Active surveillance versus standard surgery after neoadjuvant chemoradiotherapy for oesophageal cancer: long-term results of a cluster-randomised controlled trial (SANO)
Menée à partir des données d'un essai randomisé multicentrique incluant 309 patients atteints d'un cancer de l'oesophage de stade localement avancé et présentant une réponse clinique complète après une chimioradiothérapie néoadjuvante (durée médiane de suivi : 76 mois), cette étude évalue la non-infériorité, du point de vue de la survie globale et de la survie sans maladie à cinq ans, d'une surveillance active par rapport à une chirurgie standard
Background: The Surgery As Needed for Oesophageal cancer (SANO)-trial demonstrated that active surveillance is non-inferior to standard surgery in terms of two-year overall survival in patients with a complete clinical response after neoadjuvant chemoradiotherapy (nCRT). Active surveillance resulted in improved quality of life. Here, we report five-year outcomes.
Methods: From 2017 to 2021, a multicentre stepped-wedge cluster-randomised non-inferiority trial was conducted. Patients with locally advanced oesophageal cancer who achieved complete clinical response (defined as no tumour detected on endoscopic biopsies, -ultrasound, or PET-CT) underwent active surveillance or standard surgery. Cox regression was used to compare five-year overall and disease-free survival, and the cumulative incidence of distant metastases was estimated using competing risk analysis.
Results: A total of 309 patients were included, 198 underwent active surveillance and 111 underwent standard surgery. Median follow-up was 76 months (IQR 67–86). Five-year overall survival was not statistically significantly different between active surveillance and standard surgery (50%, 95%CI 43-57 vs. 54%, 95%CI 46-64; HR 1.17, 95%CI 0.77-1.77) with similar results across histologic subtypes. Disease-free survival was not statistically significantly different (HR 1.39, 95% CI 0.94-2.06). The cumulative incidence of distant metastases at five years was significantly higher in the active surveillance group compared to the standard surgery group (46%, 95%CI 39-53 vs. 29%, 95%CI 21-37; P<.01). Overall, 85 of 198 patients (43%) avoided oesophagectomy, including those with sustained complete clinical response at last follow-up or distant metastases detected within six months after nCRT.
Conclusions: Overall survival at five years is not statistically significantly different between active surveillance and standard surgery in patients with oesophageal cancer and a complete clinical response after nCRT, despite a higher incidence of distant metastases in the active surveillance group. These findings support active surveillance as a feasible treatment strategy in selected patients.
Annals of Oncology , article en libre accès, 2026