利用日本医疗数据视觉（MDV）理赔数据库评估晚期前列腺癌患者的第二次无进展生存期（PFS2）和总生存期（OS）的相关性。

Assessing the correlation between second progression-free survival (PFS2) and overall survival (OS) in advanced prostate cancer patients using medical data vision (MDV) claims database in Japan.

机构信息

Department of Urology, Graduate School of Medical Sciences, Kyushu University Hospital, Fukuoka, Japan.

Integrated Market Access, Janssen Pharmaceutical KK, Tokyo, Japan.

出版信息

Curr Med Res Opin. 2022 Aug;38(8):1351-1359. doi: 10.1080/03007995.2022.2096353. Epub 2022 Jul 13.

DOI:10.1080/03007995.2022.2096353

PMID:35770513

Abstract

OBJECTIVE

To assess the correlation between PFS2 and OS among patients with advanced prostate cancer (PC) in a real-world setting for Japan.

METHODS

This was a retrospective analysis using the Japanese MDV database. Patients with nmCRPC (non-metastatic Castration-Resistant PC), mCRPC (metastatic Castration-Resistant PC), and mCNPC (metastatic Castration-Naïve PC) were identified and their medical records were investigated for PFS2 and death. Association between PFS2 and OS was determined using the Pearson's, Spearman's, Kendall's Tau, and Fleischers' correlation coefficients.

RESULTS

A total of 386,484 patients with PC were identified from the database, of which, 1,783 patients with nmCRPC, 630 with mCRPC, and 454 with mCNPC met the predefined eligibility criteria. Significant correlation between PFS2 and OS was observed in patients with nmCRPC (Pearson's = 0.873; 95% CI: 0.849-0.897, Spearman's = 0.909; 95% CI: 0.893-0.925; Kendall's Tau = 0.831; 95% CI: 0.812-0.850, Fleischers' = 0.682; 95% CI: 0.601-0.764), mCRPC (Pearson's = 0.812; 95% CI: 0.758-0.865, Spearman's = 0.895; 95% CI: 0.868-0.923, Kendall's Tau = 0.789; 95% CI: 0.755-0.823, Fleischers' = 0.439; 95% CI: 0.334-0.544), and mCNPC (Pearson's = 0.931; 95% CI: 0.899-0.964, Spearman's = 0.943; 95% CI: 0.922-0.964, Kendall's Tau = 0.866; 95% CI: 0.836-0.896, Fleischers' = 0.756; 95% CI: 0.624-0.888).

CONCLUSIONS

The results of this study indicate a significant correlation between PFS2 and OS, which adds additional evidence to the existing literature of using PFS2 as a surrogate endpoint for OS in patients with PC.

摘要

目的

评估在日本真实环境中，PFS2 与 OS 之间的相关性在晚期前列腺癌（PC）患者中的相关性。

方法

这是一项使用日本 MDV 数据库的回顾性分析。确定了 nmCRPC（非转移性去势抵抗性 PC）、mCRPC（转移性去势抵抗性 PC）和 mCNPC（转移性去势敏感性 PC）患者，并对其 PFS2 和死亡记录进行了调查。使用 Pearson、Spearman、Kendall's Tau 和 Fleischers 相关系数来确定 PFS2 和 OS 之间的关联。

结果

从数据库中确定了 386484 名 PC 患者，其中 1783 名 nmCRPC 患者、630 名 mCRPC 患者和 454 名 mCNPC 患者符合预定的入选标准。在 nmCRPC 患者中观察到 PFS2 和 OS 之间存在显著相关性（Pearson's = 0.873；95%CI：0.849-0.897，Spearman's = 0.909；95%CI：0.893-0.925；Kendall's Tau = 0.831；95%CI：0.812-0.850，Fleischers' = 0.682；95%CI：0.601-0.764）、mCRPC（Pearson's = 0.812；95%CI：0.758-0.865，Spearman's = 0.895；95%CI：0.868-0.923，Kendall's Tau = 0.789；95%CI：0.755-0.823，Fleischers' = 0.439；95%CI：0.334-0.544）和 mCNPC（Pearson's = 0.931；95%CI：0.899-0.964，Spearman's = 0.943；95%CI：0.922-0.964，Kendall's Tau = 0.866；95%CI：0.836-0.896，Fleischers' = 0.756；95%CI：0.624-0.888）。