Palliative photodynamic therapy for advanced oesophageal cancer (interventional procedures consultation document

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Palliative photodynamic therapy for advanced oesophageal cancer

Oesophageal cancer usually arises in the lining of the gullet and, when advanced, causes difficulty in swallowing. Photodynamic therapy involves two steps: a medicine that has an affinity for cancerous cells and is sensitive to a particular type of light is administered; an appropriate light source (often a laser) is then inserted into the gullet to activate the photosensitive medicine, which destroys the cancer cells.


The National Institute for Health and Clinical Excellence is examining palliative photodynamic therapy for advanced oesophageal 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 palliative photodynamic therapy for advanced oesophageal 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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 22 August 2006
Target date for publication of guidance: December 2006


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 palliative photodynamic therapy (PDT) for advanced oesophageal cancer is of poor quality but appears adequate to support the use of this procedure to relieve the symptoms of patients with a poor prognosis. Clinicians wishing to use this procedure should ensure that normal arrangements are in place for consent, audit and clinical governance.
 
1.2 Palliative PDT for advanced oesophageal cancer should only be performed in specialist centres with regular experience in the surgery of oesophageal cancer.
 

 

2 The procedure
 
2.1 Indications
 
2.1.1 Oesophageal cancer is a common cancer that is increasing in incidence. The most common histological types are squamous cell carcinoma and adenocarcinoma. Oesophageal cancer may cause difficulty in swallowing (dysphagia), weight loss, hoarseness, chronic cough and chest pain. The depth of penetration of the tumour determines the stage of the cancer; tumours that extend beyond the submucosa, or that have spread to other organs, are in advanced stage. The treatment objective for such tumours is relief of symptoms, particularly dysphagia, and maintenance of good quality of life.
2.1.2 PDT is one of a range of palliative treatment options for advanced oesophageal cancer, which includes external-beam radiation, chemotherapy and the following endoscopically administered interventions: tube or stent placement, electrocautery, plasma/laser coagulation and brachytherapy.
 
 
 
2.2 Outline of the procedure
 
2.2.1 PDT involves the administration of a photosensitising agent by intravenous injection. The photosensitising agent is then activated by exposing the tumour to light, usually with a low-power laser introduced through an endoscope. The agent absorbs energy from the light (a photochemical effect), forming high-energy oxygen molecules that destroy tumour cells. A number of different photosensitising agents have been used in PDT for oesophageal cancer. Treatment can be performed on an outpatient basis and is usually done under intravenous sedation.
 
 
 
2.3 Efficacy
 
2.3.1 Most studies described patients as having advanced oesophageal cancer, although the definitions used were not always well described.
 
2.3.2 In a randomised controlled trial, the response rate was significantly higher after PDT (32%) than after laser ablation (20%) (p < 0.05). In the same study, the complete local response rate (defined as absence of the tumour at endoscopy) at 1-month follow-up was 8% (9/110) in the PDT-treated group and 2% (2/108) in the laser-ablation group. In several case series, the complete response rate varied between 0% (0/14) and 7% (6/84) at 6-8 weeks' follow-up.
2.3.3 A randomised controlled trial comparing PDT with laser ablation found that there was no statistically significant difference in improvement of dysphagia between the treatments. One case series of 215 patients (85% of whom were available for evaluation) showed that PDT reduced dysphagia, measured on a 5-point scale, from a median score of 3 points at baseline to 2 points at follow-up (p < 0.0001). A second case series showed an improvement in mean dysphagia score on the same scale from 4.0 points at baseline to 2.8 points following PDT. A third case series found that 5% (4/84) of patients had dysphagia to semi-liquid diet (purée) at 6-8 weeks after PDT; all other patients had milder symptoms. A fourth case series reported that PDT produced a statistically significant improvement in the minimum oesophageal diameter from 6.2 mm to 11.1 mm (p < 0.0001).
2.3.4 Mean survival following PDT was reported in four studies as 4.8 months, 9.5 months, 9.7 months and 13.9 months. Where survival by stage was reported separately, mean survival varied from 12 months for patients with stage II cancer to 3.5 months for patients with stage IV cancer. For more details, refer to the sources of evidence (see appendix).
2.3.5 The Specialist Advisers were divided in their opinions as to whether this procedure is established practice or novel and of uncertain safety and efficacy.
 
 
2.4 Safety
 
2.4.1 The most common complication relating to PDT in one case series was skin photosensitivity, which occurred after 6% (19/318) of treatments; second-degree sunburn was reported in one of 215 patients (<1%). Another case series of 128 patients reported no serious reactions resulting from exposure to sunlight.
2.4.2 A randomised controlled trial reported that the incidence of oesophageal perforation was significantly lower with PDT (1%) than with laser ablation (7%) (p < 0.05). The rate of oesophageal perforation reported in one study was 2% (5/215), and in a second case series of 128 patients there were two cases (2%) each of fistula of the trachea and fistula of the left main bronchus. Stricture following PDT was reported in 2% (5/215), 3% (4/128) and 7% (6/84) of patients. In some cases the stricture required dilatation. For more details, refer to the sources of evidence (see appendix).
2.4.3 The Specialist Advisers stated that adverse events may include photosensitisation, perforation of the oesophagus or left main bronchus, worsening oesophageal motility, stricture, herpes zoster, nausea, erythema, pain, fever, pleural effusion, respiratory complications and abscess at the treatment site.
 
 
 

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
August 2006

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 palliative photodynamic therapy for advanced oesophageal cancer', May 2006.

Available from: www.nice.org.uk/ip340overview

This page was last updated: 16 June 2014