Daniel Rotroff, PhD, assistant staff, the Department of Quantitative Health Sciences, assistant professor of Medicine, the Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, discusses the investigation of biomarkers that could help identify patients with breast cancer who are at risk for developing chemotherapy-induced peripheral neuropathy.

The GENIE study was designed to develop a biomarker signature that could help predict which patients with breast cancer are at risk of developing peripheral neuropathy when receiving a taxane-based chemotherapy. Taxane-based chemotherapy is a common first-line treatment for patients with breast cancer, and approximately 70% of patients will experience peripheral neuropathy when undergoing this treatment, Rotroff explains.

Symptoms of peripheral neuropathy are described as tingling, numbness, or a burning sensation in the hands or feet, and for many patients, this will resolve within a few days following their infusion; however, for up to 20% of patients, symptoms of peripheral neuropathy can be severe and last long term, Rotroff continues. Peripheral neuropathy is one of the primary dose-limiting toxicities for taxane-based chemotherapy, which can lead to treatment discontinuation. Additionally, symptoms can persist for months or years after the treatment has ended, Rotroff emphasizes.

GENIE aims to identify which patients are at the greatest risk of developing persistent peripheral neuropathy or a severe dose-limiting toxicity to allow for early treatment adjustments so they can continue therapy, Rotroff says.

At the 2022 San Antonio Breast Cancer Symposium, investigators shared background and methods for the GENIE trial. The study is aiming to enroll 400 patients, and 206 patients have been enrolled thus far. During the observational study, investigators will collect patient-reported outcomes, and biomarkers will be examined in patients who do or do not experienced chemotherapy-induced peripheral neuropathy.

Rotroff explains that in data collected thus far, investigators were able to predict with approximately 84% accuracy which patients are at risk of developing moderate or severe peripheral neuropathy after receiving a taxane. By gathering genetic, transcriptional, epigenetic, and metabolic data, investigators are able to enroll a smaller amount of patients and still get a comprehensive look at biomarkers that could be associated with a higher risk of peripheral neuropathy, Rotroff concludes.

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Daniel Rotroff, PhD, discusses the investigation of biomarkers that could help identify patients with breast cancer who are at risk for developing chemotherapy-induced peripheral neuropathy.

Daniel Rotroff, PhD

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Dr. Rotroff on Biomarkers Associated With the Risk of Peripheral Neuropathy in Breast Cancer