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In conducting a survival meta-analysis, the typical methodological approach analyses the hazard ratios (HRs) of individual trials and then combines them into a pooled meta-analytical estimate. The length of follow-up of individual trials is not generally accounted for. Recent techniques aimed at individual patient-data reconstruction from Kaplan-Meier graphs represent an important methodological innovation. These techniques permit the combination of the survival curves published in a single clinical trial but are also applicable to more than one trial. In the case of multiple trials, a meta-analysis can be conducted without using any statistical model of meta-analysis.  Methods  As an example of this new approach, we applied a technique of individual patient data reconstruction to the Kaplan-Meier graphs of overall survival reported in two phase-III trials, which were conducted on patients with locally advanced/advanced non-small cell lung cancer selected according to their PD-L1 expression status, not previously treated for their metastatic disease. Only subjects with PD-L1 ≥50% were considered for our analysis. The experimental arms received pembrolizumab monotherapy while the control arms were given platinum-based chemotherapy. The survival graphs were obtained for both trials. For each Kaplan-Meier curve, the graph was firstly digitalized. Then, the Shiny package was used to reconstruct patient-level data. Finally, the pooled survival curves were generated from the reconstructed patient-level data along with the relevant Cox statistics; for this purpose, we used three packages (“coxph”, “survfit”, and “ggsurvplot”) under the R-platform.  Results  In our pooled analysis based on this procedure, we compared 453 patients given pembrolizumab vs. 451 controls given chemotherapy. The HR estimated from reconstructed patient-level data was 0.670 (95% confidence interval [CI], 0.566 to 0.793).  Conclusion  The analysis described herein demonstrates the easy applicability of the Shiny technique. This technique was successful in generating a pooled survival graph for the experimental treatment groups vs. controls and efficiently estimated the pooled HR in which the results of the two trials were combined.

Synthetizing Published Evidence on Survival by Reconstruction of Patient-Level Data and Generation of a Multi-Trial Kaplan-Meier Curve