APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
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246<br />
Appendix 16<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions The preliminary data suggest that<br />
ALA–PDT is both safer and potentially more effective than<br />
PDT with Photofrin but FU is short and not all patients in the<br />
trial have been treated as yet<br />
Brief study appraisal This trial was reported in abstract<br />
form only so full details of the methods are not available. The<br />
data presented are promising but would need confirmation in<br />
longer FU and with all the planned patients treated<br />
Mortality Not assessed<br />
Morbidity Five patients are<br />
undergoing repeat therapy (three<br />
Photofrin, two ALA). Remission rates<br />
are 14 of 14 (100%) in the ALA–PDT<br />
group and nine of 14 (64%) in the<br />
Photofrin group (p < 0.05)<br />
AEs Strictures developed in six of 16<br />
patients treated with Photofrin and<br />
one of 16 treated with ALA (probably<br />
not related to treatment), p < 0.05.<br />
Skin photosensitivity developed in<br />
seven of 16 patients treated with<br />
Photofrin, one of whom had to be<br />
briefly admitted to hospital. No<br />
instances of photosensitisation were<br />
found with ALA (p < 0.05). There<br />
were no other significant differences<br />
between groups regarding side effects<br />
Resource use Not assessed<br />
Trial treatments ALA–<br />
PDT vs PDT with Photofrin<br />
Intervention 60 mg/kg ALA<br />
activated by 1178 J/cm of red<br />
laser light<br />
Comparator Photofrin<br />
PDT with the standard<br />
protocol or as previously<br />
shown to be the most<br />
effective (no further details<br />
given)<br />
Treatment<br />
intention Not<br />
stated<br />
Type(s) of cancer<br />
and histology BO<br />
with HGD<br />
Main eligibility<br />
criteria Patients<br />
with BO with<br />
HGD confirmed by<br />
two independent<br />
pathologists were<br />
eligible for the trial.<br />
Any visible nodules of<br />
HGD were removed<br />
and patients only<br />
treated if residual<br />
HGD was still<br />
present<br />
Patient<br />
characteristics Not<br />
stated<br />
Concomitant<br />
treatment Not<br />
stated<br />
Authors Mackenzie<br />
et al. (2008) 104<br />
Data source<br />
Abstract<br />
Country UK<br />
Language English<br />
Study design RCT<br />
No. of participants<br />
Total: 40 recruited<br />
of a planned 66. 32<br />
were treated<br />
Intervention: ALA–<br />
PDT: 16<br />
Comparator: PDT<br />
with Photofrin: 16<br />
No. of recruiting<br />
centres Not stated<br />
Follow-up period<br />
and frequency<br />
6 wk, 4 mth and 1 yr<br />
post therapy
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