The National Institute for Health and Clinical Excellence is examining photodynamic therapy for photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions). It 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 non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions).

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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 November
Target date for publication of guidance: February 2006

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

Current evidence suggests that there are no major safety concerns associated with photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions).

Evidence is limited on the efficacy of this procedure for the treatment of invasive squamous cell carcinoma. Recurrence rates are high and there is a risk of metastasis. Clinicians should ensure that patients understand these risks and that retreatment may be necessary. In addition, use of the Institute's Information for the public is recommended.

Current treatments for basal cell carcinoma include topical chemotherapy, curettage, surgical excision, cryotherapy and radiotherapy. Squamous cell carcinoma is usually removed surgically. Bowen's disease and actinic keratoses are usually treated with curettage, cryotherapy or topical chemotherapy.

In photodynamic therapy (PDT), the lesion is prepared by removing overlying crust and scale. A photosensitising agent is applied to the lesion and a margin of surrounding skin. The lesion is illuminated by light of an appropriate wavelength to activate the photosensitiser, producing targeted tumour destruction. Occasionally, the photosensitising agent may be given intravenously. More than one lesion may be treated in a session and the treatment can be repeated.

One randomised controlled trial (RCT) of patients with basal cell carcinoma reported that there was no statistically significant difference in lesion clearance between PDT and surgery (91% [48/53] and 98% [51/52] of patients respectively). Another RCT reported that 25% (11/44) of patients had a positive biopsy at 12 months after PDT compared with 15% (6/39) of patients after cryotherapy (p > 0.05). Both of these studies reported statistically significantly better cosmetic outcomes after PDT than after the comparator.

The Specialist Advisors stated that there were some concerns about recurrence rates and that the treatment may be more appropriate for large, superficial lesions of Bowen's disease, actinic keratosis and basal cell carcinoma, especially where there are multiple lesions and where repair would otherwise require extensive surgery.

Adverse events were mainly transient local reactions. Three studies reported that the total rate of adverse events ranged from 43% (44/102) to 90% (38/42) of patients. The most common complication was a burning sensation of the skin, and this affected between 31% (16/52) and 64% (27/42) of patients. Two studies reported ulceration rates of 0% (0/20) and 12% (5/42) respectively. One large case series reported minor pigmentary changes and superficial scarring each in 2% (10/483) of lesions. Other adverse events included pain, erythema, crusting, itching, oedema and blisters. For more details refer to the Sources of evidence (see Appendix).

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 non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions), April 2005

Available from: www.nice.org.uk/ip272overview