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#172 STREAM-I/AGO-OP.11/ENGOT-En22: evaluation of preoperative clinical and translational selection criteria for cytoreductive surgery in endometrial cancer – step 1 of the stream (surgical treatment in advanced and recurrent endometrial cancer management) initiative
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  1. Fabian Trillsch1,
  2. Lorenzo Ceppi2,
  3. Pierre-Emmanuel Colombo3,
  4. Alexander Reuß4,
  5. Dana Josephy5,
  6. Joanna Kacperczyk-Bartnik6,
  7. Zoia Razumova7,
  8. Aleksandra Strojna8,
  9. Oleksandr Zub9,
  10. Jalid Sehouli10,
  11. Christian Marth11,
  12. Sven Mahner1,
  13. Philipp Harter12,
  14. Christoph Grimm13 and
  15. Alexandra Wagner10
  1. 1AGO and Department of Obstetrics and Gynecology, LMU University Hospital, LMU Munich LMU University Hospital, LMU Munich, Munich, Germany
  2. 2MaNGO and Gynecology and Obstetrics Department, Grande Ospedale Metropolitano Niguarda, Milano, Italy
  3. 3GINECO and Department of Surgical Oncology, Montpellier Cancer Institute (ICM), Montpellier, France
  4. 4AGO and Coordinating Center for Clinical Trials of the Philipps-University of Marburg, Marburg, Germany
  5. 5ISGO and Gynecology-Oncology Unit, Sheba Medical Center, Tel-Aviv, Israel
  6. 6PGOG and Departament of Obstetrics and Gynecology, Medical University of Warsaw, Warsaw, Poland
  7. 7NSGO-CTU and Department of Women’s and Children’s Health, Karolinska University Hospital, Stockholm, Sweden
  8. 8CEEGOG and Department of Gynecology and Gynecologic Oncology, Evangelische Kliniken Essen Mitte, Essen, Germany
  9. 9CEEGOG and Clinical oncology and gynecology department, Chernihiv medical center of modern oncology, Chernihiv, Ukraine
  10. 10NOGGO and Department of Gynecology with Center for Oncological Surgery, Charité Gynecologcial Cancer Center and European Competence Center for Ovarian Cancer, Berlin, Germany
  11. 11AGO-Austria and Department of Obstetrics and Gynaecology, Innsbruck Medical University, Innsbruck, Austria
  12. 12AGO and Department of Gynecology and Gynecologic Oncology, Evangelische Kliniken Essen-Mitte, Essen, Germany
  13. 13AGO-Austria and Division of General Gynecology and Gynecological Oncology, Gynecologic Cancer Unit, Medical University Vienna, Vienna, Austria

Abstract

Introduction/Background Endometrial cancer (EC) is the most common gynecological cancer in Europe with approximately 20% of patients being diagnosed in advanced stage (FIGO III-IV). Until now, only few studies exist for cytoreductive surgery (CRS) in advanced stage reporting of complete cytoreduction in 18–75% cases. Evidence for EC from large multicenter analyses data is missing and the indication for CRS is widely based on individual and/or institutional decision algorithms.

Methodology STREAM-I/AGO-OP.

11/ENGOT-en22 is a retrospective, non-interventional, multicenter study aiming to identify preoperative clinical and molecular selection criteria for CRS. Patients who underwent CRS for advanced or recurrent EC at participating centers between 01/2011 and 12/2020 will be included. Available tumor material from CRS will be collected for evaluation of molecular classification and translational research. A multiple logistic regression identifying predictive factors for complete resection at CRS will be established using a stepwise covariate selection in the full clinical dataset. Therefore, a sample size of 800 patients was calculated based on estimated complete resection rates and number of independent variables.

Results As a result of this analysis, STREAM-II is planned as a consecutive prospective, single-arm, non-interventional, multicenter trial validating the predictive score established within the present study. Following confirmation, STREAM-III is planned to be a randomized, multicenter phase III trial evaluating CRS in EC.

Conclusion STREAM-I represents the first step towards Level I evidence for CRS in EC by identifying patients who most likely benefit from a radical surgical approach. STREAM-I will provide information to develop consecutive trials prospectively evaluating the impact of CRS in EC (STREAM-II/-III).

Disclosures No direct conflict of interest for this surgical trial exists. Further relation to companies have been disclosed and uploaded.

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