Advice

The technology

The technology

The Axxent eBx system (Xoft) is a mobile platform for treating early‑stage breast cancer. It can also be used to treat non-melanoma skin cancer and gynaecological cancers, but these uses are beyond the scope of this briefing. It uses an isotope-free miniaturised X-ray source, which generates a 50 Kv photon spectrum in order to deliver single-dose intraoperative radiotherapy (SD‑IORT).

Patients have SD‑IORT immediately following breast-conserving surgery, before the surgery is completed and while the patient is still under general anaesthetic. A saline-filled balloon-shaped applicator is placed into the breast tissue where the tumour was removed, at the tumour bed. A single dose of 20 gray (Gy) X-ray radiation is delivered from the generator to the balloon surface, from where it is passed on to the breast tissue. Once SD‑IORT has been delivered, the single-use disposable applicator is removed and the surgery can be completed.

Delivery of SD‑IORT using the Axxent eBx system takes approximately 10 minutes and generally adds up to 40 minutes to the total breast-conserving surgery procedure.

The innovation

Axxent eBx allows SD‑IORT to be delivered at local or regional hospitals at the point of surgery.

The Axxent eBx system does not use isotopes and so there are minimal radiation protection implications and no bespoke construction or specialist shielding is needed. Treatment with the system is done through a managed service agreement, which avoids the cost of capital equipment purchase, maintenance costs or service charges; the only direct costs are per-patient treatment costs.

Current standard practice with external beam radiotherapy (EBRT) for breast cancer involves, post-operatively, 3 weeks of daily radiotherapy sessions. SD‑IORT treatment with the Axxent eBx system is given once at the time of surgery. The system is also designed to allow for targeted radiotherapy, the aim of which is to spare surrounding tissues from radiation exposure. Standard EBRT is delivered to the whole breast. Furthermore, because it is a mobile platform, Axxent eBx can be used to deliver SD‑IORT in multiple hospitals, including those that do not have specialist radiotherapy centres.

Current NHS options

For early‑stage breast cancer, breast-conserving surgery is usually the first treatment option (NHS Choices). The NICE guideline on early and locally advanced breast cancer: diagnosis and treatment recommends that patients should have EBRT after surgery to destroy any remaining cancer cells. This should be delivered as 40 Gy in 15 fractions (5 days for 3 weeks).

NICE is aware of the following CE-marked device that appears to fulfil a similar function to the Axxent eBx system:

  • Intrabeam (Zeiss).

NICE is currently developing guidance on the intrabeam radiotherapy system for the adjuvant treatment of early breast cancer.

Population, setting and likely place in therapy

The Axxent eBx system would be used in secondary care for people with early‑stage breast cancer who are offered SD‑IORT as an alternative to EBRT. Detailed selection would apply in such cases which are outside the scope of this briefing.

Axxent eBx is provided in the UK as a managed service by Oncotherapy Resources. The referrer for treatment with the Axxent eBx system would either be the breast surgeon responsible for the patient, or the clinical oncologist who prescribed the radiotherapy dose. The surgeon doing the breast surgery must be trained and certified in SD‑IORT by Oncotherapy Resources, and should observe at least 1 procedure before doing their own. Oncotherapy Resources provides a qualified mentor to oversee the first treatment in theatre who will then certify the surgeon if deemed competent.

SD‑IORT using the Axxent eBx system is done by a certified Oncotherapy Resources radiographer, whose time is provided within the cost of the service. They act as the radiation protection supervisor (RPS) in accordance with ionising radiation regulations (including for medical exposure). Before treatment, the operator (as the RPS) and local radiation protection advisor (RPA) liaise with Oncotherapy Resources' own RPS and RPA representatives to agree local rules, risk assessment and employer liability. The Ionising Radiation (Medical Exposure) Regulations require that a medical physics expert is also involved.

The Axxent eBx system will fit in the current NHS pathway during breast-conserving surgery for early‑stage breast cancer in patients for whom SD‑IORT is offered and would replace post-operative EBRT.

Costs

Device costs

The list price per patient of SD‑IORT with the Axxent eBx system is £3,750 (excluding VAT). No capital equipment purchase is needed, and there are no maintenance costs or service charges. The list price for the service includes:

  • machine delivery to and collection from the hospital

  • machine calibration and testing

  • a mobile lead screen

  • radiation protection documentation and advice

  • a treatment dose of 20 Gy

  • a sterile balloon applicator

  • a certified radiographer to deliver treatment in theatre.

Costs of standard care

The NHS costs (HRG codes) for a standard course of EBRT delivered 5 days per week for 3 weeks (15 fractions) are:

  • SC23Z – Deliver a fraction of complex treatment on a megavoltage machine: £1,980.

  • SC52Z – Preparation for complex conformal radiotherapy: £1,453.

The costs above exclude the initial purchase of a linear accelerator and maintenance. These costs vary depending on usage and specification but, on average, linear accelerators cost around £1.4 million to purchase with an equivalent running cost over a 10‑year lifespan (National Audit Office 2011).

Resource consequences

The Axxent eBx system is available to but not currently used in any NHS centre. However, it is being used by several private hospitals.

The main resource consequence would be training (provided by Oncotherapy Resources at no additional charge) for the surgeon to carry out a procedure, which will involve SD‑IORT delivered by an Oncotherapy Resources operator. Few adjustments are needed in theatre to deliver SD‑IORT in addition to standard breast-conserving surgery, although it adds 30 to 40 minutes to the procedure.