The National Institute for Clinical Excellence is examining interstitial laser therapy for fibroadenomas of the breast and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about interstitial laser therapy for fibroadenomas of the breast.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows:

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 22 March 2005

Target date for publication of guidance: June 2005

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of interstitial laser therapy for fibroadenomas of the breast does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake interstitial laser therapy for fibroadenomas of the breast should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Audit and review all patients having interstitial laser therapy for fibroadenomas of the breast.
• Ensure that patients understand the benign nature of fibroadenomas, and that watchful waiting is an option. Patients should be provided with clear written information and use of the Institute's Information for the public is recommended.
  

A fibroadenoma is a benign (non-cancerous) solid lump of breast tissue, which is thought to result from increased sensitivity to oestrogen. Fibroadenomas are very common and it is not unusual to have more than one. They are mostly found in young women but can occur in women of any age.

Most fibroadenomas do not enlarge after diagnosis. Some get smaller and some eventually disappear over time. These provisional recommendations relate to options for breast fibroadenomas that do not resolve.

High-energy light delivered via a laser fibre is used to destroy the fibroadenoma. The fibre is positioned through a needle inserted percutaneously under local anaesthesia. The tip of the needle is positioned at the centre of the lump under ultrasound guidance. A pre-sterilised bare fibre is then passed through the needle a short distance beyond the tip, and the laser energy is delivered through this fibre. The energy is delivered in continuous wave mode for a few minutes. For larger lumps, multiple needles are inserted 1 cm apart, with a laser fibre through each.

In a case series of 24 patients, interstitial laser therapy reduced fibroadenoma size (as assessed by ultrasound measurement) from a mean length of 25 mm at baseline to 14 mm at 3 months, 10 mm at 6 months, and 0 mm at 12 months. There were no palpable fibroadenomas in the 14 women followed-up for 12 months.

The Specialist Advisors noted that the lack of material for biopsy with this procedure (in contrast to surgical excision) means that the benign diagnosis cannot be confirmed.

In a case series of 24 women who had undergone interstitial laser therapy, 83% (20/24) reported some discomfort during the procedure. Severe pain in 17% (4/24) of women led to the treatment being stopped prematurely. In this case series and another that involved 27 women, all the women complained of local tenderness that lasted from 1 to 8 weeks.

In one of the case series, 30% (8/27) of women had skin blanching at the needle site after 80-100 seconds of the treatment, and these women later developed epithelial breakdown and hyperpigmentation in the same area (follow-up 8 weeks). In the second case series, 17% (4/24) of women had bruising that resolved within 1 week.

The Committee noted that there are variations in technique that have potentially different efficacy profiles.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of interstitial laser therapy for fibroadenomas of the breast, December 2004

Available from: www.nice.org.uk/ip275overview