TY - JOUR
T1 - 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
AU - Shiota, Masaki
AU - De Moor, Raf
AU - Koroki, Yosuke
AU - Yu, Dae Young
AU - Wu, David Bin Chia
N1 - Funding Information:
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.
Funding Information:
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.
Publisher Copyright:
© 2022 Janssen Pharmaceutical K.K. Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
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U2 - 10.1080/03007995.2022.2096353
DO - 10.1080/03007995.2022.2096353
M3 - Article
C2 - 35770513
AN - SCOPUS:85134180771
SN - 0300-7995
VL - 38
SP - 1351
EP - 1359
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 8
ER -