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
Processing time: 204 Days and 6.2 Hours
ARTICLE HIGHLIGHTS
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.