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Study finds positive patient reported outcomes for single dose intra-operative radiotherapy (SD-IORT) for early stage breast cancer

20 Apr 2016
Study finds positive patient reported outcomes for single dose intra-operative radiotherapy (SD-IORT) for early stage breast cancer

A patient experience study of early stage breast cancer patients who opted for single dose intraoperative radiotherapy (SD-IORT), found positive patient reported outcomes for this treatment which is an alternative to standard daily external beam radiotherapy (EBRT).

All participants felt well supported through treatment decision making and patients reported less pain than anticipated.

After one month, 89% of patients rated their recovery as good, very good or excellent and 84% returned to full daily activities within four weeks of SD-IORT treatment.

For appropriate early stage breast cancer patients only, the ‘one dose, one treatment, one day’ radiotherapy option can eliminate the need for EBRT, which is typically administered five days a week, over the course of three to five weeks.

SD-IORT is administered at the point of surgery directly to the tumour bed following excision, sparing surrounding healthy tissue in the heart, lungs and ribs from radiation exposure.

Quality of life, patient satisfaction and convenience can be improved by giving patients the choice of SD-IORT.

However, despite an initial positive response by NHS England, SD-IORT is not yet routinely available in the UK.

Dr Richard Simcock, Consultant Clinical Oncologist, Sussex Cancer Centre said, “SD-IORT has an important place in breast cancer care and together with support from a multidisciplinary medical team, patients should have the option to choose the radiotherapy that is right for them. All too often treatment experience is overlooked or not deemed important. Breast cancer patients should be able to make an informed choice on the course of treatment they would prefer, particularly after an often traumatic diagnosis.”

Every year, more than 50,000 women in the UK are diagnosed with breast cancer, of whom around four out of five will have early stage disease. 

More than half of women having surgery for breast cancer have a breast conserving procedure, usually followed by radiotherapy.

Radiotherapy is estimated to contribute to 40% of cases where cancer is cured.

Breast cancer accounts for approximately 30% of radiotherapy departments’ workload, so IORT could relieve some of the demand.

The practical challenges of attending radiotherapy treatment courses are often underestimated, and some patients are deterred by long travel times or high costs associated with attending daily EBRT appointments.

The cost of travel to and from appointments affects 69% of people with cancer and costs them, on average, £170 a month.

“The study we conducted among our patients at the Spire Montefiore hospital in Hove, East Sussex demonstrates that women who choose SD-IORT report a positive treatment experience with many returning to normal daily activities very quickly. Single dose IORT provides an effective alternative for appropriate patients which is well tolerated with few side effects,” Said Dr Charles Zamitt, Consultant Breast & Endocrine Surgeon; Honorary Senior Lecturer Brighton and Sussex Medical School, who led the study. 

The efficacy of SD-IORT was examined in a Phase III, randomised non-inferiority clinical study, which demonstrated that the recurrence of breast cancer in patients who had received a single-dose of IORT was comparable to the recurrence of breast cancer in patients who had received EBRT (2.1% vs. 1.1% at 5-years).

The frequency of major adverse events and complications was comparable in both groups, although SD-IORT was better tolerated overall than daily radiotherapy.

As more clinical experience and data becomes available, the procedure is being used more frequently globally due to the patient benefits compared to conventional radiotherapy.

Over 70 breast cancer patients have been treated with SD-IORT in the UK.

SD-IORT is a targeted radiotherapy which reduces exposure of surrounding healthy tissue to radiation, provides better cosmetic results than EBRT and enables patients to receive treatment promptly.

Women with breast cancer are usually ‘fit to treat’ with EBRT 21 days following final surgery.

The median number of days from final surgery to radiotherapy was 59 days in England.

In the UK, Oncotherapy Resources Ltd (ORL) provides SD-IORT.

Through the unique mobile, managed radiotherapy service, ORL is able to deliver targeted radiotherapy directly to the patient at the hospital of their choice.

ORL works on a 72-hour notice basis, meaning patients can access required treatment in just a few days.

“Our aim is to give patients the choice SD-IORT at the point of surgery, providing them with an effective and convenient treatment experience. SD-IORT helps patients return to normal daily life more easily and quickly,” said Sarah-Kate Williams, Lead Radiographer, Oncotherapy Resources. “ORL's SD-IORT service provides a flexible and cost-effective solution for health service providers in reducing pressure on EBRT services as the demand for radiotherapy continually increases,” she added.

SD-IORT is not currently available on the NHS.

NHS England has decided to wait until more clinical trial data becomes available before making a decision on commissioning.

The NICE appraisal committee is currently reviewing IORT following positive draft guidance released in July 2014.

Early stage breast cancer patients should have the choice between SD-IORT and EBRT based on the current clinical and real-world evidence available.

However, it is important to note that there is a lack of comparative outcome data between IORT and EBRT at present.

Source: Oncotherapy Resources