Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. May 20, 2022; 12(3): 107-112
Published online May 20, 2022. doi: 10.5662/wjm.v12.i3.107
Lutetium in prostate cancer: Reconstruction of patient-level data from published trials and generation of a multi-trial Kaplan-Meier curve
Andrea Messori
Andrea Messori, Department of HTA, ESTAR Toscana and Regione Toscana, Firenze 50139, Italy
Author contributions: Messori A is the sole author, read and approved the final manuscript.
Conflict-of-interest statement: The authors declare that they have no conflicts of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Andrea Messori, PharmD, Senior Researcher, Department of HTA, ESTAR Toscana and Regione Toscana, via Alderotti 26/N, Firenze 50139, Italy. andrea.messori.it@gmail.com
Received: October 26, 2021
Peer-review started: October 26, 2021
First decision: December 17, 2021
Revised: December 18, 2021
Accepted: March 16, 2021
Article in press: March 16, 2021
Published online: May 20, 2022

Lutetium has been shown to be an important potential innovation in pre-treated metastatic castration-resistant prostate cancer. Two clinical trials have evaluated lutetium thus far (therap and vision with 99 and 385 patients, respectively), but their results are discordant.


To synthetize the available evidence on the effectiveness of lutetium in pre-treated metastatic castration-resistant prostate cancer; and to test the application of a new artificial intelligence technique that synthetizes effectiveness based on reconstructed patient-level data.


We employed a new artificial intelligence method (shiny method) to pool the survival data of these two trials and evaluate to what extent the lutetium cohorts differed from one another. The shiny technique employs an original reconstruction of individual patient data from the Kaplan-Meier curves. The progression-free survival graphs of the two lutetium cohorts were analyzed and compared.


The hazard ratio estimated was in favor of the vision trial; the difference was statistically significant (P < 0.001). These results indicate that further studies on lutetium are needed because the survival data of the two trials published thus far are conflicting.


Our study confirms the feasibility of reconstructing patient-level data from survival graphs in order to generate a survival statistics.

Keywords: Survival analysis, Individual patient data reconstruction, Kaplan-Meier curves, Meta-analysis, Prostate Cancer, Lutetium

Core Tip: This paper describes the application of a new technique of individual-patient data reconstruction to the progression-free survival curves published in two trials evaluating lutetium in metastatic prostate cancer. Our analysis interpreted these survival data and showed discordant results between the two trials, that need to be addressed by further clinical research.