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
Research background

Two trials have been published to assess the effectiveness of lutetium in metastatic prostate cancer. The need to convert these effectiveness data into a pooled estimate represents a useful opportunity to test an innovative technique of individual patient reconstruction based on the analysis of Kaplan-Meier curves (shiny method).

Research motivation

The main motivation was to test the performance of the shiny method based on a real data-set.

Research objectives

Clarifying the effectiveness of lutetium in metastatic prostate cancer and confirm the reliability of the shiny method as a tool for reconstructing individual patient data.

Research methods

The clinical trials that have thus far evaluated lutetium in metastatic prostate cancer have been identified by standard literature search. A pooled survival curve has been generated from these trials by using the shiny technique of individual patient data reconstruction.

Research results

Two clinical trials were identified. A pooled Kaplan-Meier survival curve was generated that synthesizes the current evidence on the effectiveness of this treatment in this disease condition.

Research conclusions

A two-fold conclusion: First, lutetium is effective in metastatic prostate cancer; second, the Shiny technique can successfully be used to pool survival data from two trials without employing any meta-analytical method.

Research perspectives

The shiny technique has been confirmed to be a useful new tool for analyzing survival data from multiple trials and therefore deserves to be further applied in the analysis of clinical evidence.