[A prospective phase Ⅱ clinical trial of toripalimab combined with platinum-based concurrent chemoradiotherapy and consolidation chemotherapy in patients with locally advanced cervical cancer].

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.