Menarini Silicon Biosystems has announced results of the long-term STIC trial for its CellSearch technology on the overall survival in patients with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2) metastatic breast cancer (MBC).
CellSearch is a minimally invasive blood test for detecting and counting circulating tumor cells (CTCs). It has been clinically validated and cleared by the U.S. Food & Drug Administration (FDA) for use in conjunction with other clinical monitoring in MBC.
The STIC trial is a long-term, multicenter, phase III study using data from 755 patients which aimed to compare the efficacy of CTC-driven and clinician-determined choices of endocrine therapy or chemotherapy.
The data were presented orally by Dr. Francois-Clément Bidard, PhD, professor of medical oncology and coordinator of breast cancer research at the Institut Curie hospitals, at the 2022 San Antonio Breast Cancer Symposium (SABCS) on December 8.
The data demonstrated that a single assessment of CTC count by CellSearch before treatment commences may lead to increased overall survival in patients with MBC, Menarini said.
“We were particularly impressed by the subgroup of patients with a low clinical risk profile and CTC count ≥5, for whom physicians, in line with guidelines, selected endocrine therapy. When treated with chemotherapy instead, these patients had a superior median [overall survival] of 16 months," said Dr. Bidard in a statement. “This is the first ever trial to demonstrate the clinical utility of CTC count in MBC.”
Earlier in December, Menarini announced the results from another study on the use of CellSearch on predicting disease pathology and aggressiveness in different stages of multiple myeloma.
