Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial. - Université de Lille Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2022

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

Paolo Zola
Giovannino Ciccone
Elisa Piovano
L. Fuso
  • Fonction : Auteur
D. Di Cuonzo
  • Fonction : Auteur
A. Castiglione
  • Fonction : Auteur
Eva Pagano
E. Peirano
  • Fonction : Auteur
F. Landoni
  • Fonction : Auteur
Enrico Sartori
O. Bertetto
  • Fonction : Auteur
A. Ferrero
  • Fonction : Auteur

Résumé

PURPOSE In the absence of clear evidence from randomized trials, the intensity of follow-up regimens after surgical treatment of endometrial cancer is highly variable in clinical practice. To reduce this uncertainty, we conducted a randomized trial to test whether an intensive (INT) versus a minimalist (MIN) follow-up regimen improves 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 and France) including patients surgically treated for endometrial cancer, in complete clinical remission, International Federation 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 powered to 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 1,847 patients (98.7%) were available for the final analysis (60% low risk). After a median follow-up of 69 months, the 5-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 of relapse, and degree of adherence of the center to the scheduled follow-up. The probability of detecting a relapse was 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-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the MIN regimens used in this trial.
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Dates et versions

hal-04429225 , version 1 (14-02-2024)

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Citer

Paolo Zola, Giovannino Ciccone, Elisa Piovano, L. Fuso, D. Di Cuonzo, et al.. Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial.. Journal of Clinical Oncology, 2022, Journal of Clinical Oncology, 40 (33), pp.3817-3827. ⟨10.1200/JCO.22.00471⟩. ⟨hal-04429225⟩

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