APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
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DOI: 10.3310/hta14370 <strong>Health</strong> <strong>Technology</strong> <strong>Assessment</strong> 2010; Vol. 14: No. 37<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions Increasing<br />
the light dose increases the odds of<br />
having permanent neurological deficit,<br />
but does not increase survival time,<br />
or time to tumour progression. There<br />
was no difference in recurrence with<br />
increasing light dose<br />
Brief study appraisal This nonrandomised<br />
study appeared to have<br />
far too small a sample size to provide<br />
clinically meaningful results. Results<br />
were not always provided for all three<br />
groups<br />
Mortality Mean survival time was<br />
314 d (sd = 106) in group 2 vs 238 d in<br />
group 3 (sd = 61). Group 1 not stated<br />
Morbidity 16 patients had<br />
recurrence after PDT (four in group<br />
1, six in group 2 and six in group 3),<br />
and two did not. Time to tumour<br />
recurrence was a mean of 150 d in<br />
group 2 vs 131d in group 3. Group 1<br />
not stated<br />
QoL and return to normal<br />
activity Median Karnofsky rating<br />
changed from 90 (pre-PDT) to 85<br />
(post PDT)<br />
AEs Five patients had postoperative<br />
permanent neurological defects (zero<br />
in group 1, two in group 2, and three<br />
in group 3)<br />
Resource use Not assessed<br />
Trial treatments PDT 1500–3700 J<br />
vs PDT 3700–4400 J vs PDT 4400–<br />
5900 J<br />
Intervention PDT 1500–3700 J<br />
(group 1): Intravenous Photofrin<br />
at 2 mg/kg, followed 24 hr later<br />
by anaesthetic and CT or MRI<br />
scan which locates tumour using<br />
stereotactic arc system. Six optical<br />
diffusion tip fibres (1.6 mm) and<br />
central fibre inserted through drill<br />
holes into skull. Red light (630 nm)<br />
from an argon pumped-dye laser was<br />
delivered through optical fibres and<br />
beam splitters to individual diffusion<br />
tip fibres. Tumours were biopsied<br />
(and if no malignancy was found the<br />
patient was excluded from the study).<br />
Patients were advised about sunlight<br />
protection, and about avoiding direct<br />
sunlight and bright artificial light for<br />
6 wk<br />
Comparator PDT 3700–4400 J<br />
(group 2): See above<br />
2nd comparator PDT 4400–5900 J<br />
(group 3): See above<br />
Treatment intention Curative<br />
Palliative<br />
Type(s) of cancer and histology<br />
12 glioblastoma, five anaplastic<br />
astrocytoma, one malignant<br />
ependymoma<br />
Main eligibility criteria Patients<br />
aged 18–75 yr, with supratentorial<br />
primary malignant brain tumours<br />
≤ 5 cm in diameter, a Karnofsky<br />
rating ≥ 60, and who had recurrent<br />
or residual tumours were eligible.<br />
Patients had to have received<br />
radiation therapy > 3 mth prior to<br />
PDT treatment. Further eligibility<br />
criteria were reported<br />
Patient characteristics<br />
Age range: 32–70 yr<br />
Median Karnofsky score: 90<br />
Tumour locations also reported. All<br />
patients had initial surgery, radiation<br />
therapy and chemotherapy before<br />
recurrence<br />
Concomitant treatment Steroid<br />
therapy if required<br />
Authors<br />
Krishnamurthy et al.<br />
(2000) 138<br />
Data source Full<br />
published paper<br />
Country USA<br />
Language English<br />
Study design<br />
Non-RCT<br />
No. of<br />
participants<br />
Total: 18<br />
Intervention: Six<br />
Comparator: Six<br />
2nd Comparator:<br />
Six<br />
No. of recruiting<br />
centres One<br />
Follow-up period<br />
and frequency<br />
Days 1 and 2, at<br />
discharge from<br />
hospital, at 1, 4 and<br />
6 wk, then at 3-mth<br />
intervals<br />
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