Reproduce IMpower133 Clinical Trial Results

Provides functions to simulate baseline characteristics, reconstruct overall survival data from published Kaplan-Meier curves, and generate publication-ready tables and forest plots reproducing the IMpower133 clinical trial results (Horn et al., 2018, ). The IPD reconstruction method is based on Liu et al.(2021, ).

impower133

Reproduce the IMpower133 Clinical Trial Results

Overview

The impower133 package provides functions to reproduce the results of the IMpower133 clinical trial (Horn et al., 2018, NEJM), a phase III randomized controlled trial evaluating atezolizumab plus chemotherapy versus placebo plus chemotherapy in extensive-stage small-cell lung cancer.

This package was developed as a course project for the Biostatistics course at East China Normal University.

Installation

install.packages("impower133")

Or install the development version from GitHub:

remotes::install_github("fanfande131/impower133")

Functions

rtriang() - Triangular distribution random number generator

simulate_impower133() - Simulate complete ITT population with baseline, efficacy, and safety data

reconstruct_survival() - Reconstruct individual patient data from published K-M curves

analyze_survival() - Analyze survival data and print key statistics

plot_survival() - Plot K-M survival curves for OS or PFS

make_table1() - Generate Table 1: Baseline characteristics

make_table2() - Generate Table 2: Response rate and disease progression

make_table3() - Generate Table 3: Adverse events

plot_figure2c() - Generate Figure 2C: Subgroup forest plot

Usage

See inst/examples/test_impower133.R for a complete example. Simulated data, output figures (tables and plots), and the reconstructed IPD data are also available in inst/examples/.

Data Sources

The individual patient data was reconstructed from published Kaplan-Meier curves using the IPDfromKM web application:

https://biostatistics.mdanderson.org/shinyapps/IPDfromKM/

Method reference: Liu N, Zhou Y, Lee JJ. IPDfromKM: reconstruct individual patient data from published Kaplan-Meier survival curves. BMC Med Res Methodol. 2021;21(1):111.

Trial Reference

Horn L, Mansfield AS, Szczesna A, et al. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018;379:2220-2229. doi:10.1056/NEJMoa1809064

License

MIT