Objectives In endometrial cancer few randomized controlled trials were conducted to assess the role of different settings of follow-up in improving overall survival. The TOTEM study (NCT00916708) was planned to compare an intensive (INT) vs minimalist (MIN) 5-year follow-up regimen in endometrial cancer patients in terms of overall survival (OS).
Methods Patients surgically treated for endometrial cancer, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based follow-up regimens. The aim of the study was to demonstrate an improvement from 75% to 80% (expected hazard ratio, HR=0.78) of the 5-year OS with the INT regimen. Secondary objectives were to compare relapse free survival (RFS) and health-related quality of life (HRQL).
Results 1884 patients were randomized in 42 centers between 2008 and 2018, and 1847 patients were available for the final analysis. After a median follow-up of 66 months, the 5-year OS was 91.3%, 90.6% in the INT and 91.9% in the MIN arms, respectively (HR=1.12, 95%CI 0.85–1.48, p=0.429). Comparing the INT vs MIN arms, the 5-year OS were 94.1% and 96.8% (HR=1.48, 0.92–2.37, p=0.104) in the LoR and 85.3% and 84.7% (HR=0.96, 0.68–1.36, p=0.814) in the HiR group. The two arms did not show differences in terms of RFS and HRQL.
Conclusions Intensive follow-up in endometrial cancer treated patients did not improve OS, even in HiR patients, nor influenced health-related quality of life. Frequent routine use of imaging and laboratory exams in these patients should be discouraged.
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