (1) , Marie de Boutray (1)

1 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
2 UM - Université de Montpellier
3 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
4 IGR - Institut Gustave Roussy
5 U981 - Biomarqueurs prédictifs et nouvelles stratégies moléculaires en thérapeutique anticancéreuse
6 LPL - Laboratoire Parole et Langage
7 APHM - Assistance Publique - Hôpitaux de Marseille
8 UNICANCER/ICL - Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy]
9 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
10 IRCM - U1194 Inserm - UM - Institut de Recherche en Cancérologie de Montpellier
11 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
12 Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse
13 Institut Curie [Paris]
14 UNICANCER/CRLC - Centre Régional de Lutte contre le Cancer François Baclesse [Caen]
15 Pathogénèse et contrôle des infections chroniques (PCCI)
16 AIDMP - Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415

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.

Domaines: Sciences du Vivant [q-bio]

Renaud Garrel, Gilles Poissonnet, Antoine Moyà Plana, Nicolas Fakhry, Gilles Dolivet, 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. Journal of Clinical Oncology, 2020, 38 (34), pp.4010-4018. ⟨10.1200/JCO.20.01661⟩. ⟨hal-03222336⟩