Real world clinical data analysis of fuzuloparib for the treatment of ovarian epithelial cancer patients
10.3760/cma.j.cn112141-20241119-00614
- VernacularTitle:氟唑帕利治疗卵巢上皮性癌的真实世界临床数据分析
- Author:
Danhui WENG
1
;
Jie JIANG
;
Yingjie YANG
;
Mingqian LU
;
Jiaying BAI
;
Ming LIU
;
Xiaoling LI
;
Jun TIAN
;
Yutao GUAN
;
Quan LI
;
Liang CHEN
;
Qiubo LYU
;
Lixia MA
;
Yali WANG
;
Huicheng XU
;
Hailong GUO
;
Li SUN
;
Ding MA
;
Qinglei GAO
Author Information
1. 华中科技大学同济医学院附属同济医院妇瘤科，武汉 430030
- Publication Type:Journal Article
- Keywords:
Real world;
Carcinoma, ovarian epithelial;
Poly (ADP-ribose) polymerase inhibitors;
Treatment outcome;
Data analysis
- From:
Chinese Journal of Obstetrics and Gynecology
2025;60(8):590-599
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the safety and effectiveness of fuzuloparib for the treatment of ovarian epithelial cancer patients in the real world setting.Methods:A retrospective analysis was conducted on the baseline data of 4 620 ovarian cancer patients who had received fuzuloparib monotherapy or combination therapy. Another 224 ovarian cancer patients who were willing to receive fuzuloparib monotherapy or combination therapy were prospectively enrolled, and their baseline characteristics, drug effectiveness, and safety data were analyzed.Results:(1) Among the 4 620 patients in the retrospective cohort, the median age of patients was 60 years; tumor types: 89.8% (4 149/4 620) had ovarian cancer. Among patients with clearly documented information, the vast majority had a histological type of serous carcinoma (82.9%, 3 770/4 546) and International Federation of Gynecology and Obstetrics (FIGO) staging of Ⅲ-Ⅳ (90.9%, 1 537/1 691). (2) Among the 224 patients in the prospective cohort, the median age of patients was 57 years; tumor types: 83.9% (188/224) had ovarian cancer. Among patients with clearly documented records, the predominant pathologic type was serous carcinoma (91.9%, 193/210), and FIGO stage was Ⅲ-Ⅳ in 79.9% (139/174). (3) Among the 224 prospective patients: 84 patients received first-line fluzoparib maintenance therapy, 92 patients received fluzoparib maintenance therapy after platinum-sensitive recurrence, 23 patients received direct fluzoparib treatment after platinum-sensitive recurrence, 19 patients received direct fluzoparib treatment after platinum-resistant recurrence. The median follow-up durations were 8.5, 8.7, 7.9, and 6.7 months, respectively. The median durations of fluzoparib treatment were 6.7, 4.8, 3.1, and 1.9 months, respectively. The median progression-free survival (PFS) times were not reached during follow-up, 12.6 months, not reached during follow-up, and 4.8 months, respectively. The 1-year PFS rates were 84.1%, 55.0%, 69.8%, and 45.5%, respectively. The remaining 6 patients received other fluzoparib regimens. (4) Among the 224 patients in the prospective dataset, 205 had safety data recorded. Of these, 127 patients (62.0%, 127/205) experienced treatment-related adverse events, with common events including anemia (24.4%, 50/205), thrombocytopenia (21.0%, 43/205), and leukopenia (19.5%, 40/205). Among the 205 patients, 43 (21.0%, 43/205) experienced grade 3 or higher treatment-related adverse events, with common events including anemia (8.3%, 17/205) and thrombocytopenia (8.3%, 17/205).Conclusions:The effectiveness of fuzuloparib in clinical application is generally consistent with other drugs in the same class, with good safety. This study provids new clinical evidence for the treatment of ovarian cancer with fuzuloparib.
