The National Institute for Health and Care Excellence (NICE) has published draft guidance on the use of intrabeam radiotherapy as a treatment option for people with early breast cancer[1]. It says that the radiotherapy treatment should be recommended for NHS funding provided patients are properly informed about its pros and cons and that further data are collected.

Professor Carole Longson, director of health technology evaluation at NICE, said the treatment has the potential to be a much more efficient form of radiotherapy: “Unlike regular radiotherapy, with the Intrabeam Radiotherapy System only one dose is required.

“This single dose is given at the same time as surgery, eliminating the need for numerous hospital visits. Regular radiotherapy typically requires numerous doses over a 3 week period – although some people may receive it for longer - and is performed weeks or months after surgery or chemotherapy.

“The Appraisal Committee concluded that whilst current evidence was not extensive, this type of radiotherapy was more convenient for patients and can improve a person’s quality of life.”

Just over 41,500 women and 300 men in England are diagnosed with breast cancer every year[2]. Figures suggest that about 86% of them - 35,970 people each year - will potentially have early breast cancer[3].

The draft guidance, published for consultation, says that intrabeam radiotherapy should be offered to NHS patients as long as doctors:

• explain the full range of treatment options available to patients, and their associated risks and benefits. This is to allow patients to make an informed decision about whether to choose Intrabeam or conventional radiotherapy.

• enter details about all of their breast cancer patients having treatment with the Intrabeam Radiotherapy System onto a national register[4].
  • audit, review and document clinical outcomes locally and consider the relationship between outcomes and patients’ characteristics.

“It’s still a new treatment,” Professor Longson explained. “So far, only 6 centres in the UK have used the Intrabeam Radiotherapy System to treat early breast cancer.

“Because it is still relatively new it is only right to recommend its use in a carefully controlled way. This will ensure patients are fully aware of the risks and benefits before choosing which treatment to have and allow doctors to gather more information about the treatment.”

The institute’s public consultation runs until Friday 15 August 2014. Final guidance is expected to be published in November 2014. Until then, local NHS bodies are expected to make their own funding decisions for new treatments.

Ends

Notes to Editors

Explanation of terms

1. Early stage breast cancer is when the tumour is confined to the breast area and has not spread beyond the lymph nodes to other parts of the body.
2. These data were provided to Cancer Research UK by the Office for National Statistics on request, July 2013. Further information can be found on the CRUK website: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/.
3. Early invasive breast cancer is defined as cancer that is confined to the breast and ipsilateral axillary lymph nodes. This is usually classified as stage I and II breast cancer.

Data on around 17,800 women diagnosed with breast cancer in the East of England in 2006-2009 shows that, of the 92% of cancers for which a stage was recorded, 41% were stage I, 45% stage II, 9% stage III and 5% stage IV. Source: Lyratzopoulos G, Abel GA, Barbiere JM, et al. Variation in advanced stage at diagnosis of lung and female breast cancer in an English region 2006-2009. Br J Cancer 2012. 106(6):1068-75: http://www.ncbi.nlm.nih.gov/pubmed/22382691.

For more information about the stages of breast cancer, please see: http://www.cancerresearchuk.org/cancer-help/type/breast-cancer/treatment/number-stages-of-breast-cancer.

4. The data and clinical outcomes to be entered into the national register include:

• histology of the cancer and patients’ characteristics (including type, size, side of tumour, grade, lymph node status, oestrogen receptor status, progesterone receptor status, human epidermal growth factor receptor 2 status and age of the patient)
• local recurrence
  • treatment received after local recurrence
  • development of metastatic disease
  • disease-free survival
  • overall survival
  • adverse effects of treatment
• health-related quality of life (including EQ-5D)

About the guidance

• The draft guidance for Intrabeam (IORT) for early breast cancer will be available from the NICE website at http://www.nice.org.uk/Guidance/InDevelopment/GID-TAG353 from Friday 25 July 2014. Embargoed copies of the draft guidance are available from the NICE press office on request.

• The Appraisal Committee concluded that the evidence did not conclusively show that intrabeam radiotherapy is as effective as conventional radiotherapy (called External Beam Radiotherapy - EBRT) at preventing local breast cancer recurrence (when the cancer returns to the same breast). However, the committee acknowledged that the recurrence rates reported in the clinical trial could be considered low in absolute terms. Based on the evidence available so far, it agreed that these were not out of line compared with current recurrence rates with EBRT in the NHS.
• The committee also acknowledged that for some people, the benefits of avoiding the need for post-surgical radiotherapy would outweigh the consideration that much less is known about the long term outcomes of Intrabeam treatment compared with conventional radiotherapy.
• The independent Appraisal Committee considered that it was not possible to declare a most plausible incremental cost-effectiveness ratio (ICER) for intrabeam compared with EBRT. This was because of a high degree of uncertainty in the cost-effectiveness analysis. However, the committee concluded that intrabeam was associated with slightly lower costs and fewer QALYs (Quality Adjusted Life Years) than EBRT.

The committee noted that there were also several benefits highlighted by the patient expert and clinical specialists in terms length of treatment and improving patients’ quality of life, which could not be captured in the QALY calculation.

• According to the manufacturer, the cost of an intrabeam radiotherapy machine is £435,000 (excluding VAT). The manufacturer estimated that device maintenance and servicing costs per year are in the region of £35,000.
• When published, this guidance will apply to England only.