APPENDICES - NIHR Health Technology Assessment Programme

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Appendix 15
Study details Population details Treatment details Results Interpretation
Authors’ conclusions The therapeutic
outcome of this pilot study showed
no difference between PDT with ALA
and mALA. This preliminary result will
require confirmation in further research
Brief study appraisal This was a pilot
study in preparation for a larger clinical
trial. As such, it is likely to have been
underpowered to detect statistically
significant differences for at least some
of the outcomes investigated. Treatment
methods were well described but
study methods, such as methods of
randomisation, concealment of allocation
and blinding, were not reported in detail
Morbidity ALA group: 44 of 72 BCC
(61%) showed a CR 12 wk after the 1st
treatment vs mALA group: 23 of 40 BCC
(58%) NS
There was no statistically significant
difference in partial successes (reduction
of the diameter of the BCC of at least
50% of the initial tumour size) between
the groups. Three tumours (4%) in the
ALA group and one BCC (3%) did not
respond to treatment and showed no
reduction in tumour size. These patients
were given surgical treatment. Eight
BCCs in the ALA group and five in the
mALA group developed a recurrence
during the 6-mth period. After a second
PDT, seven lesions in the ALA group and
seven in the mALA group were treated
successfully
QoL and return to normal activity
Not assessed
AEs During illumination, eight ALA
patients and five mALA patients
experienced moderately painful
sensations in the treated are (1–4 on the
pain scale). Two patients in the mALA
group had stabbing pain sensations
(level 6–7 on the pain scale) during the
laser application and had to be treated
with local anaesthetic. Five patients in
ALA group and two in mALA group felt
moderate pain sensations up to the 3rd
day post illumination (1–3 on the pain
scale)
Trial treatments ALA-based PDT vs
mALA-based PDT
Intervention ALA and mALA gels
were prepared less than 1hr before
treatment by dissolving in a cold (approx
4°C) thermo gel (Lutrol F-127) up to a
concentration of 10% of ALA (mALA)/ml
(w/v). The gel was applied 3 mm beyond
the visible margin of the tumour and was
approximately 5 mm thick. The area was
covered with plaster and protected from
light. 3 hr later, residues were removed
and tumour areas circled with a blue skin
marker. The lesion was then illuminated
with a diode laser equipped with a
microlens fibre. The power density was
0.1 W/cm2 and the energy density was
120 J/cm2 . A diameter of the irradiated
area of approximately 10 mm was
selected and distance laser-diffuser-skin
corresponded to 15 mm. The procedure
was performed with or without local
anaesthesia according to the pain
management needs of the patient. In
cases where treatment was only partially
successful, the therapy was repeated
after the final examination (12th wk).
Further PDT parameters were not
reported
Comparator See ‘Intervention’ for
details
Treatment intention
Curative
Type(s) of cancer and
histology Superficial
BCC
Main eligibility
criteria Histologically
verified BCC of the skin,
histologically proven
superficial BCC with
no deep infiltration
(< 2 mm), no morpheic
and pigmented BCC and
good patient compliance.
Exclusion criteria were:
Unclear histology,
clinically nBCC, expected
poor compliance of
the patient, untreated
diabetes mellitus and
pregnancy
Patient
characteristics
% Male: 54
Age range: 42–96 yr
Mean age 74 yr
The vast majority of the
tumours were located in
the head and neck area.
The average diameter
of the lesions was 7 mm
(range 3–12 mm). Three
patients with GGS were
included in the study
Concomitant
treatment Not stated
Authors Schleier et al.
(2007) 81
Data source Full
published paper
Country Germany
Language English
Study design RCT
(between-participant
comparison)
No. of participants
Total: 24 (112 lesions)
Intervention: 13
Comparator: 11
No. of recruiting
centres One
Follow-up period
and frequency 2, 4
and 12 wk and 6 mth
after primary treatment
GGS, Gorlin–Goltz syndrome.