Fountzilas Elena, Hiep Vo Henry, Mueller Peter, Kurzrock Razelle, Tsimberidou Apostolia-Maria
Department of Medical Oncology, St Luke's Clinic, Panorama 552 36, Thessaloniki, Greece.
European University Cyprus, 6 Diogenous Str., Egkomi, 2404, Nicosia, Cyprus.
Data Brief. 2023 Oct 16;51:109698. doi: 10.1016/j.dib.2023.109698. eCollection 2023 Dec.
We performed a literature search in PubMed to identify phase I/II clinical trials with immunotherapy drugs approved by the Food and Drug Administration (labeled, off-label, and/or combined with investigational immune checkpoint inhibitors or other treatment modalities) from 2018 to 2020. We used the following key words: clinical trials, phase 1, Phase 2; and the following filters: cancer, humans; and selected the checkpoint inhibitors that had been approved by the FDA by March 2021, i.e., "pembrolizumab", "nivolumab", "atezolizumab", "durvalumab", "cemiplimab", "avelumab", and "ipilimumab. Clinical trials with their checkpoint inhibitors as in their labeled indications, off-label use or their combinations with investigational immune checkpoint inhibitors or other treatment modalities were included. Studies describing supportive care or locoregional treatments; cellular, viral, or vaccine therapy; studies in the adjuvant or neoadjuvant setting; and pediatric studies were excluded. Overall, 173 articles reporting on relevant studies were identified. Using these articles, we compiled a data file of study-specific covariates for each study. We recorded the immunotherapeutic agent, tumor type and biomarker, and clinical outcomes (objective response rate and median values [point estimate] and confidence intervals for progression-free survival and overall survival. Using these data, we carried out meta-analyses for the three outcomes and meta-regression on study-specific covariates. The same data could be used for any alternative implementation of meta-analysis and meta-regression, using more structured inference models reflecting different levels of dependence based on the available study-specific covariates.
我们在PubMed上进行了文献检索，以确定2018年至2020年期间使用美国食品药品监督管理局（FDA）批准的免疫治疗药物（包括标签注明的、超适应证使用的和/或与研究性免疫检查点抑制剂或其他治疗方式联合使用的）的I/II期临床试验。我们使用了以下关键词：临床试验、1期、2期；以及以下筛选条件：癌症、人类；并选择了截至2021年3月已被FDA批准的检查点抑制剂，即“帕博利珠单抗”“纳武利尤单抗”“阿特珠单抗”“度伐利尤单抗”“西米普利单抗”“阿维鲁单抗”和“伊匹木单抗”。纳入了将这些检查点抑制剂用于其标签注明适应证、超适应证使用或与研究性免疫检查点抑制剂或其他治疗方式联合使用的临床试验。排除了描述支持治疗或局部区域治疗的研究；细胞、病毒或疫苗治疗的研究；辅助或新辅助治疗环境下的研究；以及儿科研究。总体而言，共确定了173篇报告相关研究的文章。利用这些文章，我们为每项研究编制了特定研究协变量的数据文件。我们记录了免疫治疗药物、肿瘤类型和生物标志物，以及临床结果（客观缓解率、无进展生存期和总生存期的中位值[点估计值]及置信区间）。利用这些数据，我们对这三项结果进行了荟萃分析，并对特定研究协变量进行了荟萃回归。基于可用的特定研究协变量，使用反映不同依赖程度的更结构化推断模型，相同的数据可用于荟萃分析和荟萃回归的任何替代实施。
