ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: survival and long-term safety
Objective - To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenanc...
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
April 2025
|
| In: |
Gynecologic oncology
Year: 2025, Jahrgang: 195, Pages: 192-199 |
| ISSN: | 1095-6859 |
| DOI: | 10.1016/j.ygyno.2025.03.018 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ygyno.2025.03.018 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0090825825000873 
|
| Verfasserangaben: | Ursula A. Matulonis, Jørn Herrstedt, Amit Oza, Sven Mahner, Andrés Redondo, Dominique Berton, Jonathan S. Berek, Charlotte A. Haslund, Frederik Marmé, Antonio González-Martín, Stéphanie Bécourt, Anna V. Tinker, Jonathan A. Ledermann, Benedict Benigno, Gabriel Lindahl, Nicoletta Colombo, Izabela A. Malinowska, Wenlei Liu, Manjinder Bains, Bradley J. Monk, Mansoor R. Mirza |
MARC
| LEADER | 00000naa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1928865976 | ||
| 003 | DE-627 | ||
| 005 | 20250623105245.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 250623s2025 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.ygyno.2025.03.018 |2 doi | |
| 035 | |a (DE-627)1928865976 | ||
| 035 | |a (DE-599)KXP1928865976 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Matulonis, Ursula A. |e VerfasserIn |0 (DE-588)1173942211 |0 (DE-627)1043741003 |0 (DE-576)515807516 |4 aut | |
| 245 | 1 | 0 | |a ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer |b survival and long-term safety |c Ursula A. Matulonis, Jørn Herrstedt, Amit Oza, Sven Mahner, Andrés Redondo, Dominique Berton, Jonathan S. Berek, Charlotte A. Haslund, Frederik Marmé, Antonio González-Martín, Stéphanie Bécourt, Anna V. Tinker, Jonathan A. Ledermann, Benedict Benigno, Gabriel Lindahl, Nicoletta Colombo, Izabela A. Malinowska, Wenlei Liu, Manjinder Bains, Bradley J. Monk, Mansoor R. Mirza |
| 264 | 1 | |c April 2025 | |
| 300 | |b Diagramme | ||
| 300 | |a 8 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Online veröffentlicht: 25. März 2025, Artikelversion: 25. März 2025 | ||
| 500 | |a Gesehen am 23.06.2025 | ||
| 520 | |a Objective - To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenance therapy beyond first progression, but overall survival (OS) analyses were limited by missing data. - Methods - Patients were randomized 2:1 to niraparib (300mg once daily) or placebo. A vital status check was extended to retrieve last-known-alive status for patients with missing survival data. Prespecified secondary efficacy outcomes (OS, chemotherapy-free interval [CFI], time to first subsequent therapy [TFST], PFS2, time to second subsequent therapy [TSST]) and safety are reported based on the extended data cutoff (March 31, 2021). - Results - Survival status was available for 97.6% (540/553) of randomized patients (germline BRCA [gBRCA]-mutated, 203; non-gBRCA-mutated, 350). Median OS with niraparib and placebo was 40.9 and 38.1months, respectively, in the gBRCA-mutated cohort (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.20) and 31.0 and 34.8months, respectively, in the non-gBRCA-mutated cohort (HR, 1.06; 95% CI, 0.81-1.37). Medians for CFI, TFST, PFS2, and TSST numerically favored niraparib in both cohorts. No new safety signals were detected. - Conclusions - OS did not significantly differ between treatment arms. Prespecified secondary efficacy endpoints numerically favored niraparib. Long-term safety remained consistent with the established niraparib safety profile. Taken together with the significant improvements in PFS observed in the primary analysis, these data support a favorable overall benefit-risk profile for niraparib in the recurrent OC maintenance setting. | ||
| 650 | 4 | |a Maintenance | |
| 650 | 4 | |a Niraparib | |
| 650 | 4 | |a Ovarian cancer | |
| 650 | 4 | |a Platinum sensitive recurrence | |
| 700 | 1 | |a Herrstedt, Jørn |e VerfasserIn |4 aut | |
| 700 | 1 | |a Oza, Amit |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mahner, Sven |e VerfasserIn |4 aut | |
| 700 | 1 | |a Redondo, Andrés |e VerfasserIn |4 aut | |
| 700 | 1 | |a Berton, Dominique |e VerfasserIn |4 aut | |
| 700 | 1 | |a Berek, Jonathan S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Haslund, Charlotte A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Marmé, Frederik |d 1974- |e VerfasserIn |0 (DE-588)132561972 |0 (DE-627)52394893X |0 (DE-576)299226549 |4 aut | |
| 700 | 1 | |a González-Martín, Antonio |e VerfasserIn |4 aut | |
| 700 | 1 | |a Bécourt, Stéphanie |e VerfasserIn |4 aut | |
| 700 | 1 | |a Tinker, Anna V. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Ledermann, Jonathan A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Benigno, Benedict |e VerfasserIn |4 aut | |
| 700 | 1 | |a Lindahl, Gabriel |e VerfasserIn |4 aut | |
| 700 | 1 | |a Colombo, Nicoletta |e VerfasserIn |4 aut | |
| 700 | 1 | |a Malinowska, Izabela A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Liu, Wenlei |e VerfasserIn |4 aut | |
