AGO-OVAR 28/ENGOT-ov57. Niraparib alone versus niraparib in combination with bevacizumab in patients with carboplatin-taxane-based chemotherapy in advanced ovarian cancer: A multicenter randomized phase III trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Florian Heitz - , University of Duisburg-Essen (Author)
  • Christian Marth - , Innsbruck Medical University (Author)
  • Stéphanie Henry - , Centre Hospitalier Universitaire UCL Namur (Author)
  • Alexander Reuss - , University of Marburg (Author)
  • David Cibula - , Charles University Prague (Author)
  • Lydia Gaba Garcia - , University of Barcelona (Author)
  • Nicoletta Colombo - , University of Milan - Bicocca (Author)
  • Barbara Schmalfeld - , University of Hamburg (Author)
  • Nikolaus De Gregorio - , SLK-Kliniken Heilbronn GmbH (Author)
  • Pauline Wimberger - , Department of Gynecology and Obstetrics (Author)
  • Annette Hasenburg - , Johannes Gutenberg University Mainz (Author)
  • Jalid Sehouli - , Charité – Universitätsmedizin Berlin (Author)
  • Martina Gropp-Meier - , Oberschwabenklinik Ravensburg (Author)
  • Philip C. Schouten - , University of Cologne (Author)
  • Eric Hahnen - , University of Cologne (Author)
  • Jan Hauke - , University of Cologne (Author)
  • Sandra Polleis - , AGO Research GmbH (Author)
  • Philipp Harter - , University of Duisburg-Essen (Author)

Abstract

Background: Phase III trial data have shown a significant benefit by the addition of a maintenance treatment with niraparib, irrespective of BRCA or HRD status, in patients with advanced high-grade ovarian cancers; and, a significant benefit of the combination of olaparib and bevacizumab compared with bevacizumab monotherapy in HRD positive patients. However, it is unclear whether a PARP inhibitor monotherapy is sufficient, or if the addition of bevacizumab is needed. Primary Objectives: This trial will investigate if the treatment strategy of carboplatin/paclitaxel/bevacizumab/niraparib is superior to the treatment of carboplatin/paclitaxel/niraparib in an all-comer population. Study Hypothesis: Adding bevacizumab to chemotherapy followed by niraparib maintenance improves progression-free survival in patients with newly diagnosed advanced ovarian cancer. Trial Design: AGO-OVAR 28/ENGOT-ov57 is an international, multicenter, randomized, prospective phase III trial within the the European Network for Gynecological Oncological Trial (ENGOT), led by the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study group. All patients should have completed the first cycle of chemotherapy (carboplatin and paclitaxel) as part of the Study Run-In-Period. Prior to day 1 of cycle 2, patients with a valid central tumor BRCA (tBRCA) test result were randomized in a 1:1 ratio into either: Arm 1, to receive five additional cycles of carboplatin and paclitaxel q21d, followed by niraparib for up to 3 years; or Arm 2, to receive five additional cycles of carboplatin and paclitaxel plus bevacizumab q21d, followed by bevacizumab q21d (for up to 1 year), and niraparib for up to 3 years. Major Inclusion/Exclusion Criteria: The trial population is composed of adult patients with newly diagnosed, advanced high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO IIIA2 without nodal involvement). Patients who are scheduled for neoadjuvant chemotherapy and interval debulking surgery are also eligible for the trial. Primary Endpoint: The primary endpoint is progression-free survival. Sample Size: The study plans to recruit 970 patients (485 patients in each arm). Estimated Dates For Completing Accrual And Presenting Results: The Last-Patient-In is expected to be enrolled in September 2024, with presentation of the primary endpoint in 2028.

Details

Original languageEnglish
Article numberijgc-2023-004944
Pages (from-to)1966-1969
Number of pages4
JournalInternational journal of gynecological cancer
Volume33
Issue number12
Publication statusPublished - 7 Nov 2023
Peer-reviewedYes

External IDs

PubMed 37935524

Keywords

Sustainable Development Goals

ASJC Scopus subject areas

Keywords

  • Ovarian Cancer, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Prospective Studies, Humans, Carcinoma, Ovarian Epithelial/drug therapy, Paclitaxel, Carboplatin, Adult, Female, Bevacizumab, Ovarian Neoplasms/pathology