Cheng Xianzhong, Liu Ping, Zhao Qian, Ye Luxin, Wang Xuening, Chen Jiahui, Chen Yourong, Xu Xia, Guo Wenwen, Ni Jing, Chen Xiaoxiang
Department of Gynecologic Oncology, The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Department of Gynecologic Oncology, The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China; Nanjing Gaochun People's Hospital, Nanjing, China.
Eur J Obstet Gynecol Reprod Biol. 2025 Nov;314:114707. doi: 10.1016/j.ejogrb.2025.114707. Epub 2025 Sep 7.
The first real-world experience of niraparib plus anlotinib after Poly(ADP-ribose) polymerase inhibitors (PARPi) resistance from China were investigated in patients with ovarian cancer.
Patients treated with niraparib plus anlotinib after PARPi resistance in The Affiliated Cancer Hospital of Nanjing Medical University between December 2019 and February 2023 were enrolled. Eligible patients had histologically confirmed high-grade serous ovarian cancer. Objective response rate (ORR) and disease response rate (DCR) were evaluated by response evaluation criteria in solid tumours, version 1.1 (RECIST 1.1). Progression-free survival (PFS) and serum tumor marker fluctuations of Cancer Antigen 125 (CA125) and Human Epididymis Protein 4 (HE4) were also evaluated. Adverse events (AEs) were assessed by Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Twenty-three patients treated with niraparib plus anlotinib had treated a median of two lines of chemotherapy. Most (73.9 %) of enrolled participants were BRCA-wildtype. The ORR and DCR of evaluable patients were 8.3 % and 83.3 %, respectively. The median PFS were 7.230 months for all patients. The median PFS of patients with different platinum status (8.465 months vs. 6.700 months, p = 0.343, initial dose of anlotinib (6.700 months vs. 7.930 months, p = 0.739) and prior use of bevacizumab or not (7.230 months vs. 7.030 months, p = 0.639) were similar. The most common grade 3-4 AEs were hand-foot syndrome and hypertension. No drug related death was reported.
Niraparib combined with anlotinib had promising antitumor activity and manageable AEs in the treatment of ovarian cancer after PARPi resistance.
在中国，对卵巢癌患者在聚（ADP - 核糖）聚合酶抑制剂（PARPi）耐药后使用尼拉帕利联合安罗替尼的首次真实世界经验进行了研究。
纳入2019年12月至2023年2月期间在南京医科大学附属肿瘤医院接受PARPi耐药后使用尼拉帕利联合安罗替尼治疗的患者。符合条件的患者经组织学确诊为高级别浆液性卵巢癌。采用实体瘤疗效评价标准1.1版（RECIST 1.1）评估客观缓解率（ORR）和疾病缓解率（DCR）。还评估了无进展生存期（PFS）以及癌抗原125（CA125）和人附睾蛋白4（HE4）的血清肿瘤标志物波动情况。通过不良事件通用术语标准（CTCAE 5.0）评估不良事件（AE）。
23例接受尼拉帕利联合安罗替尼治疗的患者接受的化疗中位数为两线。大多数（73.9%）入组参与者为BRCA野生型。可评估患者的ORR和DCR分别为8.3%和83.3%。所有患者的中位PFS为7.230个月。不同铂类状态患者的中位PFS（8.465个月对6.700个月，p = 0.343）、安罗替尼初始剂量（6.700个月对7.930个月，p = 0.739）以及既往是否使用贝伐单抗（7.230个月对7.030个月，p = 0.639）相似。最常见的3 - 4级AE为手足综合征和高血压。未报告与药物相关的死亡。
尼拉帕利联合安罗替尼在PARPi耐药后的卵巢癌治疗中具有有前景的抗肿瘤活性且不良事件可控。
