Wang Xin, Wang Chunsheng, Zong Dan, Zhu Biqing, He Xia
Department of Radiotherapy, The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Front Oncol. 2025 Aug 27;15:1634779. doi: 10.3389/fonc.2025.1634779. eCollection 2025.
The aim of this study was to assess the real-world effectiveness and safety of first-line treatment with cadonilimab plus paclitaxel-platinum ± bevacizumab for persistent, recurrent, or metastatic cervical cancer (p/r/m CC).
In this retrospective real-world study from Jiangsu Cancer Hospital (January 2021-February 2025), patients with p/r/m CC received first-line cadonilimab plus paclitaxel-platinum ± bevacizumab or paclitaxel-platinum ± bevacizumab. Co-primary endpoints were progression-free survival (PFS) and safety; overall survival (OS), objective response rate (ORR), and disease control rate (DCR) were secondary. Kaplan-Meier and log-rank methods were applied, with prognostic factors analyzed using Cox models.
Among 169 eligible patients (50 cadonilimab plus TP; 119 TP), median follow-up was 33.2 months [interquartile range (IQR): 12.2-35.2]. Cadonilimab addition significantly prolonged mPFS [20.2 vs. 12.2 months; hazard ratio (HR): 0.531, = 0.019], with 12- and 24-month PFS rates of 65.83% and 48.62% versus 50.71% and 29.57%, respectively. ORR improved from 40.3% to 54.0%, while DCR remained high in both cohorts (92.0% vs. 90.8%). mOS was not reached in the cadonilimab plus TP group and was 37.5 months with TP alone. Cadonilimab increased low-grade immune-related or gastrointestinal adverse events, with the most common being rash or itching (38.0%), pyrexia (32.0%), constipation (58.0%), and diarrhea (50.0%). However, events in grades 3-5 were infrequent. Subgroup analyses showed a generally consistent PFS benefit with cadonilimab across most predefined patient subsets.
In real-world clinical settings, cadonilimab plus TP ± bevacizumab provides a durable PFS benefit with acceptable safety and supports first-line use for p/r/m CC; additional follow-up is essential to determine its impact on OS.
本研究旨在评估卡度尼利单抗联合紫杉醇-铂类±贝伐珠单抗一线治疗持续性、复发性或转移性宫颈癌（p/r/m CC）的真实世界有效性和安全性。
在这项来自江苏省肿瘤医院的回顾性真实世界研究（2021年1月至2025年2月）中，p/r/m CC患者接受一线卡度尼利单抗联合紫杉醇-铂类±贝伐珠单抗或紫杉醇-铂类±贝伐珠单抗治疗。共同主要终点为无进展生存期（PFS）和安全性；总生存期（OS）、客观缓解率（ORR）和疾病控制率（DCR）为次要终点。应用Kaplan-Meier法和对数秩检验，使用Cox模型分析预后因素。
169例符合条件的患者中（50例卡度尼利单抗联合TP；119例TP），中位随访时间为33.2个月[四分位间距（IQR）：12.2 - 35.2]。加用卡度尼利单抗显著延长了mPFS[20.2个月对12.2个月；风险比（HR）：0.531，P = 0.019]，12个月和24个月的PFS率分别为65.83%和48.62%，而单独TP组分别为50.71%和29.57%。ORR从40.3%提高到54.0%，而两个队列的DCR均保持较高水平（92.0%对90.8%）。卡度尼利单抗联合TP组未达到mOS，单独TP组为37.5个月。卡度尼利单抗增加了低级别免疫相关或胃肠道不良事件，最常见的是皮疹或瘙痒（38.0%）、发热（32.0%）、便秘（58.0%）和腹泻（50.0%）。然而，3 - 5级事件很少见。亚组分析显示，在大多数预定义的患者亚组中，卡度尼利单抗对PFS的获益总体一致。
在真实世界临床环境中，卡度尼利单抗联合TP±贝伐珠单抗可提供持久的PFS获益，安全性可接受，支持用于p/r/m CC的一线治疗；需要进一步随访以确定其对OS的影响。
