APPENDICES - NIHR Health Technology Assessment Programme

258
Appendix 17
Study details Population details Treatment details Results Interpretation
Authors’ conclusions Combined
PDT/HBO represents a new
approach in the treatment of
oesophageal and cardial cancer
which appears to have enhanced the
efficiency of PDT
Brief study appraisal This
study was not randomised (and
so may have been subject to
bias) and included a fairly small
number of patients. The authors
did though acknowledge that
definitive conclusions could not be
drawn based on these results. This
publication appears to be the same
study as a report of a pilot study
211 , although the authors were not
Trial treatments PDT vs
PDT/HBO
Intervention PDT:
HpD given intravenously
(2 mg/kg) and camouflage
skin protection used for
2 wk, then sunblock for
10 wk. PDT given 48 hr
after sensitisation with
a fibre (1-cm tip, radial
light diffusing cylinder)
inserted through the biopsy
channel of the endoscope
(several placements were
necessary). Light dose was
300 J/cm, 630 nm applied
with a KTP-Nd:YAG laser
with DYE box. Treatment
given under short-term
anaesthesia. Endoscopy was
repeated 2–3 d after PDT
and necrotic tissue removed
mechanically if necessary.
Prior to PDT, dilatation and
retrograde Nd:YAG was
necessary in 15 cases
Comparator PDT/
HBO: As for PDT except
patients had ear, nose
and throat check-up, then
PDT given under HBO (2
atmospheres) in a walk-in
hyperbaric chamber
explicit about this
Mortality Median overall survival with PDT
was 7 mth (vs 12 mth in PDT/HBO group),
p = 0.0098. 12-mth survival with PDT was
25% vs 52% with PDT/HBO
Morbidity At 3 mth, stenosis decreased in
both groups by 6 mm
In the PDT group median tumour length
decrease was 2 cm vs 3 cm in the PDT/HBO
group, p = 0.0002
At 3-mth FU (or last FU in case of death)
in the PDT group dysphagia score could be
lowered by one level in eight cases (vs nine)
and two levels in 23 cases (vs 33) (and in
the PDT/HBO group it could be lowered by
three levels in two cases); this significantly
favoured PDT/HBO (p = 0.0064). No
recurrent dysphagia was observed at 3-mth
FU for either group
QoL and return to normal activity At
least a semi-solid diet was possible in all
patients after either treatment
AEs There were no major postinterventional
complications or skin photosensitisation
related to either treatment. No barotrauma
was observed. Minor complications included:
odynophagia (PDT group 6 vs PDT/HBO
8); fever up to 39° in the afternoon of the
interventional day, one in PDT vs three in
PDT/HBO); chest pain for 1 or 2 d (four in
PDT vs seven in PDT/HBO). 30-day mortality
was 0%. Six oesophagotracheal fistulas in two
patients were found (PDT, two cases; PDT/
HBO four cases)
Resource use Hospitalisation in both
groups was 3–9 d (median 4.9 d)
Treatment intention Not
stated
Type(s) of cancer and
histology Advanced
oesophageal carcinoma
Main eligibility criteria
Patients that were not eligible
for resection treatment due to
significant comorbidity were
included
Patient characteristics
% Male: 80
Mean age: PDT alone, 67 yr;
PDT/HBO 67.5
Age range: 46–87 yr Cancer
stage: III, 59; IV, 16 Dysphagia
score: level 2, 23; level 3,
37; level 4, 15. 40 SCC, 35
adenocarcinoma
Further patient characteristics
were reported
Concomitant treatment
Not stated
Authors Maier et al.
(2000) 116
Linked publications211 Data source Full published
paper
Country Austria
Language English
Study design Non-RCT
No. of participants
Total: 75
Intervention: 31
Comparator: 44
No. of recruiting centres
One
Follow-up period and
frequency FU after 1 mth,
then every 3 mth