The National Institute for Clinical Excellence is examining interstitial laser therapy for breast cancer 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 breast cancer.

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 recommendation
• 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• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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 Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 22 June 2004

Target date for publication of guidance: September 2004

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 breast cancer does not appear adequate to support the use of this procedure outside formal research. It is suitable for use only within good quality research studies approved by a research ethics committee and with explicit patient consent.

Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. The Institute may review the procedure upon publication of further evidence.

This procedure is used to treat breast cancer.

Standard treatments for small breast cancers include lumpectomy or mastectomy (without preceding laser therapy), and minimally invasive techniques such as radiofrequency ablation or cryotherapy.

Interstitial laser therapy is a minimally invasive technique for treating small breast cancers. After locating the tumour using stereotactic techniques or ultrasound, laser energy is delivered into the tumour via a needle probe. This causes the tumour to shrink. A surgeon may then remove the tumour, although sometimes surgery is not necessary.

The evidence was limited to small case series, and case study data. One study of interstitial laser therapy followed by surgery reported that 98% (43/44) of patients were disease-free at follow-up. However, follow-up ranged from 2 to 26 months, and it was difficult to determine whether the results were attributable to laser therapy or surgery. This study also found no histological sign of laser damage in the tumours of 9% (4/44) of patients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that it was still uncertain whether the procedure could achieve thermal ablation of all malignant tissue. They also noted that there were no data comparing outcomes of the procedure with those of wide excision and radiotherapy.

The following complications were reported in the identified studies: small skin burns 11% (4/35); necrosis of non-tumour tissue caused by incorrectly placed laser 10% (2/20); pain sufficient to stop treatment 7% (3/44); gaseous rupture of tumour 3% (1/35); and haemorrhage 2% (1/44). For more details, refer to the sources of evidence (see Appendix).

One Specialist Advisor considered that this procedure should not be used outside a clinical trial. Another Advisor listed the potential adverse effects of the procedure as necrosis, haemorrhage, and liquefaction caused by overheating of the tissue.

The Institute has published technology appraisals on the use of the following drugs for breast cancer: temozolomide, capecitabine, taxanes, trastuzumab and vinorelbine. For further information visit the NICE website at www.nice.org.uk.

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 breast cancer, March 2003

Available from: www.nice.org.uk/ip037overview