APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
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DOI: 10.3310/hta14370 <strong>Health</strong> <strong>Technology</strong> <strong>Assessment</strong> 2010; Vol. 14: No. 37<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions A<br />
single course of verteporfin<br />
PDT showed treatment benefit<br />
for patients with multiple nonmelanoma<br />
skin cancers<br />
Brief study appraisal No<br />
clinically relevant comparator<br />
treatment was used, there<br />
was a lack of information on<br />
issues such as blinding and<br />
allocation concealment, and the<br />
authors did not present many<br />
results and population details<br />
by diagnosis. It is therefore<br />
difficult to make any reliable<br />
conclusions about the efficacy<br />
of verteporfin in patients with<br />
BCC<br />
Morbidity At 6 mth, the<br />
histopathological response (i.e. no<br />
residual tumour) was: nBCC: 76% at<br />
60 J/cm2 , 82% at 120 J/cm2 , and 100% at<br />
180 J/cm2 ; superficial BCC: 63%, 80%,<br />
and 97%; BCC not specified: 0%, 56%<br />
and 75%<br />
There was a trend indicating a better<br />
response with a higher light dose<br />
(p = 0.06)<br />
QoL and return to normal<br />
activity Reported by light dose<br />
rather than tumour type<br />
AEs Reported by light dose, rather<br />
than by tumour type<br />
Trial treatments PDT at 60 J/cm2 vs<br />
PDT at 120 J/cm2 vs PDT at 180 J/cm2 Intervention PDT at 60 J/cm2 : 10<br />
min intravenous infusion of 14 mg/m2 verteporfin, followed 1–3 hr later<br />
by exposure to 60 J/cm2 of red light<br />
(688 ± 10 nm) from a non-thermal<br />
LED panel. The exposed area included<br />
a margin of 3–4 mm around the<br />
lesion. The irradiance delivered was<br />
200 ± 40 mW/cm2 . Tumours re-treated<br />
at 3 mth if necessary (with dose<br />
increased to 18 mg/m2 )<br />
Comparator PDT at 120 J/cm2 : See<br />
above<br />
2nd comparator PDT at 180 J/cm2 :<br />
See above<br />
Treatment intention Curative<br />
Type(s) of cancer and<br />
histology Superficial BCC, 277<br />
lesions (66%); nBCC, 93 lesions<br />
(22%); Bowen’s disease, 34 lesions<br />
(8%); BCC unspecified 17 lesions<br />
(4%)<br />
Main eligibility criteria<br />
Patients with at least two biopsyproven<br />
superficial or nBCC or<br />
Bowen’s lesions<br />
Patient characteristics Not<br />
stated for BCC only (study also<br />
included SCC) but overall:<br />
Average tumours treated per<br />
patient = eight<br />
Age range: 22–79 yr<br />
Mean age: 55 yr<br />
Most patients had Fitzpatrick skin<br />
type II or III<br />
Concomitant treatment Oral<br />
analgesic drugs for pain<br />
Authors Lui et al. (2004) 68<br />
Data source Full published<br />
paper<br />
Countries Canada, USA<br />
Language English<br />
Study design RCT (betweenparticipant<br />
comparison)<br />
No. of participants<br />
Total: Not stated by diagnosis<br />
(387 lesions classified as BCC)<br />
Intervention: Superficial BCC<br />
120 lesions; nBCC 47 lesions;<br />
BCC (not specified) zero<br />
Comparator: Superficial BCC<br />
77 lesions; nBCC 30 lesions;<br />
BCC (not specified) nine<br />
2nd Comparator: Superficial<br />
BCC 80 lesions; nBCC 16<br />
lesions, BCC (not specified)<br />
eight<br />
No. of recruiting centres<br />
Four<br />
Follow-up period and<br />
frequency FU at 6 wk, and 3,<br />
6, 12, 18 and 24 mth (optional<br />
beyond 6 mth)<br />
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