Fear of cancer recurrence in patients undergoing active surveillance versus standard surgery for oesophageal cancer (SANO trial)

The SANO-trial showed active surveillance was non-inferior to standard surgery in survival at 2-year follow-up and improved short-term health-related quality of life (HRQOL) for patients with complete clinical response (CCR) after neoadjuvant chemoradiotherapy (nCRT) for oesophageal cancer1. Although repeated evaluations to detect regrowth during active surveillance may increase anxiety and negatively affect emotional well-being, analyses of standard HRQOL domains did not reveal differences in emotional functioning between the groups2. However, instruments specifically designed to assess cancer-related worry may be more sensitive to assess fear of cancer recurrence (FCR)3. In this study, we compared FCR in patients undergoing active surveillance versus standard surgery. Patients with CCR undergoing active surveillance or standard surgery 12 weeks after nCRT in the stepped-wedge cluster randomized SANO trial were included. FCR was measured using the six-item Cancer Worry Scale at baseline (before nCRT), 3 months (before esophagectomy in the surgery group), and 6, 9, 12, 16, 20, and 24 months after nCRT. Repeated measures analysis was used to compare groups, adjusted for age, sex, tumour histology, histological grade, clinical T/N-category, WHO performance status, and hospital of inclusion. Mean difference (MD) estimates quantified treatment effects across time points. Effect sizes were expressed using Cohen’s d (CD) to enable standardized comparisons, with CD > 0.5 considered clinically relevant. Possible scores range from 6 to 24 with higher scores indicating more worry. High FCR was defined as >9 points, based on validation studies and given for interpretation but not used in the analysis4. Patients who developed distant metastases were analysed up to, but not after, the time of diagnosis. Patients in the active surveillance group who developed locoregional regrowth and underwent surgery were also analysed after surgery. Sensitivity analyses were performed excluding questionnaires from the time point that patients under active surveillance developed locoregional regrowth, to assess FCR in patients with sustained CCR.