Health-related quality of life of patients undergoing active surveillance versus standard surgery for oesophageal cancer (SANO trial).

BACKGROUND

The SANO trial demonstrated that active surveillance after neoadjuvant chemoradiotherapy (nCRT) has non-inferior 2-year overall survival compared with standard surgery in patients with locally advanced oesophageal cancer. This aim of this study was to compare health-related quality of life (HRQoL) in both groups.

METHODS

Patients with a cCR after nCRT were included and randomized within the stepped-wedge cluster-randomized SANO trial to active surveillance or surgery. HRQoL was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and the EORTC Quality of Life Questionnaire-Oesophago-Gastric Module (QLQ-OG25) before nCRT (baseline) and at 3 (before surgery), 6, 9, 12, 16, 20, and 24 months after nCRT. Predefined endpoints included dysphagia (QLQ-OG25), as well as dyspnoea, fatigue, physical functioning, and emotional functioning (all QLQ-C30). Repeated measures analysis was used to assess between-group differences. Cohen's d (CD) >0.5 was considered clinically relevant.

RESULTS

A total of 274 patients were included, with a response rate of 85.4% (234 patients responded in total; 169 active surveillance patients and 65 standard surgery patients). At 6 months after nCRT, scores for dysphagia, dyspnoea, fatigue, and physical functioning were significantly better in the active surveillance group (CD of -1.09, -0.63, -0.70, and 0.77 respectively; all P ≤ 0.001). Dysphagia remained significantly better in the active surveillance group at 9, 12, and 24 months after nCRT (CD of -0.60 (P = 0.001), -0.46 (P = 0.015), and -0.79 (P < 0.001) respectively). No differences were found for other domains.

CONCLUSION

Active surveillance patients experienced less dysphagia, dyspnoea, and fatigue, as well as better physical functioning, at 6 months after nCRT compared with standard surgery patients. Dysphagia remained improved at 2 years. These results support an active surveillance approach in patients with oesophageal cancer who attain a cCR after nCRT.

REGISTRATION NUMBER: NTR-6803 (Netherlands Trial Register).