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 with 514-nm
light has the potential to cure superficial
cancer in the oesophagus and bronchi with
the same probability as 630-nm PDT. In
the oesophagus, green light prevents deep
tissue damage, thus reducing the risk of
perforation
Brief study appraisal The numbers
included in this study were small and the
methods were not clearly reported –
particularly in terms of comparability of
the two groups. The conclusions may not
therefore be reliable. Note: The majority
of patients in this trial had oesophageal
tumours (14/22), therefore the results have
been included in the oesophageal cancer
group
Mortality Not assessed
Morbidity CR was seen in 9/13 of the
superficial tumours (69%) with 630-nm PDT
vs 6/9 tumours (67%) with 514-nm PDT.
In the 630-nm PDT group three tumours
showed a PR (vs three in 524-nm group)
and one tumour only minimally reduced in
size. In the oesophagus, both wavelengths
were effective in eradicating in situ and
intramucosal cancer but did both cure more
than half of the submucosal tumours. 2/10
tumours treated at a drug–light interval of
1 hr achieved a CR
QoL and return to normal activity Not
assessed
AEs No major complications were
observed in either treatment group. Three
630-nm PDT patients reported chest pains
with associated high-grade fever for 10 d
after PDT (two with pleural effusion, the
3rd with endoscopic evidence of oedema
and erythema on the posterior wall of the
trachea at the level of the oesophageal
cancer). All three patients recovered with
antimicrobial therapy
Resource use Not assessed
Trial treatments PDT at 630 nm with
Photofrin II vs PDT at 514 nm with
Photofrin II
Intervention PDT with Photofrin
(630 nm): After injection with Photofrin
II (1 or 2 mg/kg) irradiation with 630 nm,
100 mW/cm2 (total dose 100 J/cm2 ) argon
ion pumped-dye laser under general
anaesthetic. Microlens and/or cylindrical
light distributors were used in the bronchi
and 180 or 240° windowed cylindrical light
distributors in the oesophagus. Ten tumours
had a drug–light interval of 72 hr, three
tumours had a drug–light interval of 1 hr. If
there was less than CR at 3-mth endoscopy,
PDT was repeated. Patients were advised to
avoid direct sunlight for 4–6 wk after drug
administration
Comparator PDT at 514 nm: As for
PDT at 630 nm but using 514 nm and five
tumours had a drug–light interval of 72 h,
four tumours had a drug–light interval of
1 hr
Treatment
intention Curative
Type(s) of cancer
and histology
Superficial
oesophageal and
bronchial cancers
Main eligibility
criteria It appeared
that men and women
with one or several
biopsy-proven
superficial SCC
of the bronchi or
oesophagus
Patient
characteristics
% Male: 80
Age range: 46–79 yr
Mean Age: 59.8 yr
All patients had
previously received
radiotherapy and/or
surgery for primary
invasive cancer of the
head and neck
Concomitant
treatment Not
stated
Authors
Grosjean et al.
(1998) 108
Data source Full
published paper
Country
Switzerland
Language English
Study design
Non-RCT
No. of
participants
Total: 15 (22
tumours)
Intervention: 13
tumours (630 nm
PDT)
Comparator: Nine
tumours (514 nm
PDT)
No. of recruiting
centres Not
stated
Follow-up
period and
frequency FU at
7–10 d, then 3 mth
after treatment
and twice per year
thereafter
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