PD-1 inhibitor plus concurrent chemoradiotherapy for high-risk locally advanced cervical cancer.

Aim: The prognosis of high-risk, locally advanced cervical cancer (LACC) remains poor following concurrent chemoradiotherapy (CCRT). We investigated whether the effect of CCRT can be enhanced by programmed cell death protein 1 (PD-1) inhibitor. Methods: A retrospective cohort study was conducted to compare the efficacy and safety of CCRT group (n = 82) and PD-1 inhibitor plus CCRT group (n = 70). Results: Compared with the CCRT group, the PD-1 inhibitor plus CCRT group had significantly higher objective response rate, median progression-free survival, leukopenia and fatigue. The addition of PD-1 inhibitor to CCRT showed a favorable trend in overall survival without statistical significance. Conclusion: PD-1 inhibitor plus CCRT presented a significant survival benefit and a manageable safety profile in high-risk LACC. Article highlights The prognosis of high-risk locally advanced cervical cancer (LACC) (FIGO 2014 stage IB2–IIB with positive para-aortic lymph nodes and stage IIIA–IVA) remains poor after concurrent chemoradiotherapy (CCRT). Programmed death ligand-1 (PD-1) inhibitors have shown efficacy in patients with cervical cancer, and whether the effect of CCRT can be enhanced by PD-1 inhibitor is a hot topic in high-risk LACC research. This retrospective cohort study was conducted to compare the efficacy and safety of CCRT alone (n = 82 patients) and PD-1 inhibitor plus CCRT (n = 70 patients). Compared with the CCRT-alone group, the PD-1 inhibitor plus CCRT group had a significantly higher objective response rate and median progression-free survival (PFS) but also higher incidence of leukopenia and fatigue. The addition of PD-1 inhibitor to CCRT showed a favorable trend in overall survival (OS) without statistical significance. Compared with the PD-L1-negative subgroup, PFS (p = 0.002) and OS (p = 0.032) in the PD-L1-positive subgroup were significantly improved. Multivariate analysis showed that total radiotherapy duration >56 days (hazard ratio [HR]: 4.799), FIGO 2009 stage IVA (HR: 6.464), and combined PD-1 inhibitor (HR: 0.324) were independent determinants of disease progression. PD-1 inhibitor plus CCRT presented a significant survival benefit and a manageable safety profile in high-risk LACC. It can be considered as a new alternative treatment for this patient population. The effects of different timing of PD-1 inhibitor combination with radiotherapy and different duration of PD-1 inhibitor maintenance therapy on survival outcomes need to be further explored in future studies. This is an exploratory study that adds to the literature on high-risk LACC and PD-1 inhibitor, prospective studies are needed to determine the value of PD-1 inhibitor plus CCRT for high-risk LACC. [ABSTRACT FROM AUTHOR]