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《比较有效性研究杂志》的论文《弥合肿瘤学临床试验与实际数据之间的差距：利用德国索赔数据对疗效结果可复制性的实证研究》的同行评审补充材料。补充图1：匹配队列的总体生存率，1:2匹配。补充图2：加权队列的总体生存率。补充表1：与CHAARTED试验的纳入和排除标准的比较。补充表2：德国索赔数据中诊断、药物处方/给药和程序识别的代码。补充表3：未匹配和匹配队列的基线特征，1:2匹配。补充表4：CHAARTED试验和德国索赔数据中匹配队列的总体生存率，1:2匹配。补充表5：加权队列的基线特征。补充表6：CHAARTED试验和德国索赔数据中加权队列的总体生存率。研究目的：利用德国索赔数据，作者们复制了针对转移性激素敏感性前列腺癌的CHAARTED试验。研究方法：作者们通过复制CHAARTED的纳入/排除标准，确定了转移性激素敏感性前列腺癌患者。接受一线治疗（多西他赛组）的患者与接受单药雄激素剥夺疗法（ADT单药组）的患者进行了比较。在倾向性评分匹配后，比较了匹配队列的总体生存率。研究结果：作者们纳入了441名患者。在倾向性评分匹配后，两个等大小的匹配队列，每队74名患者，在总体生存率方面进行了比较。风险比（HR）为0.71（95% CI：0.42–1.19），与CHAARTED中的HR（HR：0.72；95% CI：0.59–0.89）相当。研究结论：利用真实世界数据的早期比较证据为监管和医疗技术评估决策提供参考是有益的。