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#384 First interim analysis of the SCOUT-1 Study (NOGGO Ov54, NCT04830709): a non-interventional study to evaluate treatment patterns and longterm outcome in patients with newly diagnosed advances ovarian cancer
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  1. Klaus Pietzner1,2,
  2. Elena Ioana Braicu1,2,
  3. Pauline Wimberger3,2,
  4. Jessika Goldmann4,
  5. Karol Kubiak5,
  6. Nikolaus De Gregorio6,
  7. Julia Caroline Radosa7,
  8. Bahriye Atkas8,2,
  9. Angelika Ober9,
  10. Cosima Brucker10,
  11. Philipp Meyer-Wilmes11,2,
  12. Badrig Melekian12,
  13. Jacqueline Sagasser13,2,
  14. Dagmar Guth14,
  15. Andreas Schnelzer15,
  16. Svetlana Tchaikovski16,
  17. Hendrik Veldink17,2,
  18. Björn Lampe18 and
  19. Jalid Sehouli1,2
  1. 1Department of Gynecology European Competence Center for Ovarian Cancer, Campus Virchow-Klinikum, Charité Medical University, Berlin, Germany
  2. 2North-Eastern German Society of Gynecological Oncology (NOGGO), Berlin, Germany
  3. 3Department of Gynecology and Obstetrics, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany
  4. 4Department of Obstetrics and Gynecology, DRK Kliniken Berlin, Berlin, Germany
  5. 5Department of Obstetrics and Gynecology, St. Franziskus-Hospital, Münster, Germany
  6. 6Department of Obstetrics and Gynecology, SLK Kliniken, Heilbronn, Germany
  7. 7Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg Saar, Germany
  8. 8Department of Gynecology, University of Leipzig Medical Center, Leipzig, Germany
  9. 9Department of Obstetrics and Gynecology, St Vincenz Hospital Limburg, Limburg, Germany
  10. 10Paracelsus Medical University, University Women’s Hospital, Klinikum Nürnberg, Nürnberg, Germany
  11. 11Department of Gynecology and Obstetrics, University Hospital RWTH Aachen, Aachen, Germany
  12. 12Department of Obstetrics and Gynecology, St. Marien-Krankenhaus Siegen, Siegen, Germany
  13. 13Department of Gynecology and Obstetrics, University Hospital Augsburg, Augsburg, Germany
  14. 14Gynecologic Oncology, Praxis Dr. med. Dagmar Guth, Plauen, Germany
  15. 15RoMed Klinikum Rosenheim, Department of Obstetrics and Gynecology, Rosenheim, Germany
  16. 16Department of Gynecology and Obstetrics, Otto-Von-Guericke University, Magdeburg, Germany
  17. 17Department of Obstetrics and Gynecology, Stiftung Mathias-Spital Rheine, Rheine, Germany
  18. 18Department of Gynecology and Obstetrics, Florence Nightingale Hospital, Düsseldorf, Germany

Abstract

Introduction/Background The current standard of care for advanced ovarian cancer (OC) consists of upfront surgery, with the goal of complete macroscopic resection, followed by platinum-based chemotherapy and maintenance therapy (MTX) with poly(ADPribose) polymerase inhibitors (PARPi) or bevacizumab as monotherapy or in combination. The prospective, non-interventional SCOUT-1 study (NOGGO ov54, NCT04830709;) was initiated to assess treatment patterns and long-term outcome including the usage of the MTX and outcomes in patients with newly diagnosed advanced OC in Germany.

Methodology 750 Patients providing written informed consent, with completed surgery (if applicable), eligible for platinum-based chemotherapy, tested for BRCA1/2 mutations (solitary or within HRD-test) and willing/able to complete PROs electronically, are planned to be enrolled and followed for up to 7 years.The study is designed to analyze three cohorts of special interest (PARPi maintenance, bevacizumab maintenance, no maintenance). Interim analyses were defined at 175, 250 and 375 enrolled patients and followed for at least 3 months in order to assess the distribution across cohorts, safety and gain first insight into characteristics of patients.

Results Data from the first 175 patients enrolled in the study were used for first interim analysis (Data cut-off April 20th, 2023). Baseline characteristics, treatment patterns and safety will be presented stratified by cohorts of interest.

Conclusion The first SCOUT-1 data reflects current real-world practice and transfer from phase III trials into clinical routine. Future analysis should define the barriers to improve the quality of care.

Disclosures Sponsor:

AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, in cooperation with North-Eastern German Society of Gynecological Oncology (NOGGO e.V.). Medical writing assistance was provided by Dr. Katharina Bakhaus, Alcedis

GmbH, Giessen

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