Menarini Silicon Biosystems, a pioneer of liquid biopsy and single cell technologies, announced the promising long-term results of the STIC trial, on OS (overall survival) in patients with ER+/HER2- MBC. This robust (n=755), randomized, multicenter phase III study aimed to compare the efficacy of a clinician- vs CTC-driven treatment choice. After meeting its primary endpoint on PFS (progression free survival) in 2018[1], follow-up data presented orally by Professor Francois-Clément Bidard at the 2022 San Antonio Breast Cancer Symposium (SABCS) on December 8th, demonstrates that a single assessment of CELLSEARCH CTC count before the start of treatment, may lead to increased OS in a metastatic setting2.
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According to FC Bidard, MD, PhD, Professor of Medical Oncology & Coordinator of Breast Cancer research at the Institut Curie hospitals, “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 (ET). When treated with chemotherapy (ChT) instead, these patients had a superior median OS of 16 months”. The trial further showed that, when escalated to ChT, these patients also experienced a 47% reduction in their risk of death. “This is the first ever trial to demonstrate the clinical utility of CTC count in MBC. It paves the way to integrating CTC count into treatment decision algorithms for patients who previously received CDK4/6 inhibitors as first line or adjuvant therapy, and for whom the decision between either a further line of ET or ChT is difficult, heterogeneous and controversial when based only on clinicians’ judgment” – he added.
Breast cancer is the most commonly diagnosed malignancy in women worldwide. Among various subtypes, HR+/HER2- is the most prevalent3 and improvement of long-term survival in MBC still remains a challenge.
CELLSEARCH is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast cancer when used in conjunction with other clinical monitoring methods. Because it can capture and enumerate CTCs from just 7.5 ml of peripheral blood, this assay represents a minimally invasive method, compared to more burdensome tumor biopsies, for informing treatment strategies. “We are thrilled by the positive results of our study on the more direct clinical benefit endpoint of OS” said Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems.
SOURCE: PR Newswire