Article Text
Abstract
Introduction/Background The prospective, non-interventional study SCOUT-1 (NCT04830709; NOGGO ov54) evaluates real-world management of patients with primary advanced (FIGO stage III or IV) high-grade epithelial ovarian cancer (OC) to assess the effectiveness of standard treatment sequences used in routine clinical practice in Germany with focus on patients´ needs and health-related quality of life.
Methodology As described earlier, all initiated sites are asked once a year to provide cumulative data on their patients treated for OC. Additionally, site characteristics such as type, and certification were collected. Data analysis was done in a descriptive and explorative manner using appropriate statistical methods.
Results Out of 73 sites initiated by March 2023 55 sites provided their characteristics. Most sites are full-service hospitals (64%), 20% base service hospitals and 16% office-based gynecological sites. Most of the sites are certified from German Cancer Society as (gyneco)oncological centers (89%).
Cumulative data for 2022 were provided by 44 sites (35 also took part on last year questioning). Overall 24 patients with newly diagnosed OC were in mean treated by the sites in 2022 (range 5–96 patients). 14% of the sites treated < 1 patient/month, 59% 1–2 patients/month and 25% >2 patients/month. The sites mainly diagnosed advanced stage FIGO III or IV (72.0%), serous histology (71.0%) and high-grade carcinoma (72%). Cyto-reductive surgery was performed in 75.0% of the reported cases. Most of the patients received (72%) and if received, responded well to platinum-based chemotherapy (77%).
Conclusion Analysis of site specific, cumulative data showed similarity to other epidemiological sources in Germany. Compared to 2021 cumulative mean number of patients with newly diagnosed OC remains stable, even if there were some changes on a site level. Data from 2022 continues to support that a representative cohort of OC patients will be enrolled in the SCOUT-1 study.
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