3 Committee discussion

Efficacy

3.1

There were no randomised controlled or comparative trials comparing the efficacy of PDT with other treatment modalities. There was considerable heterogeneity among the studies included in the systematic reviews, with regard to both 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.

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 overview.

3.3

The Specialist Advisors stated that there were no long-term comparative data on the efficacy of this procedure.

Safety

3.4

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.

3.5

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. Some effects may be due to pre-existing pulmonary disease rather than the procedure. 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 overview.

3.6

The Specialist Advisors listed photosensitivity as the main complication. Other potential adverse events were tissue necrosis leading to bleeding, and fistula formation.

Other comments

3.7

It was 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.

3.8

This procedure may be used in combination with other treatment modalities.

3.9

The heterogeneous groups of patients included in the studies and reviews made interpretation of the data difficult.

Sources of evidence

3.10

The evidence considered by the committee is in the overview.