Documents
-
- Full text
- Publisher's Version
- under embargo until 2026-07-02
- Full text at publishers site
In Collections
This item can be found in the following collections:
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...
Show moreBackground: 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.
Show less- All authors
- Panday, S.S.G.G.; Wilk, B.J. van der; Eyck, B.; Lagarde, S.M.; Rosman, C.; Noordman, B.J.; Valkema, M.J.; Bisseling, T.M.; Coene, P.P.L.O.; Det, M.J. van; Dekker, J.W.T.; Dieren, J.M. van; Doukas, M.; Esser, S. van; Fiets, W.E.; Hartgrink, H.H.; Heisterkamp, J.; Holster, I.L.; Husson, O.; Klarenbeek, B.; Kouw, E.; Kouwenhoven, E.A.; Luyer, M.D.; Mostert, B.; Nieuwenhuijzen, G.A.P.; Oostenbrug, L.E.; Pierie, J.P.; Sandick, J.W. van; Sosef, M.N.; Spaander, M.C.W.; Steyerberg, E.W.; Valkema, R.; Zaag, E.S. van der; Lingsma, H.F.; Klaveren, D. van; Lanschot, J.J.B. van; Wijnhoven, B.P.L.; SANO Study Grp
- Date
- 2026-01-01
- Journal
- BJS
- Volume
- 113
- Issue
- 1