APPENDICES - NIHR Health Technology Assessment Programme

Study details Population details Treatment details Results Interpretation
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37
Authors’ conclusions Photosan
seems to be more effective than ALA
in PDT of malignant tracheobronchial
stenosis. However, these results would
need confirming in a randomised,
blinded trial
Brief study appraisal This small
pilot study was non-randomised and
the groups had differences at baseline
which may have impacted on results.
The survival data do not solely
reflect the effectiveness of the PDT
treatment, as 4 wk after PDT patients
were eligible to receive a variety
of other treatments. There are also
doubts as to whether the ALA dosage
was optimal
Mortality The mean survival for
the ALA group was 9 mth and the
Photosan group 14 mth (p = 0.020)
Morbidity 4 wk FU
In the ALA group, stenosis diameter
dropped from a mean value of 79%
to 63%. In the Photosan group the
mean value dropped from 50% to 19%,
p = 0.00073, in favour of Photosan.
Dyspnoea was improved in 10/16 ALA
patients and 19/24 Photosan patients.
Haemoptysis subsided in 13/16 ALA
patients and 20/24 Photosan patients.
Radiological and clinical signs of
poststenotic pneumonia subsided in
5/9 ALA patients and 9/13 Photosan
patients. There was no statistically
significant difference between groups
on pulmonary function parameters
QoL and return to normal
activity Mean Karnofsky value
changed from 78 to 79 in the ALA
group, and from 70 to 78 in the
Photosan group, showing a significant
difference in favour of the Photosan
group (p = 0.00015). One patient had
an improvement of 10% in the ALA
group, whereas 11 patients in the
Photosan group improved by 10%
and five improved by 20%. None of
the patients in the Photosan group
reported a decrease in QoL due to
long-lasting need for skin protection
AEs No sunburn occurred in either
group. No major complications
relating to photosensitisation, PDT
or HBO were observed. Minor
complications were: fever in the
afternoon after PDT (12 in ALA group,
18 in Photosan group) and mild chest
pain for 1 or 2 d (6 in the ALA group
and 13 in the Photosan group). None
of the AEs required specific treatment
Trial treatments PDT with 5-ALA
and HBO vs PDT with Photosan and
HBO
Intervention ALA was orally
administered at a dose of 60 mg/kg,
6–8 hr prior to PDT
In cases of severe tumour stenosis,
PDT was carried out by using a fibre
with a 2-cm tip radial light-diffusing
cylinder, which was inserted through
the biopsy channel of the endoscope.
In cases of moderate tumour stenosis
a 2-cm balloon applicator system
was used for homogeneous light
distribution. During treatment the
radial light diffusing cylinder and/or
balloon applicator system was closely
applied to the surface of the tumour.
The light dose was 100 J/cm2 . Light
at 630 nm was applied by a KTP-Nd:
YAG laser with a DYE module. In
both groups additional hyperbaric
oxygenation at a level of 2 ATA in
a walk-in hyperbaric chamber was
undertaken. Oxygen was applied
using a Scuba valve system. Each
treatment was performed under
short-term intravenous anaesthesia
with endotracheal intubation
and spontaneous breathing. Skin
protection was managed by use of a
camouflage (Covermark, Milan, Italy)
for 24 hr after photosensitisation
Comparator Photosan-3 was
administered intravenously at a
dosage of 2 mg/kg, 48 hr prior to PDT.
See intervention for details of PDT
delivery. Skin protection was by using
a commercially available sun blocker
for 12 wk
Treatment intention Palliative
Type of Lung Cancer and
Histology Non-small cell
Main eligibility criteria Patients
with malignant tracheobronchial
stenosis, not eligible for resection
treatment because of poor
performance status, functional and/
or anatomical inoperability, and/or
refusing surgery
Patient characteristics
% Male: 75
Mean age: ALA, 64 yr; Photosan,
66 yr
Cancer stage: Stage IIb, seven; Stage
IIIa, 13; Stage IIIb, six; Stage IV, 14
Squamous cell 27, Adenocarcinoma
10, Large cell carcinoma three
Stenosis mean (range): ALA, 79%
(50–90%); Photosan, 50% (20–95%)
22 patients with radiological
and clinical signs of poststenotic
pneumonia
Karnofsky status mean (range):
ALA, 78 (60–90); Photosan, 70
(60–80)
Further patient characteristics
were reported
Concomitant treatment At
least 4 wk after combined PDT/
HBO, all patients were considered
for further treatment, including
high-dose rate brachyradiotherapy,
external beam irradiation and/or
chemotherapy
Authors Maier et al.
(2002) 127
Data source Full
published paper
Country Austria
Language English
Study design Non-
RCT
No. of participants
Total: 40
Intervention: 16
Comparator: 24
No. of Recruiting
Centres One
Follow-up period
and frequency 1 wk
and 4 wk
© 2010 Queen’s Printer and Controller of HMSO. All rights reserved.
ATA, atmosphere absolute.
271