New UK DCIS trial aims to help women avoid unnecessary breast operations

Researchers at the University of Birmingham and University Hospitals Birmingham NHS Trust are launching a breast screening study that aims to improve the treatment of ductal carcinoma in situ (DCIS) by only operating on women who need surgery, rather than all of those who show signs of abnormal cells.

DCIS means that there are cancer cells lining the milk ducts in the breast, but they are contained in the ducts and cannot spread to other parts of the body, and of themselves they are not dangerous. However, DCIS is often a pre-cursor to invasive cancer and it is not possible to be certain which ones will progress. For this reason women with DCIS are usually treated in the same way as invasive breast cancer, including surgery. A Breast Screening Review carried out last year concluded that whilst the national breast screening programme undoubtedly saves lives the current approach with DCIS means that some women are also undergoing treatment, including surgery, unnecessarily.

Consultant Breast Surgeon, Mr Simon Marsh, explains this in the following way: "DCIS comes in three types: low, medium and high grade depending on how abnormal it is. High grade DCIS is very nearly cancer and would probably develop into proper cancer within a few years. So, if high grade DCIS is removed we are preventing someone from getting the breast cancer they would otherwise have developed. Medium grade DCIS may take a lot longer to develop into cancer and low grade DCIS may never get that far, but we are not sure. If DCIS is found, it will usually be removed."

The new study, called the LORIS trial (Low Risk DCIS Trial), will focus on DCIS that has been classified as low risk and will help clinicians learn which women with low risk DCIS can safely avoid surgery.

In the study participating patients with low risk DCIS will either receive surgical treatment or will be actively monitored without initial surgical treatment. Patients will be monitored for their quality of life and any psychological effects by researchers at Brighton and Sussex Medical School, a partnership between the Universities of Brighton and Sussex. It is hoped that the trial will show if it is just as safe not to operate on low risk DCIS as it is to operate on everyone, as is current practice.

Dr Daniel Rea, a medical oncologist at the University of Birmingham, who is helping to run the trial said: "This is a pro-screening trial. Breast screening is an effective way of reducing breast cancer deaths and is an important component of breast cancer treatment. The surgical approach to DCIS has not kept pace with the changes in the spectrum of breast disease brought about through both the introduction of screening and the on-going series of changes and improvements to the screening service that have been introduced.

"Screening saves lives - and this trial is a step towards strengthening the net benefits of the existing screening programme."

The LORIS trial, which is funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA), is being run through the CR-UK Clinical Trials Unit in Birmingham, and will recruit patients from hospitals from all parts of the UK. It will aim to identify almost 1,000 women who have been diagnosed with low risk DCIS to take part.

Anyone who wants more information about the trial should contact [email protected].


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