Interventional Procedures Consultation Document - Photodynamic therapy in early inoperable endobronchial cancer

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Photodynamic therapy for localised inoperable endobronchial cancer

The National Institute for Health and Clinical Excellence is examining photodynamic therapy for localised inoperable endobronchial 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 photodynamic therapy for localised inoperable endobronchial 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 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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 21 June 2005
Target date for publication of guidance: September 2005


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


1 Provisional recommendations
1.1

Current evidence on the safety and efficacy of photodynamic therapy for localised inoperable endobronchial cancer appears adequate to support the use of this procedure provided that the normal arrangements are in place for audit and clinical governance.

1.2 This procedure may be offered to patients with localised endobronchial cancer that is unsuitable for surgical resection. Clinicians should ensure that patients understand the aim of the treatment, especially when its purpose is palliation. Patients should also be informed of the alternative treatment options available. Clinicians should provide them with clear written information and, in addition, use of the Institute's Information for the public is recommended.
1.3 Further research and audit will be useful in clarifying the indications and benefits of this procedure.


2 The procedure
2.1 Indications
2.1.1

Localised endobronchial (non-small cell) lung cancer describes disease in which malignancy is confined within the bronchial wall, with no radiographic or endoscopic evidence of lymph node involvement. Patients for whom surgical resection may be considered unsuitable include those with bilateral lung cancer, previous resection for lung cancer, impaired respiratory function because of chronic obstructive pulmonary disease, other conditions posing high operative risk, or those who refuse surgery.

2.1.2 The range of treatment options for lung cancer depends on the type and stage of the disease and the suitability of major surgery for the individual patient. Treatment options include laser ablation, endobronchial brachytherapy and external beam radiation.
2.2 Outline of the procedure
2.2.1 Photodynamic therapy (PDT) involves injection of a photosensitising agent, followed a few days later by photoradiation to the affected area through a bronchoscope. This aims to reduce tumour bulk, so reducing symptoms caused by bronchial obstruction. Endobronchial debridement of necrotic tumour is required, commonly 48 hours after each treatment. The procedure can be repeated if necessary.
2.3 Efficacy
2.3.1

There were no randomised controlled or comparative trials comparing the efficacy of PDT to other treatment modalities. There was considerable heterogeneity among the studies included in the systematic reviews, both with regard to outcome measurements used and follow-up times reported. The complete remission rates following PDT ranged from 62% (16/26) to 85% (50/59) of lesions in different case series. Some subgroup analyses suggested that small lesions (in terms of diameter or surface area) respond to PDT better than larger lesions.

2.3.2

Where reported in case series, 5-year survival ranged from 43% among 36 patients with poor pulmonary or cardiac function to 72% among 21 patients who were surgical candidates. Other studies reported reduction of airway obstruction and improvement in self-reported quality of life after PDT. For more details, refer to the sources of evidence (see Appendix).

2.3.3 Specialist Advisors stated that there were no long-term comparative data on the efficacy of this procedure.
2.4 Safety
2.4.1

In one systematic review, eight studies reported adverse events. Mild to moderate symptoms of photosensitivity were reported in all studies. Very severe toxicity resulting from photosensitivity occurred in a minority of patients undergoing PDT.

2.4.2 Fatal haemoptysis within 1 month of treatment was recorded in 8% (3/38) of patients in one case series. Hypercapnic respiratory failure (requiring mechanical ventilation) occurred in 5% (2/38) and 4% (1/24) of patients following PDT. Other case series reported mild to moderate pulmonary events including short-term productive cough following PDT (the proportion of patients was not reported). For more details, refer to the sources of evidence (see Appendix).
2.4.3 Specialist Advisors listed photosensitivity as the main complication. Other potential adverse events were tissue necrosis leading to bleeding and fistula formation.
2.5 Other comments
2.5.1 The Committee noted that a variety of laser systems is available and different dosage schedules may be used. These variations may have an effect on safety and efficacy.
2.5.2 The Committee noted that this procedure may be used in combination with other treatment modalities.
2.5.3 The heterogeneous groups of patients included in the studies and reviews made interpretation of the data difficult.
3 Further information
3.1 The Institute has issued guidance on the diagnosis and treatment of lung cancer (www.nice.org.uk/CG024). The Institute has also issued interventional procedures guidance on the use of photodynamic therapy for advanced bronchial cancer (www.nice.org.uk/IPG087guidance) and is developing guidance on cryosurgery for malignant endobronchial obstruction (www.nice.org.uk/ip_285).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
June 2005

Appendix: Sources of evidence

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 localised inoperable endobronchial cancer, November 2004

Available from: www.nice.org.uk/ip270overview

This page was last updated: 30 March 2010