Oncological outcome and immune-checkpoint-blockade-induced toxicities in patients with cervical cancer - a Norwegian real-world cohort.

Background and purpose: The introduction of immune checkpoint inhibitors (ICIs) into the treatment of patients with metastatic or recurrent cervical cancer has been shown to significantly prolong survival. In this study, we examined the clinical outcomes and tolerability of treatment with ICIs in patients with metastatic or recurrent cervical cancer in a real-world setting in Norway. Patient/material and methods: This retrospective cohort study included patients treated with an ICI in combination with chemotherapy or as single agent at Oslo University Hospital between 2016 and 2024. The primary oncological endpoint was progression-free survival (PFS). Secondary endpoints include overall survival (OS) as well as tolerability.

Results: We included 57 patients with a median age of 53 years and a median follow-up of 15.2 months. Thirty-five patients were treated with an ICI in combination with chemotherapy (cohort 1), and or an ICI alone (n = 22) (cohort 2). Forty-six patients (81%) were treated for recurrent disease. In cohort 1, the median PFS was 12.4 months (95% CI: 9.0-15.7), and the median OS was 27.5 months (95% CI: 18.0-37.1). In cohort 2, the median PFS was 3.7 months (95% CI: 2.4-5.0), and the median OS was 9.3 months (95% CI: 4.3-14.4). Nine patients (16%) discontinued treatment due to toxicity.

Interpretation: Our real-world data on the use of ICIs alone or in combination showed antitumour efficacy comparable to that reported in clinical studies in patients with advanced or recurrent cervical cancer. Our discontinuation rate highlights that toxicity management and mitigation are paramount when novel drugs are introduced in clinical algorithms.