APPENDICES - NIHR Health Technology Assessment Programme

264
Appendix 17
Study details Population details Treatment details Results Interpretation
Authors’ conclusions PDT is safe and
effective for advanced oesophagocardiac
cancer. Its therapeutic effect can be further
improved when combined with local
chemotherapy
Brief study appraisal This study
was poorly reported (e.g. method of
randomisation, whether ITT analysis was
used) but most importantly it appears that
after over 40 patients had been treated,
interim analysis was carried out and all
subsequent patients were treated with
combined PDT and 5-FU. These analyses
were not further reported. Given this shift
from an RCT to experimental without a
comparator it is difficult to determine the
reliability of the study results overall
The authors’ conclusions do not follow from
the results reported
Mortality Mean survival time was 8.9 mth
with PDT alone compared with 15.1 mth
for PDT and 5-FU (p < 0.01)
Morbidity The rate of dysphagia
remission was 87% for PDT compared
with 99% with PDT and 5-FU (p < 0.05).
Differences in pharyngeal pain and weight
loss were not significant. With PDT alone
one patient achieved complete remission
(vs five with combined therapy, p < 0.05),
eight significant remission (vs 36) and five
no remission (vs nine). With combined
therapy 48 patients also achieved minor
remission
QoL and return to normal activity
Not assessed
AEs Subternal pain due to oesophageal
mucosa injury and gastroesophageal reflux
1–2 d after treatment was reported by
seven patients in PDT only and eight
patients in combination treatment
Eight patients in total accidentally exposed
themselves to sunlight and developed
discoloration of the skin
No oesophageal stenosis or perforation
reported in either group
Resource use Not assessed
Trial treatments PDT vs PDT with 5-FU
Intervention PDT: After intravenous
injection of the photosensitiser PSD-007
(photocarcinorin) (3–5 mg/kg bw) and
patients were kept in the dark. Irradiation
was performed at 24 and 48 hr with either
630-nm copper vapour pumped-dye laser
or 632.8 nm high power He-Ne laser (total
dose 200–400 J/cm fibre length, median
300 J/cm). This was delivered by cylindrical
diffusers under endoscope assistance.
Irradiation was carried out in one to four
segments (with slight overlap between
each segment) depending on lesion length
and diffuser. Treatment could be repeated
after 1 mth unless evaluation showed
effectiveness or symptoms were remitted.
Patients were advised to avoid sunlight
exposure for over 1 mth
Comparator PDT with 5-FU: As for
PDT but in addition, before irradiation,
200–500 mg 5-FU was locally injected into
tumour tissue under endoscopic guidance.
Before injection the extent of the lesions
was confirmed. Most patients received four
to eight injections per tumour
Treatment
intention Palliative
Type(s) of cancer
and histology
Advanced
oesophagocardiac
carcinoma
Main eligibility
criteria Biopsy
proven advanced
oesophageal
carcinoma
Patient
characteristics
% Male: 79
Age range: 40–81 yr
Median age: PDT 58;
PDT with 5-FU 62
Cancer stage: Stage
II 84; stage III 53;
stage IV 3
Concomitant
treatment Not
stated
Authors Zhang et al.
(2007) 113
Data source Full
published paper
Country China
Language English
Study design RCT
No. of participants
Total: 140
Intervention: 42
Comparator: 98
No. of recruiting
centres Not stated;
appears to be two
centres in China
Follow-up period
and frequency FU
at 1 mth. Over 70%
patients were followed
up for 12–36 mth