Objective: To explore the efficacy and safety of toripalimab combined with platinum-based chemoradiotherapy in the treatment of locally advanced cervical cancer. Methods: A total of 82 patients diagnosed as locally advanced cervical cancer who received toripalimab combined with platinum-based concurrent chemoradiotherapy at Tianjin Medical University Cancer Institute and Hospital from May 24th 2019 to August 31st 2022 were enrolled prospectively. After undergoing concurrent chemoradiotherapy, the patient received six cycles of treatment with toripalimab in combination with paclitaxel and platinum-based agents. The primary endpoint of the study was the objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), safety, progression-free survival, and overall survival. Kaplan-Meier curves were used to depict the cumulative incidence of progression-free survival (PFS) and overall survival (OS) for patients with different expression levels of programmed death-ligand 1 (PD-L1) and genetic mutation burdens, and log-rank tests were used to compare the difference between groups. Results: The median age of the patients was 53.6 (45.5,58.7) years, and 76 patients (92.7%) had squamous cell carcinoma. The overall ORR and DCR for the 82 patients were both 87.8% (72 patients, 95%CI: 78.7%-94.0%). Among the 82 patients, 64 (78.0%) achieved complete remission, 8 (9.8%) had partial remission, 8 (9.8%) had disease progression, and 2 (2.4%) were not evaluable. During the treatment, 37 patients (45.1%) experienced treatment-related adverse events, of which 17 patients (20.7%) had grade 3 or higher adverse reactions. The most common grade 3 or higher treatment-related adverse reaction was radiation enteritis (n=5, 6.1%). The median follow-up time was 20.6 (14.0, 27.9) months. The median progression-free survival (mPFS) and median overall survival (mOS) were not reached. The 2-year PFS rate was higher in patients with PD-L1 combined positive score (CPS)≥10 compared to those with CPS<10 (92.4% vs 81.2%, χ²=0.68, P=0.409), and higher in patients with low tumor mutation burden (TMB-L) compared to those with high tumor mutation burden (TMB-H) (95.2% vs 83.3%, χ²=1.91, P=0.167). Conclusion: Patients with locally advanced cervical cancer can achieve favorable objective response rates when treated with toripalimab in combination with platinum-based concurrent chemoradiotherapy and consolidative chemotherapy.
目的： 探讨特瑞普利单抗联合含铂方案同步放化疗治疗局部晚期子宫颈癌的临床疗效与安全性。 方法： 前瞻性纳入2019年5月24日至2022年8月31日在天津医科大学肿瘤医院接受特瑞普利单抗联合含铂方案同步放化疗的82例局部晚期子宫颈癌患者。患者在接受同步放化疗后接受6个周期特瑞普利单抗联合紫杉醇及铂类治疗。主要观察终点为客观缓解率（ORR），次要终点为疾病控制率（DCR）、安全性、无进展生存期和总生存期。使用Kaplan-Meier绘制程序性细胞死亡配体1（PD-L1）表达量、基因突变负荷的患者无进展生存和总生存的累积发生率，并采用log-rank检验比较组间差异。 结果： 患者年龄［M（Q1，Q3）］为53.6（45.5，58.7）岁，76例（92.7%）为鳞状细胞癌。全组82例患者的ORR和DCR均为87.8%（72例）；达到完全缓解的患者为64例（78.0%），部分缓解为8例（9.8%），疾病进展8例（9.8%），不可评价为2例（2.4%）。治疗期间有37例（45.1%）患者出现治疗相关不良事件，其中17例（20.7%）≥3级不良反应。最常见的≥3级治疗相关不良反应为放射性肠炎（5例，6.1%）。82例患者随访时间［M（Q1，Q3）］为20.6（14.0，27.9）个月，中位无病生存期及中位总生存期均未达到。PD-L1联合阳性分数（CPS）≥10的患者2年无进展生存率较CPS<10的患者高（92.4%比81.2%，P=0.409），肿瘤突变负荷低（TMB-L）的患者2年无进展生存率较肿瘤突变负荷高（TMB-H）的患者高（95.2%比83.3%，P=0.167）。 结论： 局部晚期子宫颈癌患者接受特瑞普利单抗联合铂类同步放化疗及巩固化疗可获得良好的客观缓解率。.