{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T08:18:10Z","timestamp":1767687490474,"version":"3.48.0"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T00:00:00Z","timestamp":1767657600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"GSK Research & Development Limited"},{"DOI":"10.13039\/501100002839","name":"Charit\u00e9 - Universit\u00e4tsmedizin Berlin","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002839","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arch Gynecol Obstet"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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\u00a0days, with disease progression being the most common reason for discontinuation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00404-025-08295-x","type":"journal-article","created":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T08:15:44Z","timestamp":1767687344000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Between research and introduction to clinical routine\u2014Experience with niraparib from the compassionate use program in Germany (NOGGO Register Analysis)"],"prefix":"10.1007","volume":"313","author":[{"given":"Jacek P.","family":"Grabowski","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Welz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabine","family":"Heublein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maja","family":"Krajewska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jolijn D.","family":"Boer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabian","family":"Kraus","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tjadina","family":"Arndt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Moosmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernhard","family":"Heinrich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tobias","family":"Engler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saida","family":"Agabejli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mustafa Celalettin","family":"Ugur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ralf","family":"Witteler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oliver","family":"Albrecht","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harald","family":"M\u00fcller-Huesmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G\u00fclten","family":"Oskay-\u00d6zcelik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Hettwer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabrina","family":"Kaiser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Braicu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jalid","family":"Sehouli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2026,1,6]]},"reference":[{"key":"8295_CR1","unstructured":"Deutsches Krebsforschungszentrum (DKFZ) (2021) Ovarialkarzinom\u2014Inzidenz. 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In addition, the author has received travel and\/or meeting support from Abbvie and MSD.  SH reports receiving grants or contracts from Novartis, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis, Pfizer, Roche, Clovis, Abbvie, Daiichi Sankyo, Astra Zeneca, GSK, Eisai, Lilly, Immunogen, Gilead, MSD as well as support for attending meetings and\/or travel from Novartis and Pfizer. The author participated on a Data Safety Monitoring Board or Advisory Board from Novartis, Pfizer, Roche, Clovis, Astra Zeneca, GSK, Eisai, Lilly, MSD, Gilead. TA reports receiving support for attending meetings and\/or travel from AstraZeneca and AbbVie. BH reports receiving study fees from Novartis, Astra, Roche and support for attending meetings and\/or travel from Lilly. The author has participated in Advisory Boards from Roch, Novartis, Lilly and on a Data Safety Monitoring Board from Lilly.  TE reports receiving honoraria from AstraZeneca, Eli Lilly, Daiichi Sankyo, Gilead, GSK, MSD, Novartis, Pierre Fabre, Pfizer, Roche, and Stemline. The author has received travel and\/or meeting support from AbbVie, Daiichi Sankyo, GSK, Gilead, Eli Lilly, Pierre Fabre, and Novartis. The author has participated on a Data Safety Monitoring Board or Advisory Board for AstraZeneca, Eli Lilly, Gilead, GSK, MSD, Novartis, and Stemline. SA reports receiving honoraria from Novartis, Lilly, Stemline, and AstraZeneca. The author has received travel and\/or meeting support from Pierre Fabre, AstraZeneca, and AbbVie. The author has participated on a Data Safety Monitoring Board or Advisory Board for GSK, Novartis, AstraZeneca, and Stemline. HMH reports employment and\/or a leadership role at Christliches Klinikum Paderborn and MVZ Medico. The author has received consulting or advisory fees from Roche, BMS, Janssen, MSD, Astellas, AstraZeneca, Ipsen, Lilly, BeiGene, Stemline, Novartis, Pfizer, Daiichi-Sankyo, and Merck. The author has also received honoraria from these companies as well as from neo-connect GmbH and DocCheck. The author declares no ownership of stocks or shares, no patents or licenses, and no industry-sponsored research funding. RW reports receiving support for attending meetings and\/or travel from GSK. The author also participated on a Data Safety Monitoring Board or Advisory Board for MSD. GO reports receiving honoraria from Novartis, GlaxoSmithKline, Esteve, Pfizer, DaiichiSankyo, AstraZeneca, MSD, Gilead as well as support for attending meetings and\/or travel from Novartis, GlaxoSmithKline, DaiichiSankyo, AstraZeneca, AMGEN, MSD and Gilead. SK reports receiving honoraria from AstraZeneca as well as support for attending meetings and\/or travel from MSD and AstraZeneca.  EB reports receiving grants from AstraZeneca, Biontech, GSK, Immunogen\/AbbVie, TORL Bio, MSD, Eli Lilly and Company, NOGGO, Incyte, IQVIA, Roche. The author has received personal consulting fees from GSK, FirstWordGroup, Clarivate Analystics UK Limited, Windrose, Humanitas and personal honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, GSK, Immunogen\/AbbVie, MSD, NOGGO, Pharma&, Regeneron, TORL Bio, Tubulis, European Commission, QUIP, Discovery Life Sciences Biomarker Services. The author participated in advisory boards from AstraZeneca, GSK, Immunogen\/AbbVie, MSD, Myriad, Pharma&, Regeneron, TORL Bio, Tubulis. The author is also a member of Board of Directors, Medical Director of the study group NOGGO. JS reports receiving research funding from Roche Pharma, AstraZeneca, Bayer, Clovis Oncology, GlaxoSmithKline, Lilly, Iqvia, Mural, and MSD. The author has received honoraria from GlaxoSmithKline, PharmaMar, AstraZeneca, Clovis Oncology, Bayer, Roche Pharma, Vifor Pharma, Hexal AG, Novartis Pharma, Eisai, Esteve Pharmaceuticals, Incyte Biosciences, Phytolife Nutrition, JenaPharm, Kyowa Kirin, Oncoinvent AS, Daiichi, Medtronic Covidien, AMGEN, AbbVie, Corcept Therapeutics, Gilead Sciences, and Myriad. The author has also received consulting or advisory fees from Merck\/Pfizer, PharmaMar, Clovis Oncology, AstraZeneca, Roche Pharma, GlaxoSmithKline, MSD, Eisai, Novocure, Oncoinvent, Intuitive Surgical, Seagen, Bayer Vital, Mundipharma, Sanofi-Aventis Deutschland GmbH, Immunogen, Tubulis GmbH, Daiichi Sankyo, Bristol Myers Squibb, Karyopharm Therapeutics, and Corcept Therapeutics. All other authors have no relevant financial or non-financial interests to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interests"}}],"article-number":"11"}}