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

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 r = 0.873; 95% CI: 0.849−0.897, Spearman’s r = 0.909; 95% CI: 0.893−0.925; Kendall’s Tau r = 0.831; 95% CI: 0.812−0.850, Fleischers’ r = 0.682; 95% CI: 0.601−0.764), mCRPC (Pearson’s r = 0.812; 95% CI: 0.758−0.865, Spearman’s r = 0.895; 95% CI: 0.868−0.923, Kendall’s Tau r = 0.789; 95% CI: 0.755−0.823, Fleischers’ r= 0.439; 95% CI: 0.334−0.544), and mCNPC (Pearson’s r = 0.931; 95% CI: 0.899−0.964, Spearman’s r = 0.943; 95% CI: 0.922−0.964, Kendall’s Tau r = 0.866; 95% CI: 0.836−0.896, Fleischers’ r = 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.

Keywords:

• Prostate cancer
• PFS2
• overall survival
• correlation
• MDV
• Japan

Transparency

Declaration of funding

Funding data acquisition, research, and preparation of the manuscript were funded by Janssen Pharmaceutical K.K. The funding body did not have any additional role in the study design, data collection, and analysis; decision to publish; or preparation of the manuscript.

Declaration of financial/other relationships

Wu David Bin-Chia: received grant from Pfizer; employee of Janssen Asia Pacific. Shiota Masaki: research funding support from Daiichi Sankyo Company, Ltd; received honoraria from Janssen Pharmaceutical K.K., AstraZeneca K.K., Sanofi, Bayer, Chugai, and Astellas Pharma Inc; received lecture fees from Janssen Pharma, AstraZeneca K.K., Sanofi, Bayer, Astellas Pharma Inc, and Sanofi. Yu Dae Young: employee of Janssen Korea. Koroki Yosuke: employee of Janssen Pharmaceutical K.K. and holds stock in Johnson & Johnson. De Moor Raf: employee of Janssen Japan.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors were involved in study design. All authors were involved in the interpretation of the results. David Bin-Chia Wu, Dae Young Yu were responsible for the statistical analyses. All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors meet International Committee of Medical Journal Editor (ICMJE) criteria, and all those who fulfilled those criteria are listed as authors. All authors provided direction and comments on the manuscript, made the final decision about where to publish these data, and approved submission to this journal.

Acknowledgements

The authors thank Salgo Merin Ricki Elenjikamalil, Ph.D. (SIRO Clinpharm Pvt. Ltd.) for providing writing assistance, and Lying Pei and Koki Idehara from IQVIA Solutions Japan, K.K. for conducting the analysis.