APPENDICES - NIHR Health Technology Assessment Programme

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Appendix 18 270 Study detailsPopulation details Treatment details Results Interpretation Authors’ conclusions Photofrin is at least similar to or better than Nd:YAG thermal ablation in re-establishing the patency of the obstructed lumen and palliating symptoms at wk 1 and mth 1 following treatment Brief study appraisal The very limited information provided, particularly on study methods and basic results (e.g. no numbers on randomisation by treatment group) makes assessment of reliability difficult Mortality Not assessed Morbidity CR + PR comparable between groups at wk 1 (PDT 65% vs Nd:YAG 61%), but significantly different at 1 mth (PDT 61% vs Nd:YAG 35%, p < 0.05). At 1 mth PDT also improved symptoms of dyspnoea (28% vs 13%), cough (33% vs 11%), haemoptysis (33% vs 19%), and sputum production (22% vs 14%), p-values not stated QoL and return to normal activity Not assessed AEs Mild-to-moderate skin photosensitivity in 21% of PDT patients. No further details Trial treatments PDT vs Nd:YAG laser Intervention 2 mg/kg of Photofrin followed 48 hr later by light activation Light source and duration, wavelength of light, power density, total light dose, maximum no. of sessions allowed, and postoperative advice not stated Comparator No details provided Treatment intention Palliative Type of Lung Cancer and Histology Non-small cell Main eligibility criteria Not stated Patient characteristics Not stated Concomitant treatment Not stated Authors Leroy et al. (1998) 125 Linked publications212 Data source Abstract Country Not stated Language English Study design RCT No. of participants Total: 141 Intervention: Not stated Comparator: Not stated No. of Recruiting Centres Not stated Follow-up period and frequency FU at 1 wk and 1 mth
Study details Population details Treatment details Results Interpretation DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Authors’ conclusions Photosan seems to be more effective than ALA in PDT of malignant tracheobronchial stenosis. However, these results would need confirming in a randomised, blinded trial Brief study appraisal This small pilot study was non-randomised and the groups had differences at baseline which may have impacted on results. The survival data do not solely reflect the effectiveness of the PDT treatment, as 4 wk after PDT patients were eligible to receive a variety of other treatments. There are also doubts as to whether the ALA dosage was optimal Mortality The mean survival for the ALA group was 9 mth and the Photosan group 14 mth (p = 0.020) Morbidity 4 wk FU In the ALA group, stenosis diameter dropped from a mean value of 79% to 63%. In the Photosan group the mean value dropped from 50% to 19%, p = 0.00073, in favour of Photosan. Dyspnoea was improved in 10/16 ALA patients and 19/24 Photosan patients. Haemoptysis subsided in 13/16 ALA patients and 20/24 Photosan patients. Radiological and clinical signs of poststenotic pneumonia subsided in 5/9 ALA patients and 9/13 Photosan patients. There was no statistically significant difference between groups on pulmonary function parameters QoL and return to normal activity Mean Karnofsky value changed from 78 to 79 in the ALA group, and from 70 to 78 in the Photosan group, showing a significant difference in favour of the Photosan group (p = 0.00015). One patient had an improvement of 10% in the ALA group, whereas 11 patients in the Photosan group improved by 10% and five improved by 20%. None of the patients in the Photosan group reported a decrease in QoL due to long-lasting need for skin protection AEs No sunburn occurred in either group. No major complications relating to photosensitisation, PDT or HBO were observed. Minor complications were: fever in the afternoon after PDT (12 in ALA group, 18 in Photosan group) and mild chest pain for 1 or 2 d (6 in the ALA group and 13 in the Photosan group). None of the AEs required specific treatment Trial treatments PDT with 5-ALA and HBO vs PDT with Photosan and HBO Intervention ALA was orally administered at a dose of 60 mg/kg, 6–8 hr prior to PDT In cases of severe tumour stenosis, PDT was carried out by using a fibre with a 2-cm tip radial light-diffusing cylinder, which was inserted through the biopsy channel of the endoscope. In cases of moderate tumour stenosis a 2-cm balloon applicator system was used for homogeneous light distribution. During treatment the radial light diffusing cylinder and/or balloon applicator system was closely applied to the surface of the tumour. The light dose was 100 J/cm2 . Light at 630 nm was applied by a KTP-Nd: YAG laser with a DYE module. In both groups additional hyperbaric oxygenation at a level of 2 ATA in a walk-in hyperbaric chamber was undertaken. Oxygen was applied using a Scuba valve system. Each treatment was performed under short-term intravenous anaesthesia with endotracheal intubation and spontaneous breathing. Skin protection was managed by use of a camouflage (Covermark, Milan, Italy) for 24 hr after photosensitisation Comparator Photosan-3 was administered intravenously at a dosage of 2 mg/kg, 48 hr prior to PDT. See intervention for details of PDT delivery. Skin protection was by using a commercially available sun blocker for 12 wk Treatment intention Palliative Type of Lung Cancer and Histology Non-small cell Main eligibility criteria Patients with malignant tracheobronchial stenosis, not eligible for resection treatment because of poor performance status, functional and/ or anatomical inoperability, and/or refusing surgery Patient characteristics % Male: 75 Mean age: ALA, 64 yr; Photosan, 66 yr Cancer stage: Stage IIb, seven; Stage IIIa, 13; Stage IIIb, six; Stage IV, 14 Squamous cell 27, Adenocarcinoma 10, Large cell carcinoma three Stenosis mean (range): ALA, 79% (50–90%); Photosan, 50% (20–95%) 22 patients with radiological and clinical signs of poststenotic pneumonia Karnofsky status mean (range): ALA, 78 (60–90); Photosan, 70 (60–80) Further patient characteristics were reported Concomitant treatment At least 4 wk after combined PDT/ HBO, all patients were considered for further treatment, including high-dose rate brachyradiotherapy, external beam irradiation and/or chemotherapy Authors Maier et al. (2002) 127 Data source Full published paper Country Austria Language English Study design Non- RCT No. of participants Total: 40 Intervention: 16 Comparator: 24 No. of Recruiting Centres One Follow-up period and frequency 1 wk and 4 wk © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. ATA, atmosphere absolute. 271
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140 Appendix 6 18. Biel MA. Photody
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142 Appendix 6 63. Gonzalez-Perez R
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144 Appendix 6 treated with photody
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146 Appendix 6 aminolevulinic acid
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148 Appendix 6 carcinomas: 5 years
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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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