Fuzuloparib with or without apatinib as maintenance therapy in newly diagnosed, advanced ovarian cancer (FZOCUS‐1): A multicenter, randomized, double‐blind, placebo‐controlled phase 3 trial

作者：Lingying Wu, Jing Wang, Qingshui Li, Danbo Wang, Cuiying Zhang, Junying Tang, Guonan Zhang, Min Hao, Desheng Yao, Qinglei Gao, Youzhong Zhang, Ruifang An, Rutie Yin, Li Wang, Bairong Xia, Qi Zhou, Hongying Yang, Jianqing Zhu, Kui Jiang, Zhengzheng Chen, Qiang Wu, Wei Duan, Yi Huang, Hui Zhang, Shuqing Wei, Guiling Li, Yuanguang Meng, Ke Wang, Xinfeng Yang, Xianghua Huang, Lingya Pan, Jinjin Yu, Ge Lou, Yu Zhang, Huaijun Zhou, Xiaoqing Guo, Hong Yang, Xiaodong Cheng, Xiumin Li, Wuliang Wang, Hongqin Zhao, Yunxia Li, Yingjie Yang, Lin An, Wenjun Cheng, Lihong Chen, Xiaoying Xie, Wen Di, Yuanjing Hu, Mo Chen, Hongwu Wen, Liping Cai, Xiaohua Wu, Zhongqiu Lin, Quanren Wang, Xinfeng Yang, Ning Li · 发表于：CA A Cancer Journal for Clinicians · 年份：2025 · DOI：10.3322/caac.70042 · 被引用次数：3 · 研究领域：PARP inhibition in cancer therapy、Ovarian cancer diagnosis and treatment、Cancer Mechanisms and Therapy

Although poly(adenosine diphosphate-ribose) polymerase inhibitors (PARPis) and bevacizumab were approved as first-line maintenance for advanced ovarian cancer (OC), evidence comparing this combination with PARPi monotherapy, especially in BRCA-mutated/homologous recombination-deficient (HRD) patients, is lacking. This study compared combined fuzuloparib (a PARPi) plus apatinib (a vascular endothelial growth factor receptor-2 inhibitor) with either fuzuloparib or placebo as first-line maintenance in patients with advanced OC. Patients who had newly diagnosed, advanced OC and responded to first-line, platinum-based chemotherapy were randomized 2:2:1 to receive combined fuzuloparib (100 mg twice daily) plus apatinib (375 mg daily), fuzuloparib (150 mg twice daily) plus placebo, or double-placebo treatment. The primary end point was blinded independent review committee (BIRC)-assessed progression-free survival (PFS). Six hundred seventy-four patients were randomized to receive fuzuloparib plus apatinib (n = 269), fuzuloparib (n = 269), or placebo (n = 136). At the final analysis (November 1, 2024; 385 BIRC-assessed PFS events; median follow-up, 40 months), the median BIRC-assessed PFS was 26.9 months with the combination versus placebo (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.44-0.75; one-sided p < .0001) and 29.9 months with fuzuloparib monotherapy versus placebo (HR, 0.58; 95% CI, 0.44-0.75; one-sided p < .0001) compared with 11.1 months with placebo. A PFS ben...