APPENDICES - NIHR Health Technology Assessment Programme

284
Appendix 21
Study details Population details Treatment details Results Interpretation
Authors’ conclusions PDT is effective
and safe for the treatment of advanced nasal
pharyngeal cancer and the management of
nasal obstruction
Brief study appraisal This small pilot
study provided no details on randomisation,
blinding and other study quality parameters
raising questions about the validity of
the results. Treatment details were well
described. It does not appear to have led on
to a larger study, though the authors rightly
stated that further investigation was needed
Mortality Not assessed
Morbidity Overall clinical response was
statistically significantly better with PDT
than chemotherapy (p = 0.001). No patients
achieved CR. The PDT group had more
patients with a significant response (i.e.
50% reduction for 1 mth, 12 vs 2). In those
patients with nasal obstructions PDT
produced more effective debulking (p = 0.04)
(subgroup of 16 patients, 7/8 improved vs
2/8)
QoL and return to normal activity PDT
group had a statistically significant greater
improvement in Karnofsky score (p = 0.02).
PDT group increased from 45 to 70 vs
chemotherapy group increased from 40 to
50
AEs All PDT related adverse effects and
reactions were tolerable. Treatment to
the laryngopharynx area resulted in slight
pain and increased nasal cavity secretion –
resolved in 3–5 d
One case of severe laryngopharynx swelling
and pain. Resolved with treatment 1 wk later,
may be related to light exposure
One case of photosensitivity dermatitis after
accidental exposure to daylight. Resolved
after treatment, 1 wk later
One case of skin pigmentation, no treatment
required
Trial treatments PDT vs Chemotherapy
(cisplatin and 5-FU)
Intervention Intravenous Photofrin of
2 mg/kg. Local anaesthetic (lidocaine) before
light (630 nm) at 200–300 J/cm from a diode
laser through a cylindrical diffuser (1–5 cm)
48 hr after injection. Light was applied to
one to three overlapping segments for
12 min per segment. Segments had at least a
0.5-cm margin beyond the lesion. After 48-hr
necrotic tissue removed by biopsy forceps
and newly exposed lesions were re-treated
after cleaning. Cleaning was repeated when
necessary. Patients asked to avoid sunlight
for 4–6 wk after treatment. Maximum
number of sessions was not stated
Comparator Cisplatin 80 mg/m2 and 5-FU
500 mg/m2 , both divided into five. Each cycle
lasted 4 wk. Two cycles were given
Treatment
intention Not stated,
appears palliative
Type(s) of cancer
and histology
Nasopharyngeal
carcinoma
Main eligibility
criteria Patients
who had relapsed
and who had failed
radiotherapy
Patient
characteristics
% Male: 80
Age range: 28–72
Mean age: 54 yr
Cancer stage: All
stage IV and had local
relapse. All had prior
(failed) radiotherapy;
some also had prior
chemotherapy,
6–12 mth before trial
treatment
Concomitant
treatment Antivomiting
treatment
for chemotherapy
group. Chinese herbs
(unspecified)
Authors Li et
al. (2006) 141
Data source
Full published
paper
Country China
Language
English
Study design
RCT
No. of
participants
Total: 30
Intervention: 15
Comparator: 15
No. of
recruiting
centres Not
stated
Follow-up
period and
frequency FU
at 1, 3 and 6
mth