Menarini Silicon Biosystems, a pioneer of liquid biopsy and single-cell technologies, announced the recent publication of the STIC CTC trial data demonstrating the clinical utility of CTC count as an independent prognostic factor in advanced breast cancer.

More specifically, the STIC CTC trial demonstrates that the use of CTC count as a tool for choosing between endocrine therapy (ET) and chemotherapy (CT) is non-inferior to the investigator's choice in terms of short and long-term clinical outcomes. While approximately 60% of the study participants had a concordant indication between the clinical risk-guided arm and the CTC-guided treatment arm, in the subgroup of patients with a discordant estimate, the use of frontline CT in the CTC-guided treatment arm instead of ET yielded a clinically and statistically significant gain of 16.4 months in median overall survival (OS). Conversely, in the subgroup of patients considered at high clinical risk but with a favorable prognosis according to CTC count, de-escalation to ET allowed to limit the exposure to the side effects and toxicities of chemotherapy without any significant effect on overall survival.

FC Bidard, MD, PhD, Professor of Medical Oncology at the Institut Curie hospitals and who designed the trial mentioned, "the STIC trial is a first-of-its-kind randomized Phase III trial establishing with a high level-of-evidence that CTC-driven choice offers a long-term OS benefit in patients with discrepant estimates between their CTC count and the clinician's choice."

In addition, the Principal Investigator of the STIC CTC trial, Jean-Yves Pierga, MD, PhD, Professor of Medical Oncology, at the Institut Curie hospitals, "the clinical relevance of CTCs as highlighted in the STIC CTC trial, makes it possible to standardize the choice of ET or CT and meaningfully optimize patient care with a 47% reduction in the risk of death in patients with poor prognosis". 

In the metastatic setting, expectations regarding confirmatory prospective clinical trials to incorporate CTC data into clinical practice have been high for almost two decades now. According to Massimo Cristofanilli, MD, FACP, Professor of Medicine & Director of Breast Medical Oncology in the Division of Hematology and Medical Oncology at Weill Cornell Medicine, "The STIC CTC trial is the first robust clinical trial that has met those expectations by demonstrating the usefulness of CTC count as both a prognostic and predictive biomarker. Thus, there is no rational reason to deny women with MBC the right to benefit from this information that can help their physicians prescribe therapies that can more optimally meet their specific needs".

Liquid biopsies aim to provide critical information in real time to enhance the precision oncology approach. Fabio Piazzalunga, President of Menarini Silicon Biosystems, adds that "the confirmed ability of our minimally invasive CELLSEARCH CTC test, to help identify low-risk patients and avoid unnecessary treatments, is currently at the heart of the reimbursement requests, now underway in different countries, for use of this biomarker to tailor treatment strategies in an advanced disease setting". These new activities fully support the company's vision to become a leader in minimally invasive cell-based applications for easier, faster, and more precise diagnostic and therapeutic approaches.