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This project analyzes a randomized phase III clinical trial evaluating the efficacy and safety of panitumumab combined with FOLFOX4 chemotherapy as a first-line treatment for metastatic colorectal cancer (mCRC). It includes survival analysis, adverse event assessment, and statistical modeling based on patient KRAS status.

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Biostatistics Project: Randomized Phase III Study of Panitumumab with FOLFOX4 for First-Line Treatment of Metastatic Colorectal Cancer

Authors: Lucia Maninetti, Arianna Rigamonti, Michele Sala, Jacopo Tettamanti

This repository contains code and data related to a randomized phase III study evaluating the efficacy and safety of panitumumab in combination with FOLFOX4 compared to FOLFOX4 alone as first-line treatment for metastatic colorectal cancer (mCRC). Below is a brief overview of the study and the contents of this repository.

Abstract

The study, named the Panitumumab Randomized Trial in Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy (PRIME), aimed to assess the efficacy and safety of panitumumab-FOLFOX4 combination therapy compared to FOLFOX4 alone as initial treatment for mCRC. Key findings include significant improvements in progression-free survival (PFS) in patients with wild-type (WT) KRAS tumors treated with panitumumab-FOLFOX4 compared to FOLFOX4 alone. This README provides an overview of the statistical analysis conducted on the trial data.

Contents

  • Data Analysis Scripts: The Biostat_project.Rmd file contains R code for data analysis, including survival analysis, descriptive statistics, and graphical representations of the study results.
  • Data: The data folder contains the Excel file colon.xlsx, which includes patient data used in the analysis.
  • README: This README file provides an overview of the project and instructions for running the analysis code.

How to Use

To reproduce the analysis:

  1. Clone this repository to your local machine.
  2. Install R and the necessary R packages listed in the Biostat_project.Rmd file.
  3. Open the Biostat_project.Rmd file in RStudio or any other Markdown editor.
  4. Run the code chunks in the document sequentially to reproduce the analysis and generate the results.

For any questions or issues, please contact the authors.

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This project analyzes a randomized phase III clinical trial evaluating the efficacy and safety of panitumumab combined with FOLFOX4 chemotherapy as a first-line treatment for metastatic colorectal cancer (mCRC). It includes survival analysis, adverse event assessment, and statistical modeling based on patient KRAS status.

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