PMID- 33993885 OWN - NLM STAT- MEDLINE DCOM- 20211119 LR - 20240402 IS - 1757-2215 (Electronic) IS - 1757-2215 (Linking) VI - 14 IP - 1 DP - 2021 May 17 TI - The efficacy and safety of niraparib for ovarian cancer: a single-center observational study from China. PG - 68 LID - 10.1186/s13048-021-00803-2 [doi] LID - 68 AB - BACKGROUND: Niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for first/second-line maintenance treatment of ovarian cancer patients with complete or partial response to platinum-based chemotherapy, and multi-line monotherapy in BRCAmt patients or platinum-sensitive recurrence patients with homologous recombination deficiency (HRD). We present real-world experience from a single center of China. METHODS: Patients treated with niraparib in Jiangsu Cancer Hospital between June 2019 to July 2020 were recruited. The initial dose was given according to individualization. Response and adverse events (AEs) were analyzed by Response Evaluation Criteria in Solid Tumors v1.1. and National Cancer Institute Common Terminology Criteria for Adverse Events v5.0, respectively. HRD testing (AmoyDx(R)) was detected in most patients. Treatment was given until unequivocal progression or intolerable toxicity. RESULTS: Twenty-two patients all received niraparib at a bolus of 200 mg/d. Fifty percent of patients with high-grade serous ovarian cancer are HRD-positive. Six patients underwent first-line maintenance therapy. Sixteen patients received exploratory therapy. Ultimately image evaluation revealed that two patients achieved partial response (PR) and one patient achieved stable disease (SD), yielding objective response rate (ORR) of 33.3% (95%CI = 0.060-0.759) and disease control rate (DCR) of 50% (95%CI = 0.140-0.861) in the exploratory multi-line monotherapy group. The most common AEs were nausea, thrombocytopenia, and anemia. Grade 3-4 thrombocytopenia were managed by dose reduction and interruption. Leg swelling was observed as a new adverse event. CONCLUSION: It is feasible that patients receiving a bolus of 200 mg/d in patients from Chinese population can acquire promising efficacy and tolerance. This is the first real-world data about niraparib in ovarian cancer patients with available HRD status from China. FAU - Ni, Jing AU - Ni J AD - Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. FAU - Cheng, Xianzhong AU - Cheng X AD - Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. FAU - Zhao, Qian AU - Zhao Q AD - Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. FAU - Dai, Zhiqin AU - Dai Z AD - Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. FAU - Xu, Xia AU - Xu X AD - Department of Chemotherapy, Nanjing Medical University Affiliated Cancer Hospital, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. FAU - Guo, Wenwen AU - Guo W AD - Department of Pathology, The Second Affiliated Hospital of Nanjing Medical University, 121# Jiangjiayuan Road, Nanjing, Jiangsu, 210011, People's Republic of China. FAU - Gu, Hongyuan AU - Gu H AD - Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. FAU - Zhou, Rui AU - Zhou R AD - Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. FAU - Wang, Yan AU - Wang Y AD - Department of Pathology, The Second Affiliated Hospital of Nanjing Medical University, 121# Jiangjiayuan Road, Nanjing, Jiangsu, 210011, People's Republic of China. wangyan_9999@sina.com. FAU - Chen, Xiaoxiang AU - Chen X AUID- ORCID: 0000-0002-2400-4749 AD - Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China. cxxxxcyd@gmail.com. LA - eng GR - 81472441/National Natural Science Foundation of China/ GR - 81501205/National Natural Science Foundation of China/ GR - KH-2020-LJJ-021/Beijing Kanghua Foundation for the Development of Traditional Chinese and Western Medicine -Le Fund/ GR - No. ZM201804/Institute level project of Jiangsu Cancer Hospital/ GR - F202004/Jiangsu Province Maternal and Child Health Research Project/ PT - Journal Article DEP - 20210517 PL - England TA - J Ovarian Res JT - Journal of ovarian research JID - 101474849 RN - 0 (Indazoles) RN - 0 (Piperidines) RN - 0 (Poly(ADP-ribose) Polymerase Inhibitors) RN - HMC2H89N35 (niraparib) SB - IM MH - Adult MH - Aged MH - China MH - Female MH - Humans MH - Indazoles/pharmacology/*therapeutic use MH - Middle Aged MH - Ovarian Neoplasms/*drug therapy/pathology MH - Piperidines/pharmacology/*therapeutic use MH - Poly(ADP-ribose) Polymerase Inhibitors/pharmacology/*therapeutic use PMC - PMC8127179 OTO - NOTNLM OT - Efficacy OT - HRD OT - Niraparib OT - Ovarian cancer OT - Real world OT - Safety COIS- The authors declare that they have no competing interests. EDAT- 2021/05/18 06:00 MHDA- 2021/11/20 06:00 PMCR- 2021/05/17 CRDT- 2021/05/17 05:33 PHST- 2020/10/31 00:00 [received] PHST- 2021/04/05 00:00 [accepted] PHST- 2021/05/17 05:33 [entrez] PHST- 2021/05/18 06:00 [pubmed] PHST- 2021/11/20 06:00 [medline] PHST- 2021/05/17 00:00 [pmc-release] AID - 10.1186/s13048-021-00803-2 [pii] AID - 803 [pii] AID - 10.1186/s13048-021-00803-2 [doi] PST - epublish SO - J Ovarian Res. 2021 May 17;14(1):68. doi: 10.1186/s13048-021-00803-2.