APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
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260<br />
Appendix 17<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions Despite the limitations<br />
of a non-randomised study, photosensitisation<br />
with Photosan seems to be more effective<br />
in PDT of advanced oesophageal carcinoma<br />
compared with ALA<br />
Brief study appraisal The conclusions that<br />
could be drawn were limited as this was a small,<br />
non-randomised study. Baseline characteristics<br />
were largely similar apart from M stage and the<br />
authors’ cautious conclusions appear reliable.<br />
This study appears to have been published twice<br />
(see ref. 120) with Photosan being described<br />
as HpD. The patients, treatments and results<br />
appear to be identical, therefore only one study<br />
has been data extracted<br />
Mortality Median survival for<br />
ALA group was 8 mth vs 9mth,<br />
p = 0.44 (Kaplan–Meier survival<br />
curve in paper)<br />
Morbidity At 1 mth, there was<br />
significantly more improvement<br />
in the ALA group than the<br />
Photosan group for the following<br />
outcomes: dysphagia (p = 0.02),<br />
tumour stenosis (p = 0.00000)<br />
and tumour length (p = 0.000014)<br />
QoL and return to normal<br />
activity Karnovsky Performance<br />
status improved by 23% for<br />
ALA vs 44% for Photosan, not<br />
significant (p = 0.12)<br />
AEs No barotrauma of<br />
the ear was observed. No<br />
sunburn occurred in either<br />
group. There were no major<br />
AEs. 30-day mortality was 0%.<br />
Minor complications were:<br />
postinterventional odynophagia<br />
(nine in ALA group vs 13); fever<br />
up to 39° in the afternoon of the<br />
interventional day (five vs eight);<br />
chest pain for 1 or 2 d (nine vs<br />
13). After ALA administration all<br />
patients experienced nausea<br />
Resource use Hospitalisation<br />
was 4–6 d in both treatment<br />
groups<br />
Trial treatments ALA- PDT vs PDT with<br />
Photosan (HpD). Both performed with<br />
additional hyperbaric oxygenation<br />
Intervention ALA–PDT: Diagnostic<br />
work-up was performed using barium<br />
oesophagogram, oesophagogastroscopy,<br />
bronchoscopy and CT scans. Oral<br />
administration of ALA (60 mg/kg) then skin<br />
protection by camouflage for 24 hr. 6–8 hr<br />
after ALA, PDT was carried out using a fibre<br />
with 2-cm tip radial light-diffusing cylinder,<br />
inserted through the biopsy channel of the<br />
endoscope. Light dose was 300 J/cm fibre<br />
and 630-nm light was applied by KTP-Nd:<br />
YAG laser having a DYE module. Additional<br />
hyperbaric oxygenation was applied<br />
(after an ear, nose and throat check-up)<br />
at level 2 ATA using a Scuba valve system.<br />
Treatment was performed under short-term<br />
intravenous anaesthesia. Endoscopy was<br />
performed 2–3 d after PDT and necrotic<br />
tissue removed. Endoscopy was then<br />
performed after 1 mth, then every 3 mth.<br />
Increased tumour length and dysphagia at<br />
FU indicated further PDT treatment. No<br />
treatment was repeated within 3 mth after<br />
the 1st PDT session<br />
Comparator Photosan-PDT: As for ALA–<br />
PDT except intravenous administration of<br />
Photosan (2 mg/kg), 48 hr before PDT<br />
Treatment intention<br />
Palliative<br />
Type(s) of cancer and<br />
histology Advanced<br />
oesophageal cancer<br />
Main eligibility<br />
criteria Patients that<br />
were not eligible for<br />
resection treatment due<br />
to poor performance<br />
status, functional and/or<br />
anatomical inoperability,<br />
and/or refusing surgery<br />
were included<br />
Patient characteristics<br />
% Male: 78<br />
Age range: 46–88 yr<br />
Mean age: ALA, 69 yr;<br />
Photosan 68 yr<br />
Cancer stage: III, 17; IV<br />
32. Dysphagia score<br />
varied with most in level<br />
2 or 3 but no significant<br />
differences<br />
Overall there were 13<br />
SCC, 14 adenocarcinoma<br />
Further patient<br />
characteristics were<br />
reported<br />
Concomitant<br />
treatment Not stated<br />
Authors Maier et<br />
al. (2001) 118<br />
Linked<br />
publications120 Data source Full<br />
published paper<br />
Country Austria<br />
Language English<br />
Study design<br />
Non-RCT<br />
No. of<br />
participants<br />
Total: 49<br />
Intervention: 22<br />
(ALA–PDT)<br />
Comparator: 27<br />
(Photosan-PDT)<br />
No. of recruiting<br />
centres Not<br />
stated<br />
Follow-up period<br />
and frequency FU<br />
at 1 mth, then every<br />
3 mth<br />
ATA, atmosphere absolute.