Sanjiv S G Gangaram Panday, Berend J. van der Wilk, Ben M Eyck, Sjoerd M Lagarde, Camiel Rosman, Bo J Noordman, Maria J Valkema, Tanya M Bisseling, Peter-Paul L O Coene, Marc J. van Det, Jan W T Dekker, Jolanda M. van Dieren, Michail Doukas, Stijn van Esser, W Edward Fiets, Henk H. Hartgrink, Joos Heisterkamp, I Lisanne Holster, Olga Husson, Bastiaan Klarenbeek, Eva Kouw, Ewout A Kouwenhoven, Misha D Luyer, Bianca Mostert, Grard A P Nieuwenhuijzen, Liekele E Oostenbrug, Jean-Pierre Pierie, Johanna W van Sandick, Meindert N Sosef, Manon C W Spaander, Ewout W Steyerberg, Roelf Valkema, Edwin S van der Zaag, Hester F Lingsma, David van Klaveren, J Jan B van Lanschot, Bas P L Wijnhoven, Other Members of the SANO Study Group, Arjun D. Koch, Suzan Nikkessen, Ate van der Gaast, Katharina Biermann, Lindsey Oudijk, Roy S. Dwarkasing, Joost J Nuyttens, Pieter C van der Sluis, Geert Bulte, Peter D Siersema, Harm Westdorp, Erik H.J.G. Aarntzen, Chella van der Post, Maartje C. van Rijk, Pètra M. Braam, H. Rütten, Marcel Verheij, S.J.L.B. Zweers, Lieke Hol, Ewout F W Courrech Staal, Hamoen Ke, Trudy Rapmund, Erwin van der Harst, A. Van der Linden, Hüseyin Aktaş, Polat Dura, Ronald B. Hoekstra, Ali Agool, Joop van Baarlen, Ellen M. Hendriksen, Henk Jan Mantel, R. Quispel, Sana A Mulder, Arjan J Verschoor, Marc R J ten Broek, R J Dallinga, Karen J. Neelis, Erlinde de Graaf, Thomas R. de Wijkerslooth, Marieke A. Vollebergh, Emilia C. Owers, Annemarieke Bartels-Rutten, Liudmila L. Kodach, Francine E M Voncken, Yvonne Hilhorst, Marjolein Warmerdam, Sietske Corporaal, Marco Polee, A Van Burg, Judith Nieken, Rinze Wolf, Vera Oppedijk, Marloes Emous, Daniel A Hess, Willemien Erkelens, S Cathrien, S Tromp-van Driel, Marc D. Zuijdwijk, H Doornewaard, Karin Müller, Peter van Duijvendijk, E. C. E. Wassenaar
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).