| 700 | 1 | |a Bains, Manjinder |e VerfasserIn |4 aut | |
| 700 | 1 | |a Monk, Bradley J. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mirza, Mansoor R. |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Gynecologic oncology |d Orlando, Fla. : Academic Press, 1972 |g 195(2025) vom: Apr., Seite 192-199 |h Online-Ressource |w (DE-627)266881351 |w (DE-600)1467974-7 |w (DE-576)104193735 |x 1095-6859 |7 nnas |a ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer survival and long-term safety |
| 773 | 1 | 8 | |g volume:195 |g year:2025 |g month:04 |g pages:192-199 |g extent:8 |a ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer survival and long-term safety |
| 856 | 4 | 0 | |u https://doi.org/10.1016/j.ygyno.2025.03.018 |x Verlag |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u https://www.sciencedirect.com/science/article/pii/S0090825825000873 |x Verlag |z lizenzpflichtig |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20250623 | ||
| 993 | |a Article | ||
| 994 | |a 2025 | ||
| 998 | |g 132561972 |a Marmé, Frederik |m 132561972:Marmé, Frederik |d 60000 |d 61300 |d 50000 |e 60000PM132561972 |e 61300PM132561972 |e 50000PM132561972 |k 0/60000/ |k 1/60000/61300/ |k 0/50000/ |p 9 | ||
| 999 | |a KXP-PPN1928865976 |e 4737393355 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"id":{"doi":["10.1016/j.ygyno.2025.03.018"],"eki":["1928865976"]},"physDesc":[{"extent":"8 S.","noteIll":"Diagramme"}],"name":{"displayForm":["Ursula A. Matulonis, Jørn Herrstedt, Amit Oza, Sven Mahner, Andrés Redondo, Dominique Berton, Jonathan S. Berek, Charlotte A. Haslund, Frederik Marmé, Antonio González-Martín, Stéphanie Bécourt, Anna V. Tinker, Jonathan A. Ledermann, Benedict Benigno, Gabriel Lindahl, Nicoletta Colombo, Izabela A. Malinowska, Wenlei Liu, Manjinder Bains, Bradley J. Monk, Mansoor R. Mirza"]},"relHost":[{"title":[{"title":"Gynecologic oncology","title_sort":"Gynecologic oncology","subtitle":"an international journal ; official publication of the Society of Gynecologic Oncologists [u.a.]"}],"pubHistory":["1.1972/73 -"],"origin":[{"publisherPlace":"Orlando, Fla. ; Amsterdam [u.a.]","dateIssuedDisp":"1972-","publisher":"Academic Press ; Elsevier","dateIssuedKey":"1972"}],"note":["Gesehen am 12.02.20"],"disp":"ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer survival and long-term safetyGynecologic oncology","type":{"bibl":"periodical","media":"Online-Ressource"},"physDesc":[{"extent":"Online-Ressource"}],"recId":"266881351","id":{"eki":["266881351"],"issn":["1095-6859"],"zdb":["1467974-7"]},"corporate":[{"display":"Society of Gynecologic Oncology","role":"isb"}],"language":["eng"],"part":{"volume":"195","extent":"8","text":"195(2025) vom: Apr., Seite 192-199","year":"2025","pages":"192-199"}}],"recId":"1928865976","type":{"media":"Online-Ressource","bibl":"article-journal"},"title":[{"title_sort":"ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer","subtitle":"survival and long-term safety","title":"ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer"}],"note":["Online veröffentlicht: 25. März 2025, Artikelversion: 25. März 2025","Gesehen am 23.06.2025"],"origin":[{"dateIssuedDisp":"April 2025","dateIssuedKey":"2025"}],"language":["eng"],"person":[{"given":"Ursula A.","role":"aut","display":"Matulonis, Ursula A.","family":"Matulonis"},{"family":"Herrstedt","display":"Herrstedt, Jørn","role":"aut","given":"Jørn"},{"role":"aut","given":"Amit","display":"Oza, Amit","family":"Oza"},{"role":"aut","given":"Sven","family":"Mahner","display":"Mahner, Sven"},{"given":"Andrés","role":"aut","family":"Redondo","display":"Redondo, Andrés"},{"display":"Berton, Dominique","family":"Berton","role":"aut","given":"Dominique"},{"family":"Berek","display":"Berek, Jonathan S.","given":"Jonathan S.","role":"aut"},{"given":"Charlotte A.","role":"aut","display":"Haslund, Charlotte A.","family":"Haslund"},{"family":"Marmé","display":"Marmé, Frederik","given":"Frederik","role":"aut"},{"family":"González-Martín","display":"González-Martín, Antonio","given":"Antonio","role":"aut"},{"family":"Bécourt","display":"Bécourt, Stéphanie","given":"Stéphanie","role":"aut"},{"display":"Tinker, Anna V.","family":"Tinker","given":"Anna V.","role":"aut"},{"family":"Ledermann","display":"Ledermann, Jonathan A.","given":"Jonathan A.","role":"aut"},{"role":"aut","given":"Benedict","display":"Benigno, Benedict","family":"Benigno"},{"given":"Gabriel","role":"aut","family":"Lindahl","display":"Lindahl, Gabriel"},{"display":"Colombo, Nicoletta","family":"Colombo","role":"aut","given":"Nicoletta"},{"role":"aut","given":"Izabela A.","display":"Malinowska, Izabela A.","family":"Malinowska"},{"role":"aut","given":"Wenlei","display":"Liu, Wenlei","family":"Liu"},{"given":"Manjinder","role":"aut","display":"Bains, Manjinder","family":"Bains"},{"display":"Monk, Bradley J.","family":"Monk","given":"Bradley J.","role":"aut"},{"given":"Mansoor R.","role":"aut","family":"Mirza","display":"Mirza, Mansoor R."}]} | ||
| SRT | |a MATULONISUENGOTOV16N2025 | ||