Five-year results of a cluster-randomized trial of active surveillance versus standard surgery after neoadjuvant CRT for esophageal cancer

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), while active surveillance resulted in improved quality of life. Five-year results of the trial have now been reported. In this multicenter, stepped-wedge cluster-randomized trial, patients with locally advanced esophageal cancer who achieved complete clinical response after nCRT underwent active surveillance (n=198) or standard surgery (n=111). Median follow-up was 76 months (IQR 67-86). Five-year overall survival rate was 50% with active surveillance and 54% with surgery (HR 1.17; 95% CI 0.77-1.77) with similar results across histologic subtypes. Disease-free survival also was not statistically signficantly 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 (46%; 95% CI 39-53) than in the standard surgery group (29%; 95% CI 21037; p<0.01). Overall, 85 of 198 patients (43%) avoided esophagectomy. The authors conclude that overall survival at five years was not significantly different between active surveillance and standard surgery in patients with esophageal 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.