A Multimodal Approach to Discover Biomarkers for Taxane-Induced Peripheral Neuropathy (TIPN): A Study Protocol.

Area of Science:

• Oncology
• Neuroscience
• Pharmacology

Background:

• Taxanes are crucial chemotherapy drugs for solid tumors, but commonly cause peripheral neuropathy, impacting treatment and quality of life.
• Taxane-induced peripheral neuropathy (TIPN) affects up to 70% of patients, leading to sensory and motor deficits.
• Current methods for predicting TIPN are insufficient, with limited understanding of its underlying mechanisms and few treatment options.

Purpose of the Study:

• To address the clinical need for early detection of patients at risk for TIPN.
• To develop comprehensive predictive biomarker signatures for TIPN using a multimodal approach.
• To enable personalized taxane treatment adjustments, minimizing TIPN-related morbidity and enhancing patient quality of life.

Main Methods:

• The Genetics and Inflammatory Markers for CIPN (GENIE) study is a longitudinal, multicenter observational study.
• It involves 400 breast cancer patients undergoing taxane therapy.
• A multimodal approach collects data on genomic variation, metabolites, DNA methylation, gene expression, and cytokines/chemokines before, during, and after treatment.

Main Results:

• This study is designed to identify comprehensive predictive biomarker signatures for TIPN.
• Analysis of multimodal data will correlate molecular profiles with TIPN development.
• Patient-reported outcomes will be integrated with molecular data to understand the patient experience of TIPN.

Conclusions:

• The GENIE study aims to provide a novel tool for early TIPN risk assessment.
• Findings will support modifications in taxane treatment strategies to mitigate neuropathy.
• The ultimate goal is to improve the quality of life for cancer patients undergoing taxane chemotherapy.