The National Institute for Clinical Excellence is examining photodynamic therapy for bronchial carcinoma 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 photodynamic therapy for bronchial carcinoma.

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• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 27 April 2004

Target date for publication of guidance: July 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 photodynamic therapy for bronchial carcinoma appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

This procedure is used to treat patients with inoperable non-small cell lung cancer, which has a poor prognosis.

Alternative treatments include debulking with biopsy forceps, radiotherapy, and laser resection.

Photodynamic therapy (PDT) of bronchial carcinoma is a minimally invasive treatment, involving intravenous injection of a photosensitising agent, followed a few days later by photoradiation of the affected area through a bronchoscope. This is intended to reduce the bulk of the tumour, thereby reducing symptoms caused by bronchial obstruction.

Three small randomised controlled trials (RCTs) were identified, in addition to non-randomised comparative studies and case series. The two largest randomised studies compared PDT with laser treatment; both studies reported that symptomatic improvement was similar for both treatments. One of these studies reported a mean increase in forced vital capacity of 0.47 litres in the PDT group, compared to a mean decrease of 0.06 litres in the laser group; and a mean increase in forced expiratory volume in 1 second of 0.35 litres for the PDT group, compared to 0.01 litres for the laser group. The other study reported median time to treatment failure to be 50 days for the PDT group and 38 days for the laser group, and average survival to be 265 days for the PDT group compared to 95 days for the laser group. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that it was not clear whether tumour bulk reduction in a palliative setting was associated with gains in quality of life or survival. They also noted that careful patient selection is needed.

The largest RCT reported at least one adverse effect in 100% (14/14) of patients in the PDT group and 71% (12/17) of patients in the laser group. In this study the most common adverse effects in the PDT group were bronchitis 29% (4/14); photosensitisation 29% (4/14); dyspnoea 21% (3/14); and death (probably related to treatment) 7% (1/14). For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors generally considered this procedure to be safe. They listed the main potential adverse events as skin photosensitivity, bleeding, necrosis/obstruction, late strictures, oesophago-bronchial fistula formation, and airway occlusion by exudates.

The evidence for this procedure is based on small but good quality RCTs. Further research or audits would be useful.

It was noted that the role of this procedure in conjunction with other techniques is uncertain.

The Institute has issued guidance on chemotherapy drugs for lung cancer, and is currently developing a guideline for the diagnosis and treatment of lung cancer. 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 photodynamic therapy for bronchial carcinoma, March 2003

Available from: www.nice.org.uk/ip100overview