A study just published in the Journal of Clinical Oncology compared two different ways of organizing the post-treatment surveillance program in carcinoma of the uterus body.
Since the carcinoma of the body of the uterusis characterized by high incidence and good survival, the surveillance or follow-up program translates into a complex of procedures with a strong economic and social impact, based on the hypothesis, never proved, that anticipating the recognition of a relapse results in improved survival.
In light of these considerations, in the context of the Oncological Network of Piedmont and Valle d'Aosta an experimental study, called TOTEM, was designed in 2008 to compare two modalities of organizational follow-up (one "intensive" and the other one "minimalist") in patients treated for this type of tumor, with different frequency and type of examinations to be performed over the 5 years after the intervention.
The initiative is resulting from the close collaboration between the Unit of Oncological Gynecology of the Universityof Turin, the Oncological Network of Piedmont and Valle d'Aosta, which provided the financial support, and the SSD Clinical Epidemiology - CPO Piemonte of the AOU Città della Salute e della Scienza in Turin, who contributed on a methodological and statistical level to the design, data collection (on the EPICLIN platform) and the final analysis.
The study involved 39 Italian institutions and 3 French institutions and concluded the enrollment of patients in July 2018 with a total of 1847 women who agreed to participate in this research duly approved by the Ethics Committees of the participating centers.
The final results were very stark and showed that there is no utility in carrying out systematic examinations in the absence of clinical symptoms: 5-year survival in women followed with an intensive follow-up was 90.6%, against 91.9% of those followed with a minimalist regime. For example, over the 5 years considered, women followed with a minimalist pattern reduced the number of CT scans to be performed from 2 to 0 if at low risk, and from 5 to 2 if at high risk.
The article reporting these final results is just been published in the official journal of the American Association of Medical Oncology, the Journal of Clinical Oncology.
This important study, the only randomized trial that compared different follow-up patterns on the survival of women operated on for endometrial cancer, is an encouraging example of the ability collaboration between public structures in conducting pragmatic, independent, low-cost studies with significant impacts on clinical practice, limiting the number of unnecessary examinations to be performed during follow-up, with a consequent reduction in stress and radiation exposure for patients and cost containment for the Italian Public Health System (SSN).
The TOTEM study is dedicated to the memory of Alessandro Liberati, for his encouragement and for his contribution to the conception of the study and for its extraordinary commitment to spreading the culture of Evidence Based Medicine in the world of research and the SSN.
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