Chen J, Shi J M, Cao Y J, Li C, Li J Y, Yuan Z Y
Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin300060, China.
Zhonghua Yi Xue Za Zhi. 2024 Dec 24;104(48):4402-4408. doi: 10.3760/cma.j.cn112137-20240725-01717.
To explore the efficacy and safety of toripalimab combined with platinum-based chemoradiotherapy in the treatment of locally advanced cervical cancer. 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 24 2019 to August 31 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. 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%: 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 (=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, =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, =0.167). 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.
探讨托瑞帕利单抗联合铂类同步放化疗治疗局部晚期宫颈癌的疗效及安全性。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托瑞帕利单抗联合铂类同步放化疗的82例局部晚期宫颈癌患者。同步放化疗后，患者接受托瑞帕利单抗联合紫杉醇和铂类药物的六个周期治疗。研究的主要终点为客观缓解率（ORR），次要终点包括疾病控制率（DCR）、安全性、无进展生存期和总生存期。采用Kaplan-Meier曲线描述不同程序性死亡配体1（PD-L1）表达水平和基因突变负荷患者的无进展生存期（PFS）和总生存期（OS）的累积发生率，并采用对数秩检验比较组间差异。患者的中位年龄为53.6（45.5，58.7）岁，76例（92.7%）为鳞状细胞癌。82例患者的总体ORR和DCR均为87.8%（72例，95%：78.7%-94.0%）。82例患者中，64例（78.0%）达到完全缓解，8例（9.8%）部分缓解，8例（9.8%）疾病进展，2例（2.4%）不可评估。治疗期间，37例患者（45.1%）发生治疗相关不良事件，其中17例患者（20.7%）发生3级或更高等级的不良反应。最常见的3级或更高等级治疗相关不良反应为放射性肠炎（=5，6.1%）。中位随访时间为20.6（14.0，27.9）个月。未达到中位无进展生存期（mPFS）和中位总生存期（mOS）。与PD-L1联合阳性评分（CPS）<10的患者相比，CPS≥10的患者2年PFS率更高（92.4%对81.2%，χ²=0.68，=0.409），与高肿瘤突变负荷（TMB-H）的患者相比，低肿瘤突变负荷（TMB-L）的患者2年PFS率更高（95.2%对83.3%，χ²=1.91，=0.167）。局部晚期宫颈癌患者接受托瑞帕利单抗联合铂类同步放化疗及巩固化疗时可获得良好的客观缓解率。
