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 Radiotherapy<br />
combined with PDT could obviously<br />
enhance the long-term survival rate of<br />
patients with advanced oesophageal<br />
cancer<br />
Brief study appraisal This was a<br />
brief report and some methodological<br />
aspects were not clearly reported.<br />
The p-values were not reported<br />
consistently between the abstract and<br />
the text making it difficult to clarify the<br />
significant differences between groups<br />
Mortality The 5-yr survival rate was<br />
29.9% in the PDT group compared with<br />
16.7% (p = 0.05). The 10-yr survival rate<br />
was 16.7% in the PDT group vs 10.0%<br />
(p < 0.05)<br />
Morbidity Not assessed<br />
QoL and return to normal activity<br />
Not assessed<br />
AEs All PDT patients experienced<br />
pigmentation, and swelling and itchiness.<br />
All PDT patients also experienced<br />
pain when swallowing for 3–5 d<br />
(some patients had pain for > 10 d<br />
and discontinued treatment). 23 died<br />
in the PDT group: loss to FU two;<br />
uncontrolled localisation 13 including<br />
one due to blockage of oesophagus;<br />
metastases eight; other disease one;<br />
unknown cause one. 26 died in the<br />
radiotherapy group: loss to FU one;<br />
uncontrolled localisation 18, including<br />
two due to blockage of oesophagus;<br />
metastases four; other disease two;<br />
unknown cause two<br />
Resource use Not assessed<br />
Trial treatments PDT with<br />
radiotherapy vs radiotherapy alone<br />
Intervention PDT with radiotherapy:<br />
Radiotherapy for 4 wk (40 Gy). Then<br />
intravenous haematoporphyrin<br />
derivative (5 mg/kg bw) before<br />
illumination with 630-nm red light (400–<br />
500 W/cm2 at each part of the tumour<br />
for 15 min) at 48 and 72 hr<br />
Comparator Radiotherapy: 40 Gy for<br />
4 wk<br />
Treatment intention<br />
Palliative<br />
Type(s) of cancer and<br />
histology Advanced<br />
oesophageal cancer<br />
Main eligibility criteria<br />
Diagnosed with advanced<br />
oesophageal cancer, suitable<br />
for treatment<br />
Patient characteristics<br />
Age: under 70 yr<br />
Cancer length: 5–10 cm. No<br />
metastases<br />
Concomitant treatment<br />
Not stated<br />
Authors Zhang et al.<br />
(2003) 119<br />
Data source Full<br />
published paper<br />
Country China<br />
Language Chinese<br />
Study design RCT<br />
No. of participants<br />
Total: 60<br />
Intervention: 30<br />
Comparator: 30<br />
No. of recruiting<br />
centres One hospital<br />
(outpatients)<br />
Follow-up period<br />
and frequency FU at<br />
5 and 10 yr<br />
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