Titre :

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

Auteur(s) :

Zola, P. [Auteur]
Ciccone, G. [Auteur]
Piovano, E. [Auteur]
Fuso, L. [Auteur]
Di Cuonzo, D. [Auteur]
Castiglione, A. [Auteur]
Pagano, E. [Auteur]
Peirano, E. [Auteur]
Landoni, F. [Auteur]
Sartori, E. [Auteur]
Narducci, Fabrice [Auteur]
Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192
Bertetto, O. [Auteur]
Ferrero, A. [Auteur]

Titre de la revue :

Journal of Clinical Oncology

Nom court de la revue :

J Clin Oncol

Pagination :

JCO2200471

Date de publication :

2022-07-23

ISSN :

1527-7755

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

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, ...
Lire la suite >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.Lire moins >

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192

Date de dépôt :

2023-12-13T04:11:05Z
2024-01-31T13:44:48Z