Efficacy and safety of immune checkpoint inhibitors with chemoradiotherapy/chemotherapy in locally advanced cervical cancer patients: a systematic review and single-arm meta-analysis

免疫检查点抑制剂联合放化疗/化疗治疗局部晚期宫颈癌患者的疗效和安全性:系统评价和单臂荟萃分析

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Abstract

OBJECTIVE: Recent advancements highlight promising outcomes with immune checkpoint inhibitors (ICIs) when combined with concurrent chemoradiotherapy (CCRT) or chemotherapy in the treatment of locally advanced cervical cancer (LACC). This systematic review and meta-analysis aimed to assess the efficacy and safety of ICIs combined with CCRT/chemotherapy in patients with LACC. METHODS: We searched PubMed, Embase, Cochrane and ClinicalTrials.gov for randomized controlled trials (RCTs) and non-RCTs assessing the efficacy and safety of ICIs plus CCRT/chemotherapy in patients with LACC. All analyses were performed in R software (v.4.4.0). RESULTS: Our systematic review and meta-analysis included 3 RCTs and 4 observational studies, corresponding to 1,250 patients. The 1-year progression-free survival (PFS) was 78% (95% confidence interval [CI]=75-80, I²=0%), while the 1-year overall survival (OS) reached 93% (95% CI=89-95, I²=50%). The objective response rates were 88% (95% CI=74-95, I²=74%). We performed a comparative analysis of PFS and OS using data from the 2 RCTs. The results indicated that the ICI plus CCRT group had a significantly lower risk of disease progression or death compared to the CCRT group alone (PFS: hazard ratio [HR]=0.76, 95% CI=0.64-0.91, I²=4%; OS: HR=0.76, 95% CI=0.58-0.98, I²=0%), representing an approximate 25% reduction in risk. The analysis of grade ≥3 adverse events revealed the low incidences, with none exceeding 15%. CONCLUSION: Our findings suggest that ICIs are effective and safe to use with CCRT/chemotherapy in LACC patients. Further RCTs are needed to confirm these findings. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews Identifier: CRD42024576145.

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