Receive our newsletter – data, insights and analysis delivered to you
  1. News
November 10, 2020

Menarini Silicon’s trial data supports CTC count reliability

Menarini Silicon Biosystems has published data from a Phase III STIC CTC study that supported the reliability of using circulating tumour cell (CTC) count to guide frontline therapy choice for patients with estrogen receptor-positive (ER+), HER2-negative (HER2) metastatic breast cancer. 

Menarini Silicon Biosystems has published data from a Phase III STIC CTC study that supported the reliability of using circulating tumour cell (CTC) count to guide frontline therapy choice for patients with estrogen receptor-positive (ER+), HER2-negative (HER2) metastatic breast cancer.

For detecting and counting CTCs, Menarini Silicon Biosystems’ CELLSEARCH CTC System, a clinically validated blood test approved by the Food and Drug Administration (FDA) was used.

The test helps physicians to manage patients with metastatic breast, prostate, and colorectal cancers when used along with other clinical methods of monitoring.

The randomised trial was conducted on 778 women with Stage 4 ER+, HER2- breast cancer and the outcomes of treatment decisions were compared based on physician assessment versus CTC count.

In the trial, patients in the clinically driven treatment group received treatment selected by a physician based on clinical factors.

In the CTC-driven treatment group, patients with five or more CTCs in 7.5ml of blood received chemotherapy and those with less than five CTCs in 7.5ml received hormone therapy.

Content from our partners
Small and simple: how medical device manufacturers select materials
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

CELLSEARCH system was used to capture and isolate tumour cells, circulating in the blood in all patients.

The results supported the reliability and clinical utility of using the CTC count to guide front line therapy choice.

The CTC count for most patients in the clinically driven group correlated with the physician’s treatment choice.

In the CTC-driven group, progressing treatment to frontline chemotherapy for patients with high CTC count significantly improved progression-free survival (PFS).

Moreover, for patients with low CTC count, de-escalation to hormone therapy did not have a detrimental impact on PFS or overall survival (OS).

Menarini Silicon Biosystems president and CEO Fabio Piazzalunga said: “The results of the STIC CTC study provide evidence that the CTC count can support physicians when making effective treatment decisions.”

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU