{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T10:16:27Z","timestamp":1785838587794,"version":"3.56.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,12,14]],"date-time":"2024-12-14T00:00:00Z","timestamp":1734134400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GSK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,1,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Maintenance niraparib at an individualized starting dose (ISD) is established in platinum-sensitive recurrent ovarian cancer (PSROC). However, patients\u2019 perspectives on the burden of prolonged maintenance therapy have not been reported in prospective trials or routine practice.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In the real-life multicenter NiQoLe study, patients with PSROC received ISD maintenance niraparib. The primary objective was to describe physician-reported adverse events (AEs) leading to treatment modification during the first 3\u2009months. Secondary endpoints included patient-reported outcomes (symptomatic AEs using PRO-CTCAE, self-reported fatigue, and impact on daily activities\/function using FACT-F) collected remotely weekly using a specifically designed electronic device.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Most (80%) of 139 treated patients (median age = 70\u2009years) began niraparib at 200\u2009mg\/day. Median treatment duration was 5.7 (range = 0.2-21.4) months. During the first 3\u2009months, 86 patients (62%) required treatment modification (median = 27\u2009days to modification). Physician-reported grade \u22653 niraparib-related AEs occurred in 34 patients (24%); 68 patients (49%) had treatment modification for AEs, predominantly thrombocytopenia. The most frequent patient-reported AEs (PRO-CTCAE) were fatigue, insomnia, constipation, and dry mouth. Self-reported AEs were severe in 66% of patients. At baseline, 33% of patients reported severe fatigue (FACT-F), which generally persisted during niraparib. Physicians systematically underestimated major patient-reported symptoms.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In routine practice, niraparib dose modification was often required during the first 3\u2009months despite individualized dosing. Physicians underestimated the burden of fatigue and symptomatic AEs. Digital self-reporting of AEs is feasible, provides patient-centered information complementing physician-reported AEs, and allows fuller appreciation of toxicity in real-world studies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial information<\/jats:title>\n                  <jats:p>NCT03752216<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jncics\/pkae114","type":"journal-article","created":{"date-parts":[[2024,12,14]],"date-time":"2024-12-14T22:02:40Z","timestamp":1734213760000},"source":"Crossref","is-referenced-by-count":4,"title":["Improving real-world evaluation of patient- and physician-reported tolerability: niraparib for recurrent ovarian cancer (NiQoLe)"],"prefix":"10.1093","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7004-9895","authenticated-orcid":false,"given":"Florence","family":"Joly","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Centre Fran\u00e7ois Baclesse, University Unicaen , Caen,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Bazan","sequence":"additional","affiliation":[{"name":"Department of Oncology, CHRU Besan\u00e7on\u2014H\u00f4pital Jean Minjoz , Besan\u00e7on,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Garbay","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Clinique Tivoli-Ducos , Bordeaux,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaelle","family":"Ouldbey","sequence":"additional","affiliation":[{"name":"Department of Clinical Research and Innovation, Centre L\u00e9on-B\u00e9rard , 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Nimes,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre-Emmanuel","family":"Brachet","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Centre Fran\u00e7ois Baclesse, University Unicaen , Caen,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Spaeth","sequence":"additional","affiliation":[{"name":"Medical Oncology Department, Centre d\u2019Oncologie de Gentilly , Nancy,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7321-7345","authenticated-orcid":false,"given":"Pierre","family":"Combe","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, P\u00f4le Sant\u00e9 L\u00e9onard de Vinci , 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