Article Text
Abstract
Introduction/Background*Intensive follow-up (FU) in cancer patients can be a source of stress for patients and absorbs a lot of health system resources. The TOTEM study was planned to compare an intensive (INT) vs minimalist (MIN) 5-year FU regimen in endometrial cancer patients in terms of overall survival (OS), health-related-quality-of-life (HRQL) and costs. This report focuses on HRQL and costs.
Methodology Patients surgically treated for endometrial cancer, FIGO stage I-IV, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based FU regimens. HRQL was assessed at baseline-6–12 months and then yearly (with the SF-12 Physical and Mental Health Summary Scale). For per-participant average estimates, costs were tallied for each participant and divided by FU regimen to evaluate the difference between the two regimens. Bootstrapping was used for Confidence Intervals (CI) of cost differences between the FU regimens.
Result(s)*1871 patients were randomized in 42 centers, and 1847 patients were available for the final analysis (60% LoR). No difference in terms of OS was observed. Compliance with the FU scheduled visits was 75.3%, similar between INT (74.7%) and MIN (75.9%) arms. In LoR the MIN arm performed slightly more procedures than expected (5080 vs 4955) and the INT arm performed fewer tests than expected (7505 vs 8830). In the HiR the MIN arm performed approximately the number of procedures expected (3621 vs 4004), while the INT arm performed far fewer exams than expected (7655 vs 11681). HRQL did not differ between arms (figures 1 and 2). In LoR patients, the mean real cost of INT arm was 698 euro vs 273 euro for the MIN arm. In HiR patients, the mean real cost of INT arm was 1116 euro vs 632 euro for the MIN arm. The estimated cost difference between the two FU regimens was 447.20 euro (95% CI 398.87–494.97 euro).
Conclusion*In endometrial cancer treated patients the regimen of FU has no impact on HRQL. For both LoR and HiR patients there is a cost-saving with the MIN approach of about 450 euro per patient.