APPENDICES - NIHR Health Technology Assessment Programme

DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37
Study details Population details Treatment details Results Interpretation
Authors’ conclusions PDT for treating AK
has a similar response rate to cryotherapy,
but with superior cosmetic results and high
patient satisfaction
Brief study appraisal In relation to CR,
the authors’ conclusions appeared only to
relate to thin facial lesions, with uncertainty
surrounding other results (which frequently
lacked p-values). Cosmetic outcome and
satisfaction results were based on smaller
patient numbers. The study was not blinded
which coupled with the real possibility
of institutional differences and protocol
deviation (13 centres in five countries) casts
further doubt on the reliability of the results
Morbidity The overall CR rate
was 69% (252/367) for PDT vs 75%
(250/332) for cryotherapy. Higher
response rates were observed in grade
I (thin) lesions than in thicker lesions.
Grade I facial lesions showed the best
response regardless of intervention arm
QoL and return to normal activity
Cosmetic outcome was significantly
better in PDT group (p = 0.035), where
96% of investigators and 98% of patients
graded outcome as excellent or good
(vs 81% and 91%, respectively, for
cryotherapy group). In the PDT group,
of the 43 previously treated patients
(various treatments such as cryotherapy
and 5-FU) 32 rated PDT as better, 10 as
equal, and one worse than the previous
treatment
AEs Local AEs were reported by 44
(43%) of PDT patients vs 26 (26%) of
cryotherapy patients. The commonest
were burning sensation (PDT 32% vs
cryotherapy 9%), skin pain (10% vs
13%) and crusting (5% vs 6%). Three
patients stopped treatment due to local
reactions – one PDT (burning) and two
cryotherapy (pain)
Trial treatments MAL–PDT vs
Cryotherapy
Intervention MAL–PDT: Loose
crusts were removed using a
curette and the surface gently
roughened. MAL cream (160 mg/g)
was applied as a 1-mm-thick layer
and to 5 mm of surrounding normal
tissue. The area was covered with
an occlusive dressing for 3 hr, after
which the cream was washed off
with a saline solution, followed by
illumination with non-coherent
red light (570–670 nm) with a total
light dose of 75 J/cm2 and a light
intensity of 70–200 mW/cm2 . The
mean illumination time was 11 min.
Up to 10 lesions were treated at
the same session. The procedure
was repeated after 1 wk in lesions
not on the face or scalp (8% of
patients)
Comparator Cryotherapy:
preparation with superficial
curettage, followed by cryotherapy
with liquid nitrogen spray to
achieve a 1- to 2-mm frozen rim
outside the marked lesion outline.
The mean total freezing time was
24 s. The freezing procedure was
performed in two cycles during the
single treatment session
Treatment intention
Curative
Type(s) of lesion and
histology AK
Main eligibility criteria
Patients > 18 yr old, with up
to 10 AK lesions suitable for
cryotherapy and no treatment
within the last 4 wk when
eligible. Diagnosis was based
on clinical assessment (and
histology where needed).
Patients receiving regular
UV therapy and patients
with pigmented lesions or
porphyria were excluded
Patient characteristics
% Male: 61
Age range: 42–89 yr
Mean age: 71 yr (PDT), 72 yr
(cryotherapy)
58% of patients had 1–3
lesions, 33% had 4–7 lesions,
and 9% had 8–10 lesions.
Lesions were mostly of thin
(40%) or moderate (52%)
grade, and most were located
on the face (63%) or scalp
(28%)
Concomitant treatment
Not stated
Authors Szeimies et
al. (2002) 51
Linked
publications174,175 Data source Full
published paper
Countries Austria,
Germany, Italy,
Switzerland, the
Netherlands
Language English
Study design RCT
No. of participants
Total: 202 (732
lesions)
Intervention: 102
(384 lesions)
Comparator: 100
(348 lesions)
No. of recruiting
centres 13
Follow-up period
and frequency At
2 wk and 3 mth
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