SCOUT-1: Prospective non-interventional study in patients with BRCA/HRD-tested ovarian cancer (OC) eligible for first-line (1L) platinum-based chemotherapy (NOGGO ov54).

Abstract

TPS5608 Background: Two third of patients with OC, have an advanced stage at initial diagnosis accompanied with poor prognosis. Results from landmark trials of maintenance therapy (MTX) with poly ADP ribose polymerase inhibitors (PARPi), especially in tumors associated with homologous recombination deficiency (HRD), like BRCA-mutated tumors, led to the strong recommendation on testing and treatment procedures in the clinical routine in patients newly diagnosed with advanced high-grade epithelial OC. The translation of these guidelines into clinical routine affects care management and therefore needs to be evaluated. This study aims to gain new insights into current real-world biomarker testing and 1L-treatment patterns together with clinical and patient-reported outcomes of patients with newly diagnosed advanced OC in Germany and to capture the influence of 1L treatment (with or without PARPi MTX) on medical routine and patient needs. Methods: SCOUT-1 is a national prospective, observational study (NCT04830709) to collect clinical real-world and patient-reported outcome (PRO) data in patients newly diagnosed with histologically confirmed advanced (FIGO stage III or IV) high-grade epithelial ovarian, fallopian-tube, or primary peritoneal cancer in Germany. Selection criteria include written informed consent, completed surgery (if applicable), eligible for platinum-based chemotherapy, BRCA1/2 mutation tested and willingness/ability to report PROs electronically. About 750 patients are planned to be included in up to 80 sites (hospitals or office-based). The primary objective is to determine the effectiveness of standard treatment sequences by estimating progression-free survival according to investigator’s assessment. Further focus is to describe biomarker-testing algorithm, patient selection and to assess patients’ QoL, symptoms, needs, as well as patients’ expectations. Importantly, SCOUT-1 will help to collect long-term data as patients will be followed for up to 7 years. First-subject-was included in the study in June 2021. Study completion date is planned in Q2 2032.