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Abstract：
BACKGROUND: Studies evaluating the effectiveness of immune checkpoint inhibitors (ICI) for endometrial cancer (EC) are limited. This study aimed to assess the efficacy of PD-1/PD-L1 inhibitors as monotherapy for EC by conducting a meta-analysis. The predictive significance of MMR status, a biomarker for ICI response, also required further investigation.
METHODS: A systematic literature search was conducted in English databases until September 2023. The analysis included objective response rate (ORR), disease control rate (DCR), adverse events (AEs), and odds ratios (OR), along with their corresponding 95% confidence intervals (CI).
RESULTS: There were twelve trials totaling 685 individuals. PD-1/PD-L1 inhibitor monotherapy resulted in an ORR for 34% (95% CI = 24-44%) of the pooled EC patients. Subgroup analysis revealed a significantly higher ORR in dMMR EC (45%) compared to pMMR EC (8%), with an OR of 6.36 (95% CI = 3.64-11.13). The overall DCR was 42%, with dMMR EC at 51% and pMMR EC at 30% (OR = 2.61, 95% CI = 1.69-4.05). Grade three or higher adverse events (AEs) occurred in 15% of cases (95% CI = 9-24%) of the pooled incidence of AEs, which was 68% (95% CI = 65-72%).
CONCLUSIONS: This meta-analysis provides significant evidence for the effectiveness of PD-1/PD-L1 inhibitors as monotherapy for EC. Notably, dMMR EC patients demonstrated superior treatment efficacy with PD-1/PD-L1 inhibitor immunotherapy. Further research is required to explore subclassifications of EC based on dMMR molecular subtypes, enabling improved treatment strategies and outcomes for EC patients.
METHODS: A systematic literature search was conducted in English databases until September 2023. The analysis included objective response rate (ORR), disease control rate (DCR), adverse events (AEs), and odds ratios (OR), along with their corresponding 95% confidence intervals (CI).
RESULTS: There were twelve trials totaling 685 individuals. PD-1/PD-L1 inhibitor monotherapy resulted in an ORR for 34% (95% CI = 24-44%) of the pooled EC patients. Subgroup analysis revealed a significantly higher ORR in dMMR EC (45%) compared to pMMR EC (8%), with an OR of 6.36 (95% CI = 3.64-11.13). The overall DCR was 42%, with dMMR EC at 51% and pMMR EC at 30% (OR = 2.61, 95% CI = 1.69-4.05). Grade three or higher adverse events (AEs) occurred in 15% of cases (95% CI = 9-24%) of the pooled incidence of AEs, which was 68% (95% CI = 65-72%).
CONCLUSIONS: This meta-analysis provides significant evidence for the effectiveness of PD-1/PD-L1 inhibitors as monotherapy for EC. Notably, dMMR EC patients demonstrated superior treatment efficacy with PD-1/PD-L1 inhibitor immunotherapy. Further research is required to explore subclassifications of EC based on dMMR molecular subtypes, enabling improved treatment strategies and outcomes for EC patients.
摘要：
背景：评估免疫检查点抑制剂（ICI）对子宫内膜癌（EC）的有效性的研究有限。这项研究旨在通过进行荟萃分析来评估PD-1/PD-L1抑制剂作为EC单一疗法的疗效。MMR状态的预测意义，ICI反应的生物标志物，还需要进一步调查。
方法：在英文数据库中进行系统的文献检索，直至2023年9月。分析包括客观反应率(ORR)，疾病控制率（DCR），不良事件（AE），和赔率比(OR)，以及相应的95%置信区间(CI)。
结果：共有12项试验，共685人。PD-1/PD-L1抑制剂单一疗法导致34%(95%CI=24-44%)的合并EC患者的ORR。亚组分析显示dMMREC（45％）的ORR明显高于pMMREC（8％），OR为6.36（95%CI=3.64-11.13）。总DCR为42%,dMMREC为51%，pMMREC为30%(OR=2.61，95%CI=1.69-4.05)。3级或以上不良事件（AEs）发生在合并的AEs发生率的15%（95%CI=9-24%）中，这是68%（95%CI=65-72%）。
结论：这项荟萃分析为PD-1/PD-L1抑制剂作为EC单一疗法的有效性提供了重要证据。值得注意的是,dMMREC患者使用PD-1/PD-L1抑制剂免疫疗法表现出优异的治疗效果。需要进一步的研究来探索基于dMMR分子亚型的EC子分类，改善EC患者的治疗策略和结局。
方法：在英文数据库中进行系统的文献检索，直至2023年9月。分析包括客观反应率(ORR)，疾病控制率（DCR），不良事件（AE），和赔率比(OR)，以及相应的95%置信区间(CI)。
结果：共有12项试验，共685人。PD-1/PD-L1抑制剂单一疗法导致34%(95%CI=24-44%)的合并EC患者的ORR。亚组分析显示dMMREC（45％）的ORR明显高于pMMREC（8％），OR为6.36（95%CI=3.64-11.13）。总DCR为42%,dMMREC为51%，pMMREC为30%(OR=2.61，95%CI=1.69-4.05)。3级或以上不良事件（AEs）发生在合并的AEs发生率的15%（95%CI=9-24%）中，这是68%（95%CI=65-72%）。
结论：这项荟萃分析为PD-1/PD-L1抑制剂作为EC单一疗法的有效性提供了重要证据。值得注意的是,dMMREC患者使用PD-1/PD-L1抑制剂免疫疗法表现出优异的治疗效果。需要进一步的研究来探索基于dMMR分子亚型的EC子分类，改善EC患者的治疗策略和结局。
