Real-world data from a multi-center study: Insights to the efficacy and safety in patients with ovarian cancer (OC) received niraparib as first-line (1st-L) maintenance therapy (MT).

person Minmin Zhao Department of Obstetrics and Gynecology, Zhongda Hospital Southeast University, Nanjing, China info_outline Minmin Zhao, Yang Shen, Ying Zhou, Bingwei Chen, Xin Wu, Pengcheng Miao, Zhi Jiang, Tao Zhu, Xizhong Xu, Bei Zhang, Donglan Yuan, Yang Zhang, Wei Sun, Aiqin He, Min Zhao, Wenjie Hou, Zhuyan Shao, Meiqun Jia, Yanling Zhu, Jun Chen

Authors person Minmin Zhao Department of Obstetrics and Gynecology, Zhongda Hospital Southeast University, Nanjing, China info_outline Minmin Zhao, Yang Shen, Ying Zhou, Bingwei Chen, Xin Wu, Pengcheng Miao, Zhi Jiang, Tao Zhu, Xizhong Xu, Bei Zhang, Donglan Yuan, Yang Zhang, Wei Sun, Aiqin He, Min Zhao, Wenjie Hou, Zhuyan Shao, Meiqun Jia, Yanling Zhu, Jun Chen Organizations Department of Obstetrics and Gynecology, Zhongda Hospital Southeast University, Nanjing, China, Department of Obstetrics and Gynaecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China, China, Department of Obstetrics and Gynecology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China, Department of Epidemiology and Biostatistics, School of Public health, Southeast University, Nanjing, -, China, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China, Department of Epidemiology and Biostatistics, School of Public health, Southeast University, Nanjing, China, Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Insititute of Cancer Research, The Affilated Cancer Hospital of Nanjing Medical University, Nanjing, China, Department of Gynecological Oncology, Zhejiang Cancer Hospital, Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou, China, Department of Gynecology,Affiliated Hospital of Jiangnan University, Wuxi, China, Department of Obstetrics and Gynaecology, Xuzhou Central Hospital, Xuzhou, China, Department of Gynecological Oncology, The Affiliated Taizhou People's Hospital of Nanjing Medical University, Taizhou, China, Department of Gynecology,Lianyungang First People's Hospital, Lianyungang, China, Department of Gynecology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China, Affiliated Tumor Hospital of Nantong University, Nantong, China, Department of Gynecological Oncology, Wuxi Maternal and Child Health Hospital, Wuxi School of Medicine, Jiangnan University, Wuxi, China, Department of Obstetrics and Gynecology, Dushu Lake Hospital Affiliated to Soochow University, Suzhou, China, Department of Gynecological Oncology, Zhejiang Cancer Hospital, Institute of Basic Medicine and Cancer, Hangzhou, China, Department of Gynecology Oncology, Nantong Tumor Hospital, Nantong, China, Department of Gynecology Oncology, Xuzhou Cancer Hospital, Xuzhou, China, Zai Lab Limited, Wuhan, China Abstract Disclosures Research Funding Other Foundation Beijing Science & Technology Innovation Fund (KC2021-JX-0186-143) Background: Niraparib has significantly extended PFS as 1st-L MT OC in PRIMA/PRIME. Due to the more complex in treatment and status of the patients (pts) in clinal practice, more real-world data is needed to verify the efficacy and safety of Niraparib. Meanwhile, exploring the link between clinical characters and PFS, may to establish a clinical model to predict Niraparib benefits. Methods: This is a retrospective multicentric study recruiting OC pts received Niraparib as 1st-L MT from fourteen hospitals throughout China from Jan. 2019 to Dec. 2021. The database lock-time was on Dec. 31st, 2022. The pts’ basic characters, especially biomarkers, KELIM scores, etc. were recorded. Survival analyses were conducted using the Kaplan-Meier method and log-rank test, and 95% CI were calculated. The primary endpoint was PFS, and secondary endpoints included time to treatment discontinuation (TTD), time to first subsequent therapy (TFST) and safety. The exploratory endpoint was to establish a clinical prediction model of Niraparib benefits. Results: 199 pts’ data were analyzed. The median(m) follow-up at the time of the data cutoff was 14.93 months (mos) (12.17, 39.47). Baseline characteristics were shown in Table. MPFS was not reached (NR) (29.80 to not be estimated, NE), with maturity 29.64%, and PFS rate at 6, 12, 18, 24mos was 89.4%, 79.5%, 68.3%, 64.5% respectively, showing the efficacy of Niraparib. MPFS (95% CI) in subgroups were as follows: BRCAwt 23.83mos (23.83 to NE); HRD negative 15.63mos (12.6 to NE); KELIM＜1 NR (15.33 to NE); BRCA1/2m, HRD positive and KEILM≥1 subgroups were all NR yet, due to the no longer enough follow-up time and low data maturity. Multivariate analysis found that pts with <65 years, BRCA1/2m, HRD positive, KELIM＞1, and R0 after primary cytoreductive surgery were likely to have longer PFS. The rate of grade ≥3 thrombocytopenia was 19.1%. Treatment discontinuation occurred in 11 (5.5%) pts due to TEAEs. The clinical prediction model for probability of progression was established from 149 pts (training dataset): Score = 0.612 Age ＞65 + 0.3889 BMI ≤23.90 + 0.097 FIGO IV + 0.191Chronic N +1.398 Surgery result R1/R2 +2.552 BRCA wt . The probability of disease progression received Niraparib in 6, 12 and 18m can be obtained by mapping the score to the nomogram. Conclusions: The efficacy and safety of Niraparib in this study are consistent with the results in PRIME. The clinical predictive model established in this database needs more data to be matured and verified. Some baseline characteristics. Characteristics Number % Age (years), medium (range) 57.00 (51.00, 63.50) BMI, medium (range) 23.05 (21.09, 25.12) BRCA mutational status BRCAm BRCAwt Unknown 40 131 28 20.1 65.8 14.1 HRD status Positive Negative Unknown 66 52 81 33.2 26.1 40.7 KELIM score ＞1 ≤1 Unknown 55 23 121 27.6 11.6 60.8