Introduction/Background*At initial diagnosis of ovarian cancer (OC), two third of patients have an advanced stage, accompanied by a 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 with advanced high-grade epithelial OC. The translation of these guidelines into the clinical routine affects drug as well as care management and therefore needs to be evaluated. This study aims to gain new insights into real-world biomarker testing, 1L treatment patterns together with outcomes of patients with newly diagnosed advanced OC in Germany and to capture the influence of 1L PARPi MTX on medical routine.
Methodology SCOUT-1 is a German prospective, non-interventional study (NCT04830709; NOGGO ov54) to collect clinical real-world and patient-reported outcome (PRO) data in patients newly diagnosed (first-line) with histologically confirmed advanced (FIGO stage III or IV) high-grade epithelial ovarian, fallopian-tube, or primary peritoneal cancer. Further eligibility 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. Approximately 750 adult eligible patients are planned to be included in up to 80 hospitals or office-based sites. The primary objective is to determine the effectiveness of standard treatment sequences by assessing progression-free survival according to investigator’s assessment and evaluation criteria used in routine clinical practice. Secondary goals are shown in figure 1. Further focus is to describe biomarker-testing algorithm, patient selection and to assess patients’ QoL, symptoms, needs as well as patients’ expectations. Importantly, the SCOUT-1 will help to collect long-term data as patients will be followed for up to 7 years. The study has been approved by ethics committees and recruitment is planned to start in Q2 2021. The estimated primary completion date is Q2 2032.
Sponsor AstraZeneca, in cooperation with North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
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