1. Overall survival is longer in patients treated with cemiplimab as compared to chemotherapy.
2. Fewer adverse effects are associated with the use of cemiplimab compared to chemotherapy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Recurrent cervical cancer is associated with poor prognostic outcomes. The programmed cell death (PD-1) blocking antibody, cemiplimab, has been shown to have activity in cervical cancer. This study aimed to compare cemiplimab to chemotherapy on outcomes of overall survival (OS), progression-free survival (PFS), and safety. Median OS for the overall study population in the cemiplimab group (12.0 months) was longer than in the chemotherapy group (8.5 months). Median PFS in the overall study population was 2.8 months in the cemiplimab group, as compared to 2.9 months in the chemotherapy group. Adverse events (AEs) were recorded in 88.3% of patients in the cemiplimab group and 91.4% of the chemotherapy group. Serious events were higher in the chemotherapy group (53.4%) versus the cemiplimab group (45.0%). Immune-related adverse events were more prevalent in the cemiplimab group (15.7%) than in the chemotherapy group (0.7%). The most common serious AEs were anemia, urinary tract infection (UTI), and neutropenia. Limitations to this study include a smaller sample size. Overall, survival benefits are associated with cemiplimab in the treatment of recurrent cervical cancer.
Click to read the study in the New England Journal of Medicine
Relevant Reading: Evidence-Based Treatment Paradigms for Management of Invasive Cervical Carcinoma
In-Depth [randomized controlled trial]: This phase 3 trial enrolled and randomly assigned 608 adult women in a 1:1 fashion to receive either cemiplimab or chemotherapy (304 for each group). The primary study outcome was overall survival (OS). Secondary outcomes included progression-free survival (PFS) and safety. Median OS in the overall study population was 12.0 months in the cemiplimab group (95% confidence interval (CI), 10.3 to 13.5 months), as compared to 8.5 months in the chemotherapy group (95% CI, 7.5 to 9.6 months) (hazard ratio (HR) 0.69; 95% CI, 0.56 to 0.84). Median PFS in the overall study population was 2.8 months in the cemiplimab group (95% CI, 2.6 to 3.9 months) and 2.9 months in the chemotherapy group (95% CI, 2.7 to 3.4 months) (HR, 0.75; 95% CI, 0.63 to 0.89). Adverse events were recorded in 88.3% of patients in the cemiplimab group and 91.4% in the chemotherapy group. Serious events were higher in the chemotherapy group (53.4%) versus the cemiplimab group (45.0%). Anemia occurred in 12.0% of patients on cemiplimab, versus 26.9% of those on chemotherapy; UTI occurred in 5.0% and 2.8% respectively, and neutropenia occurred in 1.0% and 9.0% respectively. Immune-related adverse events occurred more frequently in the cemiplimab group (15.7%) than in the chemotherapy group (0.7%).
Image: PD
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