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2022-RA-672-ESGO Comparison of quality of life in patients with platinum-sensitive recurrent ovarian, fallopian tube and peritoneal cancer treated with trabectedin plus pegylated liposomal doxorubicin (PLD) or standard platinum-based therapy: Data look of the NOGGO S16/COMPASS trial
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  1. Radoslav Chekerov1,2,
  2. Mustafa Deryal3,
  3. Bahriye Aktas4,
  4. Robert Röhle5,
  5. Annika Stürzebecher2,
  6. Marco J Battista6,
  7. Christian M Kurbacher7,
  8. Pauline Wimberger8,2,9,
  9. Ralf Lorenz10,
  10. Jana Barinoff11,
  11. Gunther Rogmans12,
  12. Jens Kosse13,
  13. Maximilian Klar14,
  14. Tomas Kupec15,
  15. Bernd Christensen16,
  16. Gülten Oskay-Özcelik17,2,
  17. Thomas Illmer18,
  18. Thorsten Götze19,
  19. Klaus Pietzner1,2 and
  20. Jalid Sehouli1,2
  1. 1Department of Gynecology with Center for Oncological Surgery, Charité-University Medicine of Berlin, Berlin, Germany
  2. 2Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie – NOGGO e.V., Berlin, Germany
  3. 3Department for Gynecology and Obstetrics, CaritasKlinikum Saarbrücken St. Theresia, Saarbrücken, Germany
  4. 4Klinik und Poliklinik für Frauenheilkunde, Universitätsklinikum Leipzig, Leipzig, Germany
  5. 5Institute of Biometry and Clinical Epidemiology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
  6. 6Department of Obstetrics and Gynecology, University Hospital Mainz, Mainz, Germany
  7. 7Gynäkologisches Zentrum Bonn, Bonn, Germany
  8. 8Technische Universität Dresden, Dresden, Germany
  9. 9Nationales Centrum für Tumorerkrankungen (NCT), Dresden, Germany
  10. 10Studien GbR Braunschweig, Braunschweig, Germany
  11. 11Sankt Gertrauden Krankenhaus, Berlin, Germany
  12. 12ZAGO – am Helios Klinikum Krefeld, Krefeld, Germany
  13. 13Sana Klinikum Offenbach, Offenbach, Germany
  14. 14Klinik für Frauenheilkunde, Universitätsklinikum Freiburg, Freiburg, Germany
  15. 15Klinik für Gynäkologie und Geburtshilfe RWTH Aachen, Universitätsklinikum Aachen, Aachen, Germany
  16. 16Klinik für Gynäkologie und Geburtshilfe, ukrb – Universitätsklinikum Ruppin-Brandenburg, Neuruppin, Germany
  17. 17Praxis für Krebsheilkunde, Berlin, Germany
  18. 18Oncology Praxis – BAG, Dresden, Germany
  19. 19Institut für Klinisch-Onkologische Forschung (IKF), Krankenhaus Nordwest, Frankfurt, Germany

Abstract

Introduction/Background Despite recent progress regarding surgical and medical management of primary ovarian cancer, relapses are still frequent and one of the most critical challenges in the clinical routine. There is a broad consensus that quality of life (QoL) should be one of the most relevant goals of any therapy in relapsed ovarian cancer.

Methodology We report the results of a data look of the multicentre, randomized (1:1), active-controlled, open-label phase IV NOGGO-S16/COMPASS trial performed in patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer. The scope of this trial is to evaluate QoL with EORTC QLQ-C30 and QLQ-OV28 questionnaires during/after chemotherapy either with platinum/taxane-free combination of trabectedin (Yondelis®) plus PLD or with standard platinum-based chemotherapy comprising combination of carboplatin with PLD, gemcitabine or paclitaxel. The current data look serves to characterise the included patient population.

Results Data from 76 patients screened have been analysed. Patients have a median age of 63 years (range: 21–82), the performance status score of 0/1 was recorded in 75 patients (98.7%), and most are BRCA-negative (77.4%). They are diagnosed with primary ovarian carcinoma (83.6%), primary peritoneal carcinoma (9.6%) and fallopian carcinoma (6.8%), and 79% of patients have a grade 3 histopathological staging. Poly (ADP-ribose) polymerase inhibitors or bevacizumab were given as prior maintenance therapy to 15.3% and 76.4% of patients, respectively. Overall, 60% of patients had a platinum-free interval of >12 months before randomization and 45.8% of patients finished COMPASS trial as per protocol. The main reasons for withdrawal were progression under treatment (18.6%), toxicity (15.3%), death (13.6%) and patient wish (6.8%). Post-protocol maintenance therapy was given to 23.8% of patients. No differences in patient characteristics were observed.

Conclusion Based on this data look no significant signal for a non-inferiority of the study arms have been observed. Study is ongoing and open for recruitment.

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