Article Text
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