PMID- 38115203 OWN - NLM STAT- MEDLINE DCOM- 20240304 LR - 20240304 IS - 1447-0756 (Electronic) IS - 1341-8076 (Linking) VI - 50 IP - 3 DP - 2024 Mar TI - Increase in creatinine levels associated with niraparib maintenance therapy in ovarian cancer. PG - 501-507 LID - 10.1111/jog.15865 [doi] AB - AIM: In Japan, Niraparib maintenance therapy for primary and recurrent ovarian cancer was approved in September 2020 and is expected to improve the prognosis of ovarian cancer. However, the safety of niraparib maintenance therapy in Japanese patients has not been fully evaluated. METHODS: Patients with ovarian cancer (including fallopian tube and peritoneal cancer) treated with niraparib at Jichi Medical University Hospital from September 2020 to August 2022 were enrolled in this study. Patient background, starting dose, rates of interruption, reduction, or discontinuation, adverse events (AEs) during treatment, and estimated glomerular filtration rate (eGFR) trends were retrospectively analyzed. RESULTS: Twenty-nine patients received niraparib maintenance therapy during the study period, including 21 with primary cancer and 8 patients with recurrent cancer. Seventeen patients (58.6%) required dose interruptions and 16 patients (55.2%) required dose reductions. Only two patients (6.9%) discontinued treatment due to fatigue and nausea. The most frequent AE was creatinine increases in 18 patients (62.1%, all grades). Although eGFR levels decreased significantly after niraparib therapy compared to before niraparib therapy (59.3 vs. 50.3 mL/min/1.73 m(2) , p < 0.001), the levels returned to pre-niraparib initiation levels after discontinuation of niraparib (64.6 vs. 64.6 mL/min/1.73 m(2) , p = 0.96). Multivariate regression analysis showed that diabetes was independently associated with decreased eGFR (p = 0.013). CONCLUSIONS: Niraparib maintenance therapy frequently increased serum creatinine, but the change was reversible. Further studies are needed to determine the effects of niraparib on renal function in Japanese patients. CI - (c) 2023 Japan Society of Obstetrics and Gynecology. FAU - Takahashi, Yoshifumi AU - Takahashi Y AUID- ORCID: 0000-0003-3319-1205 AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Taguchi, Masahiro AU - Taguchi M AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Tamura, Kohei AU - Tamura K AUID- ORCID: 0000-0003-3278-7509 AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Shinohara, Miki AU - Shinohara M AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Koyanagi, Takahiro AU - Koyanagi T AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Takahashi, Suzuyo AU - Takahashi S AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Taneichi, Akiyo AU - Taneichi A AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Takei, Yuji AU - Takei Y AUID- ORCID: 0000-0002-1744-5570 AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Saga, Yasushi AU - Saga Y AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. FAU - Fujiwara, Hiroyuki AU - Fujiwara H AD - Department of Obstetrics and Gynecology, School of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. LA - eng PT - Journal Article DEP - 20231219 PL - Australia TA - J Obstet Gynaecol Res JT - The journal of obstetrics and gynaecology research JID - 9612761 RN - HMC2H89N35 (niraparib) RN - AYI8EX34EU (Creatinine) RN - 0 (Indazoles) RN - 0 (Piperidines) SB - IM MH - Female MH - Humans MH - Creatinine MH - Retrospective Studies MH - *Neoplasm Recurrence, Local MH - *Ovarian Neoplasms/drug therapy MH - *Indazoles MH - *Piperidines OTO - NOTNLM OT - creatinine increase OT - diabetes OT - eGFR OT - niraparib OT - ovarian cancer EDAT- 2023/12/20 06:42 MHDA- 2024/03/04 06:44 CRDT- 2023/12/20 00:30 PHST- 2023/06/26 00:00 [received] PHST- 2023/12/07 00:00 [accepted] PHST- 2024/03/04 06:44 [medline] PHST- 2023/12/20 06:42 [pubmed] PHST- 2023/12/20 00:30 [entrez] AID - 10.1111/jog.15865 [doi] PST - ppublish SO - J Obstet Gynaecol Res. 2024 Mar;50(3):501-507. doi: 10.1111/jog.15865. Epub 2023 Dec 19.