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This non-interventional, register-based CUP study in Germany evaluated dose modifications, safety, tolerability, adverse events, and quality of life in platinum-sensitive recurrent cases across 14 centers, using descriptive analyses. Findings indicate a favorable real-world safety and tolerability profile, supporting niraparib effectiveness for recurrent ovarian cancer.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/between-research-and-introduction-to-clinical-routineexperience-with-niraparib-from-the-compassionate-use-program-in-germany-noggo-register-analysis/455543/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/between-research-and-introduction-to-clinical-routineexperience-with-niraparib-from-the-compassionate-use-program-in-germany-noggo-register-analysis/455543.png","ImageObject",300,407,{"name":92,"@type":93},"Hazel","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-10","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":29},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the main purpose of this study on niraparib in Germany?","Question",{"text":112,"@type":113},"To evaluate dose modifications, safety, tolerability, and quality-of-life impact of niraparib in real-world clinical practice for patients treated through the compassionate-use program.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was the study designed and where were data collected?",{"text":117,"@type":113},"It was a non-interventional, register-based study including platinum-sensitive recurrent ovarian cancer patients receiving niraparib in the German CUP. Data on baseline characteristics, treatment, adverse events, and quality-of-life measures were collected prospectively and retrospectively across 14 centers.",{"name":119,"@type":110,"acceptedAnswer":120},"What adverse events were most commonly associated with niraparib, and what influenced their frequency?",{"text":121,"@type":113},"The most frequently reported adverse events were thrombocytopenia, fatigue, and nausea. Adverse events were less common in patients with normal physical examination findings, better ECOG performance status, and absence of comorbidities, while prior PARP inhibitor use or prior treatment-related side effects increased the likelihood.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},455543,1791104942,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":29,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":52,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144,"preview_page_count":4},137441390410,"https://ap-avatar.wpscdn.com/avatar/2000252f4ab5702993?_k=1776741390130283984","Archives of Gynecology and Obstetrics (2026) 313:11  \n[https://doi.org/10.1007/s00404-025-08295-x](https://doi.org/10.1007/s00404-025-08295-x)  \nBetween research and introduction to clinical routine—Experience with niraparib from the compassionate use program in Germany (NOGGO Register Analysis)  \nJacek P. Grabowski1,2 · Julia Welz3 · Sabine Heublein4,5 · Maja Krajewska6 · Jolijn D. Boer2 · Fabian Kraus7 · Tjadina Arndt1 · Nicolas Moosmann8 · Bernhard Heinrich9 · Tobias Engler10 · Saida Agabejli11 ·  \nMustafa Celalettin Ugur12 · Ralf Witteler13 · Oliver Albrecht14 · Harald Müller‑Huesmann15 · Gülten Oskay‑Özcelik16,2 · Cristina Hettwer17 · Sabrina Kaiser3 · Elena Braicu1,2 · Jalid Sehouli1,2  \nReceived: 11 September 2025 / Accepted: 21 October 2025 © The Author(s) 2025  \nAbstract  \nPurpose Ovarian cancer (OC) is frequently diagnosed at a late, advanced stage, resulting in poor survival outcomes. PARP inhibitors like niraparib have shown significant efficacy in high-grade OC, particularly in tumors with homologous recombination deficiency, including BRCA mutations. This study aimed to evaluate dose modifications, safety, tolerability, and the impact on quality of life associated with niraparib in real-world clinical practice.  \nMethods This non-interventional, register-based study included patients with platinum-sensitive recurrent OC who received niraparib as part of the compassionate-use program (CUP) in Germany. Clinical baseline characteristics, treatment data, adverse events (AEs), and quality-of-life measures were collected both prospectively and retrospectively across 14 centers. Data analysis was performed using descriptive statistical methods.  \nResults Overall, 68 female patients were enrolled in the CUP register. Most patients had good performance status, with no significant comorbidities or concomitant medications. The most frequently reported AEs associated with niraparib were thrombocytopenia, fatigue, and nausea. Approximately half of patients required dose adjustments. AEs were less common in patients with normal physical examination findings, better ECOG performance status, and absence of comorbidities. Prior use of PARP inhibitors or previous treatment-related side effects increased the likelihood of AEs during niraparib therapy. The median treatment duration was 182 days, with disease progression being the most common reason for discontinuation. Conclusion Niraparib treatment within the German CUP demonstrated favorable safety and tolerability profiles, supporting its effectiveness in a real-world setting for patients with recurrent OC. These findings are consistent with results from clinical trials, further reinforcing the role of niraparib in this patient population.  \nKeywords PARP-Inhibitor · CUP · Clinical experience · Ovarian cancer · Real-world  \nWhat does this study adds to the clinical work  \nThis manuscript presents real-world evidence supporting the safety and tolerability of niraparib inpatients with recurrent ovarian cancer, complementing findings from clinical trials. It identifies key factors associated with adverse event rates and emphasizes the practical importance of dose adjustmentsin routine clinical practice.  \nIntroduction  \nIn Germany, approximately 7000 new cases of ovarian cancer are diagnosed annually. Due to the lack of specific symptoms and limitations of current screening methods, most patients are diagnosed at advanced stages, which significantly impacts survival rates [1] . In FIGO (International Federation of Gynecological Oncology) stages III and IV epithelial ovarian cancer, the 5-year survival rates are approximately 41% and 20%, respectively [2] . The standard treatment for ovarian cancer involves surgery aimed at achieving complete tumor resection, followed by platinum-based chemotherapy and subsequent  \nmaintenance therapy. However, approximately 70% of patients with advanced-stage ovarian cancer experience disease recurrence [3] .  \nThe historical definition of platinum ","cbCaimpuKjpa4ZU5","https://ap.wps.com/l/cbCaimpuKjpa4ZU5","pdf",751669,"English","# Abstract\n## Purpose\n## Methods\n## Results\n## Conclusion\n# What does this study add to the clinical work\n# Introduction\n## Disease burden and screening limitations\n## Platinum sensitivity and therapy-free interval framework\n## BRCA/HRR biology and treatment implications\n## Mechanism of niraparib and evidence background","[{\"question\":\"What was the main purpose of this study on niraparib in Germany?\",\"answer\":\"To evaluate dose modifications, safety, tolerability, and quality-of-life impact of niraparib in real-world clinical practice for patients treated through the compassionate-use program.\"},{\"question\":\"How was the study designed and where were data collected?\",\"answer\":\"It was a non-interventional, register-based study including platinum-sensitive recurrent ovarian cancer patients receiving niraparib in the German CUP. Data on baseline characteristics, treatment, adverse events, and quality-of-life measures were collected prospectively and retrospectively across 14 centers.\"},{\"question\":\"What adverse events were most commonly associated with niraparib, and what influenced their frequency?\",\"answer\":\"The most frequently reported adverse events were thrombocytopenia, fatigue, and nausea. Adverse events were less common in patients with normal physical examination findings, better ECOG performance status, and absence of comorbidities, while prior PARP inhibitor use or prior treatment-related side effects increased the likelihood.\"}]","Between research and introduction to clinical routine—Experience with niraparib from the compassionate use program in Germany (NOGGO Register Analysis) | PDF",1790743373,25]