APPENDICES - NIHR Health Technology Assessment Programme

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Appendix 20 280 Study details Population details Treatment detailsResults Interpretation Authors’ conclusions ALA and Photofrin fluorescence-guided resection with repetitive PDT offer a worthwhile survival advantage, without added risk, to patients with GBM Brief study appraisal The Karnofsky results were reported inconsistently within the paper, making interpretation difficult. It was unclear how many patients had actually been randomised and treated, as 14 patients with negative biopsy results were subsequently excluded from analyses. The analysed population does not therefore appear to reflect the population presenting clinically (patients with an MRI diagnosis). Although the study made use of blinding to assess outcomes, it was nevertheless unclear whether suitable methods had been used to randomise and allocate participants to treatments. No results were reported on possible photosensitisation effects. The authors did though acknowledge the need for a much larger study Mortality Mean survival in the PDT group was 52.8 wk vs 24.2 wk in the surgery group (p < 0.001) Morbidity There was no residual tumour on discharge scan in 10/13 PDT patients vs 4/14 surgery patients. Mean time to tumour progression was 8.6 mth in the PDT group vs 4.8 mth in the surgery group (p < 0.01) QoL and return to normal activity The Karnofsky score at 6 mth had improved from 70 (at baseline) to 80 in the PDT group, although the authors reported an improvement of 20 points. The scores remained the same for the surgery group (at 70) AEs Three patients had deep vein thrombosis, two of which were in the PDT group. No infections or seizures occurred Resource use There was no difference between the groups in length of hospital stay (both had a mean stay of 7 d) Trial treatments Fluorescence-guided resection and repetitive PDT and radiotherapy vs standard resection and radiotherapy Intervention PDT: Patients were given 2 mg/kg Photofrin intravenously 48 h before surgery, and 20 mg/kg ALA orally 3 h before surgery. After removal of bulk of tumour violet-blue light (375–440 nm) with a 440-nm observation filter was used to illuminate the cavity with fluorescence detected by a high-quality photodiagnosis camera, and detected tumour was removed until no further fluorescence was detected. A laser-based (405 nm) protoporphyrin-IX spectroscopy detection system was used to detect any remaining tumour cells at the margins, which were removed. A size- 10 balloon catheter was inflated to fit the cavity with 0.8% intralipid solution. After the patient awoke from surgery the 1st PDT treatment, using 630-nm diode laser (600 mW), was given in theatre recovery at 100 J/cm2 ; more PDT was given at 72, 96, 120 and 144 hr. Patients also received standard radiotherapy. Advice was given on sun protection measures Comparator Tumour removal using the same neuronavigation and surgical microscope as the PDT group. Patients also received standard radiotherapy Treatment intention Curative Type(s) of cancer and histology GBM Main Eligibility Criteria Patients over 17 yr, with a new MRI diagnosis of GBM and a Karnofsky score ≥ 60 Patient characteristics % Male: 67 Mean age: 59.8 yr Mean Karnofsky performance score: 70 Concomitant treatment Some study patients received additional treatments such as chemotherapy and further surgery. However, there were no statistically significant differences between the groups in patients receiving additional treatments Authors Eljamel et al. (2008) 139 Data source Full published paper Country UK Language English Study design RCT No. of participants Total: 27 analysed (42 randomised?) Intervention: 13 Comparator: 14 No. of recruiting centres One Follow-up period and frequency 3-monthly, until death GBM, glioblastoma multiforme; MRI, magnetic resonance imaging.
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions Increasing the light dose increases the odds of having permanent neurological deficit, but does not increase survival time, or time to tumour progression. There was no difference in recurrence with increasing light dose Brief study appraisal This nonrandomised study appeared to have far too small a sample size to provide clinically meaningful results. Results were not always provided for all three groups Mortality Mean survival time was 314 d (sd = 106) in group 2 vs 238 d in group 3 (sd = 61). Group 1 not stated Morbidity 16 patients had recurrence after PDT (four in group 1, six in group 2 and six in group 3), and two did not. Time to tumour recurrence was a mean of 150 d in group 2 vs 131d in group 3. Group 1 not stated QoL and return to normal activity Median Karnofsky rating changed from 90 (pre-PDT) to 85 (post PDT) AEs Five patients had postoperative permanent neurological defects (zero in group 1, two in group 2, and three in group 3) Resource use Not assessed Trial treatments PDT 1500–3700 J vs PDT 3700–4400 J vs PDT 4400– 5900 J Intervention PDT 1500–3700 J (group 1): Intravenous Photofrin at 2 mg/kg, followed 24 hr later by anaesthetic and CT or MRI scan which locates tumour using stereotactic arc system. Six optical diffusion tip fibres (1.6 mm) and central fibre inserted through drill holes into skull. Red light (630 nm) from an argon pumped-dye laser was delivered through optical fibres and beam splitters to individual diffusion tip fibres. Tumours were biopsied (and if no malignancy was found the patient was excluded from the study). Patients were advised about sunlight protection, and about avoiding direct sunlight and bright artificial light for 6 wk Comparator PDT 3700–4400 J (group 2): See above 2nd comparator PDT 4400–5900 J (group 3): See above Treatment intention Curative Palliative Type(s) of cancer and histology 12 glioblastoma, five anaplastic astrocytoma, one malignant ependymoma Main eligibility criteria Patients aged 18–75 yr, with supratentorial primary malignant brain tumours ≤ 5 cm in diameter, a Karnofsky rating ≥ 60, and who had recurrent or residual tumours were eligible. Patients had to have received radiation therapy > 3 mth prior to PDT treatment. Further eligibility criteria were reported Patient characteristics Age range: 32–70 yr Median Karnofsky score: 90 Tumour locations also reported. All patients had initial surgery, radiation therapy and chemotherapy before recurrence Concomitant treatment Steroid therapy if required Authors Krishnamurthy et al. (2000) 138 Data source Full published paper Country USA Language English Study design Non-RCT No. of participants Total: 18 Intervention: Six Comparator: Six 2nd Comparator: Six No. of recruiting centres One Follow-up period and frequency Days 1 and 2, at discharge from hospital, at 1, 4 and 6 wk, then at 3-mth intervals © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 281
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140 Appendix 6 18. Biel MA. Photody
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146 Appendix 6 aminolevulinic acid
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166 Appendix 9 photodynamic therapy
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168 Appendix 9 of early-stage lung
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170 Appendix 9 107. Okunaka T, Kato
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172 Appendix 9 152. Kato H, Konaka
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182 Appendix 12 as salvage treatmen
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184 Appendix 12 63. Lorenz KJ, Maie
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186 Appendix 12 107. Biel MA. Photo
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188 Appendix 13 Study details Popul
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APPENDICES - NIHR Health Technology Assessment Programme

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