Introduction:This cross-sectional study was aimed at estimating the number of Italian incident cancer patients in 2020 eligible for, and respondent to, immune checkpoint inhibitors (ICI).Methods:The study is based on publicly available data: the ICI approved until August 2022 by the Italian Medicines Agency (AIFA) with their specific indications and overall observed responses, rther details can be found in the Online Supplementary Materi cancer incidence estimates at 2020 and observed cancer deaths, and published papers with estimates on the frequency of different cancer stage/histology/markers etc. corresponding to AIFA authorizations.Results:In the analyzed period, a total of seven ICI were authorized in Italy for 20 cancer types. The estimated number of ICI-eligible patients in 2020 was 48,400, 14.3% of those tumors (including skin epitheliomas) that may fit AIFA-indications, and 10.5% of all the incident malignant tumors, including skin epitheliomas. The number of patients who may benefit from ICI therapy was 24,052, 49.7% of the ICI-eligible ones, or 5.2% of the overall estimated incident cancers in 2020.Conclusions:In conclusion, although the number of ICI-eligible patients is a relatively small proportion of the yearly burden of cancers, about half of them may respond to ICI-treatment.

中文翻译：

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有多少意大利癌症患者有资格使用意大利药品管理局批准的检查点免疫抑制剂，并且可能对其产生反应？

简介：这项横断面研究旨在估计 2020 年意大利发生癌症的患者中有多少人符合免疫检查点抑制剂 (ICI) 的条件并对其有反应。方法：该研究基于公开数据：ICI 批准截至 8 月意大利药品管理局 (AIFA) 发布了 2022 年的具体适应症和总体观察到的反应，更多详细信息可以在在线补充材料中找到 2020 年癌症发病率估计和观察到的癌症死亡人数，以及发表的论文，其中估计了不同癌症阶段的频率与AIFA授权相对应的/组织学/标志物等。结果：在分析期间，意大利总共有7个ICI获得授权，用于20种癌症类型。预计 2020 年符合 ICI 资格的患者人数为 48,400 人，占可能符合 AIFA 适应症的肿瘤（包括皮肤上皮瘤）的 14.3%，占所有发生的恶性肿瘤（包括皮肤上皮瘤）的 10.5%。可能受益于 ICI 治疗的患者人数为 24,052 人，占 ICI 资格患者的 49.7%，占 2020 年总体估计癌症发病率的 5.2%。结论：总而言之，尽管 ICI 资格患者人数相对较少，但每年癌症负担的一小部分，其中大约一半可能对 ICI 治疗有反应。