Researchers assessed tissue samples for fibrosis with the MeCo Score, a diagnostic method that may help predict the chances of relapse or recurrence in patients diagnosed with early-stage breast cancer.
A study published in Clinical Cancer Research has established that the stiffening of tissues in the most prevalent forms of breast cancer, specifically HER2-negative, can lead to disease progression and metastasis, ultimately resulting in negative outcomes for patients. This research was a collaborative effort between experts at the University of Arizona Health Sciences and medical practitioners in Spain.
A team led by Miguel Quintela-Fandino, MD, at the Spanish National Cancer Research Center, examined the MeCo Scoreâ„¢, a diagnostic tool developed at the University of Arizona, finding it has potential for predicting relapse or recurrence in early-stage breast cancer patients.
In cases where standard chemotherapy was the only treatment provided in the neoadjuvant context, high MeCo Scores correlated with significantly poorer survival rates compared to low MeCo Scores. However, this gap in survival rates diminished for patients receiving antifibrotic therapy alongside chemotherapy. For patients with high MeCo Scores, the addition of antifibrotic therapy lowered recurrence risk by 62%, with an average follow-up duration of 9.7 years post-treatment.
The original connection between breast cancer progression to bone metastasis and fibrosis was clarified in a 2021 study published in Cell Reports, authored by Ghassan Mouneimne, PhD, who is an associate professor of cellular and molecular medicine at the U of A College of Medicine — Tucson and of cancer biology at the Ginny L. Clements Breast Cancer Research Institute at the University of Arizona Cancer Center. This study recognized the MeCo Score as a prognostic biomarker in breast cancer, while the recent study positions it as a predictive biomarker for antifibrotic treatment benefits in HER2-negative breast cancer patients.
“Through our collaboration with colleagues in Spain, we discovered that an antifibrotic drug called nintedanib, which had no previously established advantage for breast cancer patients, provided improved outcomes when combined with standard chemotherapy,” said Mouneimne. “The MeCo Score played a vital role in this discovery.”
Mouneimne is optimistic that this research represents a significant step toward receiving approval from the U.S. Food and Drug Administration for the MeCo Score.
“We have a considerable amount of work ahead of us, as further clinical validation is necessary for FDA approval,” Mouneimne stated, “but this truly is a great advancement.”
Mouneimne previously established the relationship between fibrosis and advanced breast cancer stages, which provided the foundational knowledge needed for creating the MeCo Score and prompted the establishment of MeCo Diagnostics LLC, a startup focused on promoting the technology for clinical use. The development team, including Adam Watson, PhD, a former student of the U of A’s Cancer Biology program and current CEO of MeCo Diagnostics, collaborated with Tech Launch Arizona, the U of A office dedicated to commercializing research-based innovations, to secure the invention’s protection, strategize for the new company, and license the technology from the university.
“We are hopeful that further clinical validation of this discovery will establish a new method for identifying which patients may gain from this innovative therapeutic option,” Mouneimne explained. “As a drug expected to become generic, nintedanib is anticipated to significantly decrease in price over the next few years, which could help alleviate the rising costs associated with breast cancer treatment. Our focus is on finding new ways to tailor care and discover more affordable treatment options.”
“We are in the early phases of planning a prospective, multicenter trial that will use the MeCo Score to guide nintedanib treatment in patients with luminal, ER-positive breast cancer,” added Mouneimne.
Pavani Chalasani, MD, from the George Washington Cancer Center in Washington, D.C., will be the principal investigator for this trial. The aim is for the MeCo Score, derived from early biopsies, to assist patients in determining whether antifibrotic therapy would be beneficial prior to surgery in the neoadjuvant setting.
