再発・転移性子宮頸がんにおけるシンチルマブのリアルワールド有効性評価

Programmed death 1 (PD-1) monoclonal antibodies have been reported as a first-line therapeutic option for recurrent cervical cancer, especially for programmed death ligand 1 (PD-L1)-positive tumors. However, real-world data on the use of PD-1 monoclonal antibodies in patients with an undefined PD-L1 status is scarce. This study analyzed the efficacy and safety of sintilimab in patients with recurrent or metastatic cervical cancer.

Data of patients who received sintilimab for the first time in the First Affiliated Hospital of the Army Medical University from November 2019 to July 2022 were collected. The efficacy and safety of sintilimab were evaluated according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, respectively. The Kaplan-Meier curve and log-rank test were used to analyze patient survival.

Twenty-seven (27) patients were included in the study. The median follow-up was 17 (range, 6-40) months. The objective response rate (ORR) and disease control rate (DCR) were 69.6% and 87.0%, respectively, in efficacy-evaluable patients. The ORR of the combination therapy was significantly higher than that of the monotherapy (82.3% vs. 33.3%, P = 0.045). The ORR was 91.7% for patients who initiated treatment within two months and 37.5% for those who started treatment after two months (P = 0.018). In the intention-to-treat population, 55.5% of the patients experienced adverse events, and 14.8% of the patients had grade 3 or higher treatment-related adverse events.

Sintilimab appeared to demonstrate satisfactory efficacy and safety in the study. The combination therapy showed a higher ORR compared to monotherapy. Furthermore, early initiation of sintilimab as first-line therapy within two months following recurrence is more effective compared to delayed initiation beyond this period in patients with recurrent disease.