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已发表论文
尼拉帕利作为新诊断晚期卵巢癌患者维持治疗的真实世界经验：一项单中心回顾性研究
Authors Liu W, Zhang L, Wu H, Chen Y, Ma Y, Bao L, Fu X, Wang K
Received 20 May 2025
Accepted for publication 15 September 2025
Published 29 October 2025 Volume 2025:18 Pages 1201—1208
DOI https://doi.org/10.2147/OTT.S528382
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Prof. Dr. Geoffrey Pietersz
Wenxin Liu,1,2 Li Zhang,1,2 Huijuan Wu,1,2 Ying Chen,1,2 Yaomei Ma,1,2 Lewen Bao,1,2 Xin Fu,1,2 Ke Wang1,2
1Department of Gynecological Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People’s Republic of China; 2National Clinical Research Center for Cancer, State Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin, People’s Republic of China
Correspondence: Ke Wang, Department of Gynecological Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People’s Republic of China, Email Kewang2005@outlook.com
Objective: This study aimed to evaluate the efficacy and safety of niraparib as a maintenance treatment for newly diagnosed advanced ovarian cancer in a real-world setting.
Methods: This retrospective observational study included patients with histologically confirmed epithelial ovarian cancer, primary peritoneal or fallopian tube cancer who received niraparib as first-line maintenance therapy at Tianjin Cancer Hospital between January 2021 and January 2023. Clinicopathological characteristics and treatment outcomes were extracted from medical records. The efficacy of niraparib was evaluated by progression-free survival (PFS), and safety was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Results: A total of 102 patients were enrolled in this study. After a median follow-up of 21.4 months (IQR 20.4– 22.5 months), the median PFS was 25.7 months in the overall population, not reached in the BRCA mutation group, and 23.0 months in the wild-type group. A total of fifty patients with a known status of homologous recombination deficiency (HRD) were observed. The median PFS was not reached and 23.0 months in the homologous recombination deficiency and proficient groups, respectively. In the BRCA wild-type group, patients who received more than six cycles of platinum-based chemotherapy had a better prognosis. Furthermore, 20.6% of patients experienced grade 3 or higher treatment-emergent adverse events, while 39.2% experienced treatment interruption, 37.3% underwent dose reduction, and 6.9% discontinued treatment. No new safety signals were observed.
Conclusion: In the real-world setting, the use of niraparib as a maintenance treatment for newly diagnosed advanced ovarian cancer has been shown to be effective and well tolerated, which is consistent with the results of previous randomized Phase III trials.
Keywords: ovarian cancer, niraparib, real-word, maintenance
1Department of Gynecological Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People’s Republic of China; 2National Clinical Research Center for Cancer, State Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin, People’s Republic of China
Correspondence: Ke Wang, Department of Gynecological Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People’s Republic of China, Email Kewang2005@outlook.com
Objective: This study aimed to evaluate the efficacy and safety of niraparib as a maintenance treatment for newly diagnosed advanced ovarian cancer in a real-world setting.
Methods: This retrospective observational study included patients with histologically confirmed epithelial ovarian cancer, primary peritoneal or fallopian tube cancer who received niraparib as first-line maintenance therapy at Tianjin Cancer Hospital between January 2021 and January 2023. Clinicopathological characteristics and treatment outcomes were extracted from medical records. The efficacy of niraparib was evaluated by progression-free survival (PFS), and safety was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Results: A total of 102 patients were enrolled in this study. After a median follow-up of 21.4 months (IQR 20.4– 22.5 months), the median PFS was 25.7 months in the overall population, not reached in the BRCA mutation group, and 23.0 months in the wild-type group. A total of fifty patients with a known status of homologous recombination deficiency (HRD) were observed. The median PFS was not reached and 23.0 months in the homologous recombination deficiency and proficient groups, respectively. In the BRCA wild-type group, patients who received more than six cycles of platinum-based chemotherapy had a better prognosis. Furthermore, 20.6% of patients experienced grade 3 or higher treatment-emergent adverse events, while 39.2% experienced treatment interruption, 37.3% underwent dose reduction, and 6.9% discontinued treatment. No new safety signals were observed.
Conclusion: In the real-world setting, the use of niraparib as a maintenance treatment for newly diagnosed advanced ovarian cancer has been shown to be effective and well tolerated, which is consistent with the results of previous randomized Phase III trials.
Keywords: ovarian cancer, niraparib, real-word, maintenance