Reproduce IMpower133.

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.