Wen Qiang, Yu Hao, Pan Mei, Chao Hongtu, Gao Yuhua, Niu Shuhuai, Zhao Hongqin, Chen Youguo, Zhu Jianqing
Zhejiang Cancer Hospital, Hangzhou, PR China.
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, PR China.
EClinicalMedicine. 2025 Jun 24;85:103308. doi: 10.1016/j.eclinm.2025.103308. eCollection 2025 Jul.
To investigate the efficacy and safety of first-line treatment with tislelizumab plus low-dose bevacizumab and standard chemotherapy in patients with persistent, recurrent, or metastatic cervical cancer.
This open-label, multicenter, single-arm, phase 2 study (NCT05247619) enrolled adult patients with persistent, recurrent, or metastatic cervical cancer and an Eastern Cooperative Oncology Group performance status score of 0-1. Patients received tislelizumab (200 mg), bevacizumab (7.5 mg/kg), paclitaxel (175 mg/m), and cisplatin (50 mg/m) or carboplatin (AUC = 5) on day 1 of cycle 1 (every 3 weeks) in safety run-in stage. Patients entered dose expansion stage to receive the treatment if no dose-limiting toxicities were reported in ≥2 of the 6 patients. Primary end point was progression-free survival (PFS). Safety, tolerability, objective response rate (ORR), and disease control rate (DCR) as well as duration of response (DOR) for persistent, recurrent, or metastatic cervical cancer were the secondary end points.
Between May 2022 and March 2023, a total of 51 patients were enrolled from 8 centers across China (median age: 54 years), and most had distant metastases at enrollment (54.9%). Median PFS reached 22.6 months (95% CI: 14.6, not reached). The ORR was 91.5% (95% CI: 79.6, 97.6), DCR was 100% (95% CI: 92.5, 100.0) and the 18-month DOR rate was 51.5% (95% CI: 31.0, 68.7). Anemia and decreased platelet count were the most common grade ≥3 treatment-emergent (21.6% and 19.6%, respectively) and treatment-related adverse events (TRAEs, 17.6% each). Grade ≥3 TRAEs of special interest associated with bevacizumab were proteinuria (3.9%), fistula and vaginal bleeding (2.0% each).
Tislelizumab in combination with low-dose bevacizumab and chemotherapy demonstrated promising efficacy with favorable safety profile as first-line treatment for persistent, recurrent, or metastatic cervical cancer.
This work was supported by grants from the Pioneer R&D Program of Zhejiang (2023SDYXS0001, 2022C03031) and by BeiGene (Beijing) Co., Ltd. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
探讨替雷利珠单抗联合低剂量贝伐珠单抗及标准化疗作为一线治疗方案用于持续性、复发性或转移性宫颈癌患者的疗效和安全性。
这项开放标签、多中心、单臂、2期研究（NCT05247619）纳入了持续性、复发性或转移性宫颈癌成年患者，其东部肿瘤协作组体能状态评分为0 - 1分。在安全性导入期，患者于第1周期第1天（每3周一次）接受替雷利珠单抗（200 mg）、贝伐珠单抗（7.5 mg/kg）、紫杉醇（175 mg/m²）和顺铂（50 mg/m²）或卡铂（AUC = 5）治疗。若6例患者中≥2例未报告剂量限制性毒性，则患者进入剂量扩展期接受治疗。主要终点为无进展生存期（PFS）。安全性、耐受性、客观缓解率（ORR）、疾病控制率（DCR）以及持续性、复发性或转移性宫颈癌的缓解持续时间（DOR）为次要终点。
2022年5月至2023年3月期间，中国8个中心共纳入51例患者（中位年龄：54岁），多数患者入组时已有远处转移（54.9%）。中位PFS达到22.6个月（95%CI：14.6，未达到）。ORR为91.5%（95%CI：79.6，97.6），DCR为100%（95%CI：92.5，100.0），18个月DOR率为51.5%（95%CI：31.0，68.7）。贫血和血小板计数降低是最常见的≥3级治疗中出现的不良事件（分别为21.6%和19.6%）以及与治疗相关的不良事件（TRAEs，各为17.6%）。与贝伐珠单抗相关的特别关注的≥3级TRAEs为蛋白尿（3.9%）、瘘管和阴道出血（各为2.0%）。
替雷利珠单抗联合低剂量贝伐珠单抗及化疗作为持续性、复发性或转移性宫颈癌的一线治疗方案显示出有前景的疗效和良好安全特征。
本研究得到浙江省重点研发计划（2023SDYXS0001，2022C03031）及百济神州（北京）生物科技有限公司的资助。资助者在研究设计、数据收集与分析、出版决策或稿件撰写方面均未发挥作用。
