Advanced сervical cancer treatment with immune checkpoint inhibitors in real clinical practice: evaluation of efficacy and safety. A retrospective study

Background. Recent clinical trials have demonstrated the potential efficacy of immune checkpoint inhibitors as monotherapy or in combination for the treatment of patients with advanced cervical cancer (CC). At the same time, the effectiveness and safety of this treatment approach in domestic clinical practice remain largely unexplored.

Aim. To evaluate the efficacy and safety of immune checkpoint inhibitors in patients with advanced CC in real clinical practice.

Materials and methods. From January 2018 to June 2023, a retrospective analysis of the efficacy and safety of pembrolizumab therapy was performed in 96 patients, all with histologically confirmed CC: squamous cell (n=81), adenocarcinoma (n=12) and adenosquamous cancer (n=3). At the start of immunotherapy, 21.9% of patients had locoregional relapse and 78.1% distant metastases. The proportion of patients with de novo metastatic CC was 12.5%. The vast majority had a satisfactory somatic condition at the start of therapy – ECOG 0-1 (80.2%). The response to therapy was assessed according to the iRECIST criteria. Statistical analysis was performed using StatTech v. 4.8.11. Patient survival function was estimated using the Kaplan–Meier method.

Results. The objective response rate was 29.2% (n=28), disease control was achieved in 52.1% (n=50) of patients. The median time to response was 3.0 months (1.8–16.0 months), the median duration of response was 14.0 months (1.9–53.2 months). Median рrogression-free survival was 7.6 months (95% confidence interval – CI 5.0–11.0), the median overall survival was 24.0 months (95% CI 15.0–32.4). The median overall survival in the local recurrence group was 11.5 months (95% CI 3.4–22.2), in the group with metachronous metastases – 32.4 months (95% CI 21.4–72.2), and in the group with initially metastatic cancer – 7.8 months (95% CI 5.2–28.5).

Conclusion. Monotherapy with pembrolizumab has shown high efficacy and manageable safety in patients with advanced CC. However, these advantages are primarily observed in the group of patients with metachronous distant metastases. The presence of an unresected or unirradiated primary or recurrent tumor contributes to poorer outcomes with immunotherapy.