APPENDICES - NIHR Health Technology Assessment Programme

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Appendix 15
Study details Population details Treatment details Results Interpretation
Authors’ conclusions There is a
significant increase in the CR rate of
PDT using two-light fraction illumination
scheme compared with a singleillumination
scheme
Brief study appraisal Although
treatment methods were very well
described, study design details on issues
such as randomisation, blinding, and
dropouts (were 154 or 155 patients
treated?) were not provided, making it
difficult to assess the reliability of the
results
Morbidity CR of lesions
was significantly greater using
fractionated illumination compared
with single illumination (at 1 yr,
97% vs 89%, p = 0.002). The results
were very similar when analysis
was undertaken on a subgroup of
histologically proven BCCs. 10/262
(4%) lesions failed to respond,
or recurred, in the fractionatedillumination
group compared
with 32/243 (13%) in the singleillumination
group (p = 0.0002).
There were no significant
differences in response rates, within
each illumination group, for the
different light sources used
QoL and return to normal
activity Assessed but not reported
AEs 5/100 (5%) patients required
pain relief in the single illumination
group compared to 15/55 (27%)
patients in the fractionated
illumination group
Trial treatments Fractionated illumination
PDT vs single-illumination PDT
Intervention Fractionated illumination
PDT: Crusts and scaling were gently removed
using a disposable curette before ALA
application. Illumination using doses of 20 and
80 J/cm2 (at 50 mW/cm2 ) delivered 4 and 6 hr
after administration of 20% ALA ointment
(containing 2% lidocaine) with a 1-cm margin.
One of three different light sources were
used on each lesion (a 630-nm diode laser,
coupled into a 600-µm optical fibre and using a
combination of lenses for uniform fluence rate;
a light-emitting diode 633 nm with a bandwidth
of 20 nm; or a 2nd broadband source with
an output of between 590 and 650 nm), with
a margin of at least 5 mm. A light-protective
bandage (including aluminium foil) was used
to provide the 2-hr dark interval between
fractions. Participants were instructed to stay
out of the cold
Comparator PDT with placebo cream:
Patients received two cycles (1 wk apart)
of placebo cream PDT. There was surface
debridement and slight lesion debulking prior
to PDT. BCC with partial clinical response at
3 mth were re-treated. Further parameters
were not reported
Treatment
intention Curative
Type(s) of cancer
and histology
Primary superficial
BCC
Main eligibility
criteria Not stated
Patient
characteristics Age
range: 31–83 yr
Mean age: 57 yr
All participants were
Caucasians
Concomitant
treatment
Paracetamol, lidocaine
(without adrenaline)
or bupivacaine if
required
Authors de Haas et al.
(2006) 83
Data source Full
published paper
Country The
Netherlands
Language English
Study design RCT
(between-participant
comparison)
No. of participants
Total: 154 (505 lesions)
Intervention: 55 (262
lesions)
Comparator: 100 (243
lesions)
No. of recruiting
centres One
Follow-up period and
frequency FU four times
a year in 1st year, then
twice yearly. Patients
tending to develop more
lesions were seen more
frequently. Minimum FU
period was 1 yr, maximum
FU period was 5 yr