AI Article Synopsis
- Cemiplimab, an antibody targeting the PD-1 receptor, is being evaluated in a real-world study in Italy for patients with advanced cervical cancer who have undergone platinum-based chemotherapy, following promising initial trial results.
- The study involved 135 patients, assessing primary outcomes like progression-free survival (PFS) and overall survival (OS), along with safety and response rates to treatment.
- Results showed a median PFS of 4 months and median OS of 12 months, with anemia and fatigue being the most common side effects, highlighting the treatment's feasibility in clinical practice.
Article Abstract
Background: cemiplimab is an immunoglobulin G4 monoclonal antibody targeting the programmed cell death-1 receptor. A nominal use program is available in Italy in advanced cervical cancer (CC) patients treated with platinum based chemotherapy based on the results of EMPOWER-Cervical 1/GOG-3016/ENGOTcx9 trial. This real-world, retrospective cohort, multicenter study aimed at describing clinical outcomes of patients with advanced CC treated with cemiplimab in Italy.
Methods: The primary objective of the study was to assess the feasibility and the replicability of the initial results in a real world setting of cemiplimab nominal use. The primary endpoint of our analysis was progression free survival (PFS). Secondary endpoints included overall response rate (ORR), overall survival (OS) and safety data.
Results: From March 2022 to December 2023, 135 patients were treated in 12 Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) Centers. Forty-two percent of patients had one or more comorbidities, hypertension being the most common (23.4%). Median PFS was 4.0 months (range 3.0-6.0) and median OS was 12.0 months (12.0- NR) with no differences according to PD-L1 status. Complete response (CR) or no evidence of disease (NED) were observed in 8.6%; partial response (PR) in 21.1%, stable disease (SD) in 14.8% and progression was recorded in 44.5% of patients. Most common drug related adverse events (AEs) were anemia (39.1%) and fatigue (27.8%). Immune related AEs occurred in 18.0%.
Conclusions: This study confirms the feasibility and the replicability of the cemiplimab nominal use in advanced CC, in a real-world practice in Italy.
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| http://dx.doi.org/10.1016/j.ejca.2024.114039 | DOI Listing |
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