Supplementary figures: Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data

These are peer-reviewed supplementary materials for the article 'Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data' published in the Journal of Comparative Effectiveness Research.Supplemental Figure 1: Overall survival in matched cohorts, 1:2 matching.Supplemental Figure 2: Overall survival in weighted cohorts.Supplemental Table 1: Comparison of inclusion and exclusion criteria with the CHAARTED trial.Supplemental Table 2: Codes for identification of diagnoses, drug prescriptions/administrations, and procedures in German claims data.Supplemental Table 3: Baseline characteristics in unmatched and matched cohorts, 1:2 matching.Supplemental Table 4: Overall survival in the CHAARTED trial and in German claims data, matched cohorts 1:2 matching.Supplemental Table 5: Baseline characteristics of weighted cohorts.Supplemental Table 6: Overall survival in the CHAARTED trial and in German claims data, weighted cohorts. Aims: Using German claims, the authors replicated the CHAARTED trial in metastatic hormone-sensitive prostate cancer. Methods: The authors identified metastatic hormone-sensitive prostate cancer patients replicating the inclusion/exclusion criteria of CHAARTED. Patients treated with docetaxel in combination with androgen deprivation therapy (ADT) at first line (docetaxel group) were compared with patients treated with ADT monotherapy (ADT mono group). After propensity score matching, overall survival was compared between the matched cohorts. Results: The authors included 441 patients. After propensity score matching, two equally sized matched cohorts of 74 patients each were compared in terms of overall survival. The hazard ratio (HR) was 0.71 (95% CI: 0.42–1.19), comparable to the HR in CHAARTED (HR: 0.72; 95% CI: 0.59–0.89). Conclusions: Using early comparative evidence from real-world data for regulatory and health technology assessment decisions is useful.

本数据集为发表于《比较效果研究杂志（Journal of Comparative Effectiveness Research）》的论文《打通肿瘤学临床试验与真实世界数据的鸿沟：基于德国医保理赔数据的疗效结果可重复性研究证据（Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data）》的同行评议补充材料。补充图1：1:2匹配队列的总生存期。补充图2：加权队列的总生存期。补充表1：与CHAARTED试验入组及排除标准的对比。补充表2：德国医保理赔数据（German claims data）中用于识别诊断、药物处方/给药及操作的编码集。补充表3：未匹配与1:2匹配队列的基线特征。补充表4：CHAARTED试验与德国医保理赔数据中1:2匹配队列的总生存期。补充表5：加权队列的基线特征。补充表6：CHAARTED试验与德国医保理赔数据中加权队列的总生存期。研究目的：本研究依托德国医保理赔数据，针对转移性去势敏感性前列腺癌患者复刻CHAARTED试验。研究方法：研究者筛选出符合CHAARTED试验入排标准的转移性去势敏感性前列腺癌患者，将一线接受多西他赛联合雄激素剥夺治疗（androgen deprivation therapy, ADT）的患者与仅接受雄激素剥夺单药治疗的患者分别设为多西他赛组与ADT单药组，经倾向得分匹配（propensity score matching）后对比两组匹配队列的总生存期。研究结果：本研究共纳入441例患者，经倾向得分匹配后得到2组各74例患者的匹配队列用于总生存期对比，其风险比（hazard ratio, HR）为0.71（95%置信区间（confidence interval, CI）：0.42~1.19），与CHAARTED试验中的风险比（HR=0.72；95%置信区间：0.59~0.89）具有可比性。研究结论：借助真实世界数据（real-world data）获取的早期比较证据，可有效应用于监管与卫生技术评估决策。