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 is at least as effective
as cryotherapy in the
treatment of Bowen’s
disease and was associated
in this study with fewer AEs
and a lower recurrence rate
Brief study appraisal
This was a small trial using
a prototype lamp as a
light source. Results were
reported by lesion rather
than by patient. By chance
lesions were significantly
larger in the PDT group but
this was taken into account
when assessing clearance
rates. The results of the trial
are promising but would
require confirmation in
larger trials
Morbidity
Clearance after one treatment: PDT, 15 of 20
lesions; cryotherapy, 10 of 20 lesions
Clearance after two treatments: PDT, five
remaining lesions; cryotherapy, six lesions
The remaining four lesions in the cryotherapy
group required a third treatment. There was
no significant difference between the two
treatments in clearance rates. However, by
chance lesions treated by PDT were overall
larger than those in the cryotherapy group. In
a linear regression model taking size of lesion
into account, the probability that a lesion of any
size is completely cleared at the 1st treatment
was significantly greater with PDT than with
cryotherapy (p < 0.01). Recurrence Rate during
12-mth following clinical clearance: PDT zero;
cryotherapy two (6 mth and 8 mth). CR rate
was, therefore, 100% for PDT and 90% for
cryotherapy
QoL and return to normal activity Visible
scarring 12 mth following clearance (no. of
lesions): PDT zero, cryotherapy four
AEs Pain during treatment (no. of lesions): PDT,
six mild and five moderate; cryotherapy, 12 mild
and seven moderate (p = 0.01). Free from pain
10 d following treatment (no. of lesions): PDT
15; cryotherapy 10
All six patients who received both treatments,
due to having multiple lesions, reported PDT as
less painful. Blistering (no. of lesions): PDT zero;
cryotherapy seven. Ulceration (no. of lesions):
PDT zero; cryotherapy five. Secondary infection
(no. of lesions): PDT zero; cryotherapy two. No
photosensitivity reactions occurred after PDT
Trial treatments PDT with ALA vs Cryotherapy
Intervention PDT: Surface crusts were
removed and the surface gently abraded prior
to application with topical 5-ALA in an oil-inwater
emulsion 20%. Approximately 50 mg/cm2 of
cream was applied to cover the entire irradiation
field including the clinically disease-free margin.
The cream was kept in place under an occlusive
dressing
Four hours later lesions were illuminated with a
prototype lamp. The lamp incorporated a 300 W
xenon short arc plasma discharge producing a
continuous wave broadband flat spectral output
across the entire visible spectrum. Using filters,
the spectral output of the lamp was adjusted to
a 30-nm bandwidth, about 630 nm. To broaden
the treatment field and to produce uniform
irradiation of the lesions, a 25-mm collimating
lens was attached to the 5-mm fibre bundle.
Allowing at least a 10% margin around lesions in
the field of irradiation permitted the treatment
of lesions ≤ 21 mm in diameter, at a fluence rate
of 70 mW/cm2 and a treatment time of 30 min,
lesions received 125 J/cm2 . Following therapy,
3-mm punch biopsies were performed in lesions
where there was doubt over clinical clearance or
recurrence. Repeat treatments were administered
if lesions persisted
Comparator Cryotherapy: Liquid nitrogen
was applied to lesions via a hand-held Cry-Ac
spray. After initial ice field formation, the freeze
was maintained for 20 s. A single freeze–thaw
cycle technique was used with a 2–3 mm rim of
clinically healthy tissue included in the treatment
field. Following therapy, 3-mm punch biopsies
were performed in lesions where there was
doubt over clinical clearance or recurrence.
Repeat treatments were administered if lesions
persisted
Main eligibility
criteria Histological
confirmation of
Bowen’s with
individual lesions
≤ 21 mm in diameter.
No lesion had been
previously treated
Patient
characteristics
% Male: 16
Age range: 62–88 yr
Mean age: 76 yr
Location and no. of
lesions: legs 33, face
five, hand two
Concomitant
treatment Patients
were offered local
anaesthetic (1%
plain lidocaine by
intradermal injection)
during treatment
Authors Morton et al.
(1996) 71
Linked publications179 Data source Full
published paper
Country UK
Language English
Study design RCT
No. of participants
Total: 19 (40 lesions)
Intervention: 20 lesions,
participant no. not
stated
Comparator: 20 lesions,
participant no. not
stated
No. of recruiting
centres Not stated
Follow-up period
and frequency 2 d and
10 d for AEs. 2-monthly
intervals for clinical
response. Following
clearance, 2-monthly
intervals for 12 mth for
recurrence and late AEs
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