NICE develops Medtech Innovation Briefing for Single Dose Intraoperative Radiotherapy using Xoft Axxent electronic brachytherapy system for early stage breast cancer.

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NICE (National Institute for Health and Care Excellence) has announced a new Medtech Innovation Briefing (MIB)1 stating that NHS doctors and commissioners may consider Single Dose Intraoperative Radiotherapy (SD-IORT) using the Xoft Axxent electronic brachytherapy system with ORL managed service as a treatment option for early stage breast cancer patients.

NICE (National Institute for Health and Care Excellence) has announced a new Medtech Innovation Briefing (MIB)1 stating that NHS doctors and commissioners may consider Single Dose Intraoperative Radiotherapy (SD-IORT) using the Xoft Axxent electronic brachytherapy system with ORL managed service as a treatment option for early stage breast cancer patients.

The ORL managed pay per use Axxent Electronic Brachytherapy (eBx) System delivers SD-IORT (Single Dose Intraoperative Radiotherapy) during breast-conserving surgery (BCS) to treat early stage breast cancer. Patients who would benefit from SD-IORT include those that are 50 years or older with small low-grade tumours. For most patients, SD-IORT eliminates the need for post-operative radiotherapy, avoiding the inconvenience, disruption and expense of attending daily hospital appointments for several weeks. Women who receive SD-IORT rather than EBRT have been shown to experience less pain, breast and arm symptoms, as well as fewer restrictions in daily activities.

Benefits include:

  •     Surgery and radiotherapy in just one day.
  •     Reduces exposure of surrounding normal tissue to radiation dose.
  •     Provides better cosmetic results.
  •     For most patients, SD-IORT eliminates the need for post-operative radiotherapy.
  •     Offers improved quality of life and convenience compared to EBRT.
  •     SD-IORT can be offered in multiple hospitals including those that do not have specialist radiotherapy centres.

The NICE MIB states that the Oncotherapy Resources Limited eBx would fit in the current NHS pathway, in place of external beam radiotherapy (EBRT), alleviating the need for patients to attend daily radiotherapy for 3 weeks. One of the MIB specialist commentators noted that SD-IORT was well tolerated with a low rate of adverse events and excellent to good cosmetic outcomes. As it is a portable platform SD-IORT can be delivered in a greater number of hospitals, including those that do not have specialist radiotherapy centres which improves accessibility and convenience for the patient. The MIB also states that the cost per patient of the ORL’s managed service is only £3,750 (excluding VAT). There is no capital equipment purchase, maintenance cost or servicing charge. In comparison, external beam radiotherapy costs £3,433 per patient (15 fractions) in addition to the initial purchase and maintenance costs of a linear accelerator.

Mr Charles Zammit, Consultant Breast & Endocrine Surgeon; Honorary Senior Lecturer Brighton and Sussex Medical School explained “Single dose IORT provides an effective alternative for my selected patients which is well tolerated. I want to be able to offer SD-IORT as a treatment option to all of my eligible patients and hope that informative documents such as this MIB will pave the way for as many as possible to benefit”.

Dr Amit Bahl, Consultant Clinical Oncologist, Bristol Haematology and Oncology centre stated that: “The NICE MIB provides clinicians and hospitals the option to be able to offer their suitable early breast cancer patients a fast, effective and convenient alternative to EBRT without the need for large investment in expensive equipment and the associated staffing issues. Suitable patients should be able to access Single Dose IORT more easily and can be afforded the choice of which treatment is right for them. Whilst exciting further research with this technology is in progress, SD-IORT is particularly important for several patients who would wish to avoid three weeks of whole breast radiotherapy which is often only available at a regional centre.”

SD-IORT helps patients return to normal daily life more easily and quickly. ORL's SD-IORT service provides a flexible and cost-effective solution for healthcare providers in reducing pressure on breast radiotherapy services whilst providing added benefits to patients.

About SD-IORT
SD-IORT is a single dose of radiotherapy delivered at the time of breast conserving cancer surgery. SD-IORT is applied directly to the tumour bed immediately following wide local excision and while patients are still under anaesthetic, sparing surrounding healthy tissues from radiation exposure and eliminating the need for post-operative radiotherapy in most patients. Patients who may benefit from SD-IORT include women aged 50 years or older with early stage breast cancer and tumours of 3cm or less in size.

About ORL
ORL aims to bring mobile, managed, radiotherapy services closer to patients. In the UK, breast cancer patients have benefited from ORL’s SD-IORT in several private hospitals across Spire, BMI and Nuffield health hospital groups. ORL’s single dose radiotherapy treatment is expertly delivered at the point of surgery, offering patients a convenient and effective treatment experience.

About Xoft
The Xoft® Axxent eBx System is FDA cleared, CE marked and licensed in a growing number of countries including the UK for the treatment of cancer2,3. The Xoft® Axxent eBx System is a simple-to-use, portable SD-IORT device, which utilises a disposable miniature x-ray tube (50kV). Minimal radiation shielding is required, avoiding the need to adjust operating theatres and enabling medical personnel to remain with the patient during treatment.
For more information on Xoft® please visit: http://www.xoftinc.com/

About NICE MIB’s
NICE Medtech innovation briefings (MIBs) are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The briefings will help avoid the need for organisations to produce similar information locally, saving staff time and resources. The information provided includes a description of the technology, how it’s used and it's potential role in the treatment pathway.
A MIB also includes a review of relevant published evidence and the likely costs of using the technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.
MIBs are commissioned by NHS England and produced in support of the NHS 5-Year Forward View, specifically as one of a number of steps, which will accelerate innovation in new treatments and diagnostics.
Follow this link to read the full NICE MIB - https://www.nice.org.uk/advice/mib76
For general enquiries and to find out more about SD-IORT with ORL’s mobile managed service please contact:

E: info@oncotherapyresources.com

T: 0774 279 0340

References
1.NICE National Institute for Health and Care Excellence. Medtech Innovation Briefings. Available at:https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/medtech-innovation-briefings. Last accessed: July 2016
2.U.S. Food and Drugs Administration. Tab 5 510 (k) Summary k090914. July 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/k090914.pdf. Last accessed July 2016.
3.Medical Devices Safety Service. Certificate of CE Marking for Xoft Inc. 2 December 2011. Available on request.

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Sarah-Kate Williams
@SD_IORT
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