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