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O004/#393 Does intensive follow-up improve overall survivalin endometrial cancer patients? Results from the totem randomized controlled trial
  1. P Zola1,
  2. G Ciccone2,
  3. R Angioli3,
  4. C Terranova3,
  5. E Piovano4,
  6. L Fuso5,
  7. D Di Cuonzo6,
  8. E Peirano1,
  9. AM Perrone7,
  10. VD Mandato8,
  11. L Zavallone9,
  12. F Chiudinelli10,
  13. R Berretta11,
  14. S Loda12,
  15. S Greggi13,
  16. M Adorni14,
  17. E Busato15,
  18. G Comerci16,
  19. M Fambrini17 and
  20. A Ferrero5
  1. 1University of Turin, Surgical Sciences, Turin, Italy
  2. 2Città della Salute e della Scienza, University of Turin, Cancer and Epidemiology Unit, Cerms and Cpo Piemonte, Turin, Italy
  3. 3Campus Biomedico, Gynecologic Oncology, Rome, Italy
  4. 4Ospedale Regina Montis Regalis, Obstetrics and Gynaecology Unit, Mondovì, Italy
  5. 5ASO Ordine Mauriziano, Obstetrics and Gynaecology Unit, Turin, Italy
  6. 6Città della Salute e della Scienza, University of Turin, Cancer and Epidemiology Unit, Cpo Piemonte, Turin, Italy
  7. 7University of Bologna, Gynecologic Oncology, Bologna, Italy
  8. 8Azienda Unità Sanitaria Locale – IRCCS, Reggio Emilia, Unit of Obstetrics and Gynecology, Reggio Emilia, Italy
  9. 9Ospedale degli Infermi, Department of Medical Oncology, Biella, Italy
  10. 10PO Manerbio, ASST Garda, Obstetrics and Gynaecology Unit, Manerbio, Italy
  11. 11University of Parma, Department of Medicine and Surgery, Parma, Italy
  12. 12AO Spedali Civili, Obstetrics and Gynaecology Unit, Brescia, Italy
  13. 13Istituto Nazionale Tumori, IRCSS, ‘Fondazione G. Pascale’, Department of Gynecologic Oncology, Naples, Italy
  14. 14ASO San Gerardo de’ Tintori, Obstetrics and Gynaecology Unit, Monza, Italy
  15. 15Treviso Hospital, Obstetrics and Gynaecology Unit, Treviso, Italy
  16. 16Santa Maria dele Croci Hospital, Obstetrics and Gynaecology Unit, Ravenna, Italy
  17. 17University of Florence, Department of Biomedical, Experimental and Clinical Sciences, Division of Obstetrics and Gynecology, Florence, Italy


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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