Researchers from the Spanish National Cancer Research Center (CNIO) have made significant progress in understanding and treating HER2-negative breast cancer, the most common form of the disease. HER2-negative breast cancer is characterized by low levels of the HER2 protein, but its development varies widely among patients, making treatment challenging. A team led by Miguel Ángel Quintela, head of the Breast Cancer Clinical Research Unit at CNIO, has discovered that fibrosis in tumor tissue can serve as a key indicator of the disease’s progression.
Fibrosis, which is the hardening of the extracellular matrix surrounding tumor cells, has been linked to more aggressive cancer behaviors, including a higher likelihood of metastasis. Quintela’s team confirmed, through their recent study published in Clinical Cancer Research, that the presence of fibrosis is associated with a worse prognosis for HER2-negative breast cancer patients. This marks the first clinical study to conclusively demonstrate fibrosis as a strong negative prognostic factor.
MeCo Score®: A New Predictive Test
The study introduced a novel test called MeCo Score®, which evaluates gene activity in early-stage HER2-negative breast tumors. This test, developed by MeCo Diagnostics, a spin-off of the University of Arizona, analyzes around 1,000 genes, focusing on those related to fibrosis. The results establish a score that correlates with the extent of fibrosis in the tumor, with a higher score indicating a greater likelihood of relapse or metastasis.
This test could enable clinicians to classify tumors more accurately, helping them personalize treatment plans for patients. Quintela’s team believes that by identifying the level of fibrosis in tumors, doctors can make more informed decisions about the appropriate course of treatment. The study also paves the way for the MeCo Score® to potentially gain approval from the US Food and Drug Administration (FDA), though further clinical data is needed.
Potential for Nintedanib in Combination Therapy
New FDA-Approved Targeted Drug for Treatment-Resistant, ER Positive HER2 Negative Breast Cancer
The CNIO study went beyond identifying fibrosis as a prognostic factor. It also explored a promising treatment strategy involving the drug nintedanib, currently used to treat idiopathic pulmonary fibrosis. The researchers found that supplementing conventional chemotherapy with nintedanib could significantly improve outcomes for patients with high levels of fibrosis in their breast tumors.
This discovery builds on earlier work by Quintela’s group, which conducted a trial in 2014 involving 130 breast cancer patients. The trial investigated whether nintedanib, combined with chemotherapy, could prevent the formation of new blood vessels in tumors. When the University of Arizona Cancer Center, led by Gus Mouneimne, examined the drug’s ability to reduce fibrosis in breast cancer, they collaborated with Quintela’s team to analyze biopsy samples from 73 cases. The analysis confirmed that patients with higher fibrosis levels showed better responses to nintedanib, offering a potential new approach for treating HER2-negative breast cancer.
According to the researchers, this combined treatment with an Anti-Fibrotic Drug could lead to more personalized and cost-effective therapies, marking the first successful clinical application targeting tumor fibrosis in oncology. These findings offer hope for better outcomes in patients with fibrotic breast tumors and set the stage for further research into anti-fibrotic treatments in cancer care.
