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1269 Real-world impact of surgical clinical trials in gynecological oncology: an interrupted time series analysis in France
  1. Floriane Jochum1,
  2. Madeleine Doll2,
  3. Enora Laas1,
  4. Lise Lecointre2,
  5. Fabien Reyal1,
  6. Cherif Akladios2 and
  7. Fabrice Lecuru1
  1. 1Institut Curie, Paris, France
  2. 2Strasbourg University Hospital, Strasbourg, France


Introduction/Background Clinical trials are comparable to population-level health interventions. However, their actual impact in real-life settings frequently remains unexplored. We developed a reproductible interrupted time series analysis to examine how pivotal surgical clinical trials have influenced and transformed medical practices in the treatment of cancer, using the LACC and LION trials as an example.

Methodology Utilizing data from the French national health insurance system database, which covers 98.8% of the population, our study analyzed two cohorts: (i) cervical cancer patients undergoing radical hysterectomies from 2013 to 2022, and (ii) advanced-stage ovarian cancer patients undergoing cytoreductive surgery from 2014 to 2022. A Bayesian interrupted time series analysis was employed to evaluate the impact of the LACC and LION trials on clinical practices across centers, by academic status and oncological expertise. The study analyzed both the impact of the initial oral presentation at a congress and the subsequent publication of the trials. The primary outcomes examined were the use of minimally invasive surgery (MIS) for the LACC trial and the performance of lymphadenectomy during cytoreductive surgery for the LION trial.

Results Our analysis included 7,108 cervical and 23,090 ovarian cancer patients. Academic centers showed a notable immediate decrease in MIS use following the LACC trial’s first oral presentation (Estimate: -0.11[-0.58;0.34]), whereas nonacademic centers presented a delayed and milder reduction post-publication (-0.18[-0.55;0.18] for nonacademic vs. -0.34[-0.78;0.09] for academic). High oncological expertise centers significantly reduced MIS usage after the trial’s publication (-0.35[-0.78;0.08]), suggesting expertise-driven assimilation of trial results. Similar findings were observed for the LION trial.

Conclusion Our analysis highlights the complex relationship between clinical trial findings and their application in clinical settings, revealing that academic and expertise levels significantly influence the adoption of new surgical practices. This study illustrates the necessity for tailored strategies to integrate clinical trial evidence effectively into gynecological oncology practices.

Disclosures None.

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