Li Chen, Liu Shikai, He Yonglan, Yao Hairong, Yuan Zhilin, Yang Jiaxin, Cao Dongyan, Cheng Ninghai, Yang Junjun, Peng Peng, Xiang Yang
National Clinical Research Center for Obstetric & Gynecologic Diseases, Beijing, China.
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
J Gynecol Oncol. 2025 May;36(3):e44. doi: 10.3802/jgo.2025.36.e44. Epub 2024 Oct 25.
To evaluate the efficacy and safety of adding toripalimab to bevacizumab and platinum-based chemotherapy as first-line treatment for refractory recurrent or metastatic (R/M) cervical cancer (CC).
Patients were administered toripalimab (240 mg) + bevacizumab (7.5 mg/kg) combined with platinum-based chemotherapy once every three weeks for six cycles, followed by the maintenance therapy involving toripalimab + bevacizumab once every 3 weeks for 12 months or when disease progression or intolerable toxicity occurred. The primary endpoint was the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. The secondary endpoints were safety profiles, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
Twenty-four patients were enrolled in this study and in the final analysis. The median follow-up duration was 18.6 (range, 3.3-28.5) months. The ORR was 83.3% (95% confidence interval [CI]=62.6-95.3) and the DCR was 95.8% (95% CI=78.9-99.9); 9 (37.5%) patients achieved complete response, 11 (45.8%) achieved partial response, and 3 (12.5%) had stable disease. The median PFS was 22.6 (95% CI=10.4-34.7) months and the median OS was not reached. The most common grade 3 treatment-related adverse events (AEs) were neutropenia (41.7%) and leukopenia (16.7%). The most common immune-related AEs (irAEs) were thyroid dysfunction (37.5%) and increased adrenocorticotropic hormone (37.5%) and serum cortisol levels (33.3%). No grade ≥3 irAEs were observed.
Toripalimab combined with bevacizumab and platinum-based chemotherapy show promising clinical efficacy and favorable safety profile, providing an alternative first-line treatment option for patients with R/M CC.
ClinicalTrials.gov Identifier: NCT04973904.
评估将托瑞帕利单抗添加到贝伐珠单抗和铂类化疗中作为难治性复发或转移性（R/M）宫颈癌（CC）一线治疗的疗效和安全性。
患者接受托瑞帕利单抗（240 mg）+贝伐珠单抗（7.5 mg/kg）联合铂类化疗，每三周一次，共六个周期，随后进行维持治疗，即每三周一次托瑞帕利单抗+贝伐珠单抗，持续12个月或直至疾病进展或出现无法耐受的毒性。主要终点是根据实体瘤疗效评价标准1.1版的客观缓解率（ORR）。次要终点是安全性、疾病控制率（DCR）、无进展生存期（PFS）和总生存期（OS）。
本研究共纳入24例患者并进行最终分析。中位随访时间为18.6（范围3.3 - 28.5）个月。ORR为83.3%（95%置信区间[CI]=62.6 - 95.3），DCR为95.8%（95% CI=78.9 - 99.9）；9例（37.5%）患者达到完全缓解，11例（45.8%）达到部分缓解，3例（12.5%）病情稳定。中位PFS为22.6（95% CI=10.4 - 34.7）个月，中位OS未达到。最常见的3级治疗相关不良事件（AE）是中性粒细胞减少（41.7%）和白细胞减少（16.7%）。最常见的免疫相关AE（irAE）是甲状腺功能障碍（37.5%）、促肾上腺皮质激素升高（37.5%）和血清皮质醇水平升高（33.3%）。未观察到≥3级irAE。
托瑞帕利单抗联合贝伐珠单抗和铂类化疗显示出有前景的临床疗效和良好的安全性，为难治性复发或转移性宫颈癌患者提供了一种一线治疗选择。
ClinicalTrials.gov标识符：NCT04973904。
