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577 Impact of different follow-up regimens on health-related quality of life and costs in endometrial cancer patients: results from the TOTEM randomized trial
  1. Rosalba Rosato1,2,
  2. Annamaria Ferrero3,4,
  3. Paola Mosconi5,
  4. Giovannino Ciccone2,
  5. Daniela Di Cuonzo2,
  6. Andrea Evangelista2,
  7. Luca Fuso3,
  8. Elisa Piovano6,
  9. Eva Pagano2,
  10. Maria Elena Laudani4,
  11. Luca Pace4,
  12. Paolo Zola4 and
  13. TOTEM Collaborative Group7
  1. 1Dipartimento di Psicologia, Università degli studi di Torino, Torino, Italy
  2. 2Epidemiologia Clinica e Valutativa, AOU Città della Salute e della Scienza di Torino e CPO Piemonte, Torino, Italy
  3. 3SCDU Ginecologia e Ostetricia, AO Ordine Mauriziano, Torino, Italy
  4. 4Dipartimento di Scienze Chirurgiche, Università degli studi di Torino, Torino, Italy
  5. 5Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy
  6. 6SCDU Ginecologia e Ostetricia 2U, Ospedale Sant’Anna, AOU Città della Salute e della Scienza di Torino, Torino, Italy
  7. 7TOTEM Collaborative Group, Italy, Italy


Introduction/Background The TOTEM randomized clinical trial showed no difference in 5-years survival between patients with minimal (MIN) and intensive (INT) follow-up after surgery for endometrial cancer. The present study has the aim to assess possible differences between the two arms in health-related quality of life (HRQoL) and healthcare costs (secondary study outcomes).

Methodology HRQoL was assessed by the SF-12 and the Psychological General Well-Being Scale (PGWB) questionnaires, at baseline, at 6 and 12 months and then yearly until 5 years of follow-up. Costs were analyzed at 4 years of follow up with the perspective of the national healthcare service, stratified by the risk level. Probability of having missing data was analyzed for both the endpoints.

Results 1847 patients were included in the analyses of secondary endpoints. Probability of missing data was not affected by the study arms (MIN vs INT OR: 0.97 95%CI: 0,87–1,08). Longitudinal changes in HRQoL scores did not differ between the two follow-up schemes (MIN vs INT SF-12 PCS: -0.573, CI95%: -1.31; 0.16; SF -12 MCS: -0.243, CI95%: -1.08; 0.59; PWB: -0.057, CI95%: -0,88; 0,77). Mean cost difference between intensive and minimalist arms was 531€ for low risk and 683€ for high risk patients.

Conclusion In the follow-up of endometrial cancer after surgery, a minimalist regimen did not affect quality of life and was cost saving in both low and high risk recurrence patients. As previous results showed no survival benefit, a minimalist approach should be preferred in clinical practice. Quality of life and cost are relevant domains to complete a technology assessment but the high presence of missing data on secondary endpoints may be a critical issue that deserves special attention.

Disclosures The authors have no disclosures to declare. Funding: This work was supported by the Cancer Care Network of Piemonte and Valle d'Aosta.

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