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Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial.

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Zola, Paolo | Ciccone, Giovannino | Piovano, Elisa | Fuso, L. | Di Cuonzo, D. | Castiglione, A. | Pagano, Eva | Peirano, E. | Landoni, F. | Sartori, Enrico | Narducci, Fabrice | Bertetto, O. | Ferrero, A.

Edité par CCSD ; American Society of Clinical Oncology -

International audience. PURPOSE In the absence of clear evidence from randomized trials, the intensity of follow-up regimens aftersurgical treatment of endometrial cancer is highly variable in clinical practice. To reduce this uncertainty, weconducted a randomized trial to test whether an intensive (INT) versus a minimalist (MIN) follow-up regimenimproves overall survival (OS) in patients undergoing operation for endometrial cancer.METHODS The TOTEM study was a large, pragmatic randomized trial, conducted in 42 hospitals (in Italy andFrance) including patients surgically treated for endometrial cancer, in complete clinical remission, InternationalFederation of Gynecology and Obstetrics stage I-IV. After stratification by center and risk of relapse (low or high),patients were randomly assigned (1:1) to INT or MIN hospital-based follow-up regimens. The study was poweredto demonstrate an absolute improvement of 5% of the 5-year OS with the INT regimen.RESULTS In total, 1,871 patients were randomly assigned between November 2008 and July 2018, and 1,847patients (98.7%) were available for the final analysis (60% low risk). After a median follow-up of 69 months, the5-year OS was 90.6% in the INT and 91.9% in the MIN arms (hazard ratio, 1.13, 95% CI, 0.86 to 1.50,P 5 .380). No differences in OS were found in subgroup analyses considering age, cancer treatment, risk ofrelapse, and degree of adherence of the center to the scheduled follow-up. The probability of detecting a relapsewas slightly higher in the INT arm (hazard ratio, 1.17; 95% CI, 0.92 to 1.48; P 5 .194).CONCLUSION An INT follow-up in endometrial cancer–treated patients does not improve OS, even in high-riskpatients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, orimaging investigations to the MIN regimens used in this trial.

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