Real-world outcomes of immune checkpoint inhibitor monotherapy in later lines of recurrent/metastatic cervical cancer - evidence from a rescue access program in Poland.

Introduction: Immune checkpoint inhibitors (ICIs) are a therapeutic option for recurrent/metastatic cervical cancer (r/mCC) following platinum-based chemotherapy. However, real-world data on their effectiveness and safety remain limited, particularly in Eastern Europe. This study evaluates the real-world outcomes of ICI monotherapy in pretreated patients with r/mCC. Material and methods: This multicentre retrospective study included 39 patients with r/mCC who received ICI monotherapy (cemiplimab or pembrolizumab) after disease progression on platinum-based chemotherapy in 5 reference centres in Poland. The primary endpoints were overall survival (OS), progression-free survival (PFS), objective response rate, and disease control rate (DCR). The secondary endpoint was treatment safety. Kaplan-Meier estimates were used for survival analysis, and Cox proportional hazards models assessed prognostic factors, with p < 0.05 considered statistically significant. Results: After a median follow-up of 8.8 months, the median PFS was 5.7 months (95% confidence interval [CI] 4.9-6.4), and the median OS was 10.9 months (95% CI: 7.3-14.5). The objective response rate was 23% (n = 9), while the DCR was 64% (n = 25). Immune checkpoint inhibitors were generally well tolerated, with thyroid dysfunction, anaemia, and hepatic toxicity being the most common adverse events (AEs). The discontinuation of treatment due to AEs occurred in only 5% of the patients (n = 2). Immune-related adverse events (irAEs), particularly endocrine toxicities, were associated with significantly prolonged PFS (HR 0.2, 95% CI: 0.09-0.6, p = 0.001; HR 0.2, 95% CI: 0.06-0.6, p = 0.004, for the occurrence of irAEs and endocrine toxicities, respectively). Conclusions: Immune checkpoint inhibitor monotherapy demonstrated modest efficacy in pretreated patients with r/mCC, with a manageable safety profile and irAEs of predictive significance for PFS.