APPENDICES - NIHR Health Technology Assessment Programme

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266 Appendix 18 Study details Population details Treatment details Results Interpretation Authors’ conclusions No conclusions specific to PDT Brief study appraisal This small study was an interim analysis of a RCT presented in abstract form. Although it indicated that updated results would be presented, no further information could be located. Most of the study’s methodological details were not available from the abstract and the majority of the results were not broken down by treatment group Mortality Assessed but not reported per group Morbidity Not assessed AEs Minor haemoptysis in two PDT- ERT patients. Skin photosensitivity was acceptable in patients treated with PDT (no data provided). Other AEs reported but not broken down by group Trial treatments ERT alone vs PDT preceding ERT vs HDR preceding ERT Intervention Photofrin 2 mg/kg, 200 J/cm, 630 nm given 2 wk before ERT. Other PDT parameters not stated Comparator ERT alone: 14 x 2.5 + 8 x 2.5 Gy to the tumour area in 4 wk 2nd comparator HDR + ERT: As above preceded by HDR: 15 Gy at 1-cm distance along the tumour 2 wk before ERT Treatment intention Palliative Type of Lung Cancer and Histology Non-small cell; no further details given Main eligibility criteria Histologically proven inoperable locoregional NSCLC, weight loss < 10% and a PS (sic) > 70% Patient characteristics % Male: 88 Concomitant treatment Not stated Authors Baas et al. (1994) 121 Data source Abstract Country The Netherlands Language English Study design RCT No. of participants Total: 39 Intervention: 15 Comparator: 12 2nd Comparator: 12 No. of Recruiting Centres Not stated Follow-up period and frequency Not stated
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT is a valid method of palliation in partially or totally obstructing NSCLC Brief study appraisal Difficult to evaluate results due to important baseline differences (presence of cough, and stage of cancer) between groups. Karnofsky performance and FU after 1 mth assessed but not reported. No details on blinding Mortality Survival significantly longer in PDT group (265 vs 95 d, p = 0.007). 4/14 (PDT) and 4/17 (Nd:YAG) still alive at end of study Morbidity Similar response in both groups: 38.5% PDT vs 23.5% Nd:YAG at 1 mth (p = ns). PR at 1 mth in three PDT and four Nd:YAG patients. CR at 1 mth in one PDT patient. Time elapsed until treatment failure: 50 d (PDT) vs 38 d (Nd:YAG) (p = 0.03) QoL and return to normal activity Assessed but not reported AEs Bronchitis was the most common (four cases in PDT group, one in Nd:YAG group) Photosensitisation in four PDT patients. Five patients had no AEs, all in Nd:YAG group. One death probably related to PDT Trial treatments PDT vs Nd:YAG laser resection Intervention Intravenous DHE at dose of 2 mg/kg with 630-nm argon dye laser, 40–50 hr after injection. Maximum of three doses (six photoradiations). Other parameters not reported Comparator Nd:YAG resection using 15- to 80-W pulses of 0.5–1.5 s. Procedure repeated every 2–4 d as necessary Treatment intention Palliative Types of Lung Cancer and Histology Non-small cell 25 SCC, three adenocarcinoma, three undifferentiated carcinoma Main eligibility criteria Biopsyproven inoperable cancer with totally or partially obstructive endobronchial lesions with or without extrabronchial tumour. Patients > 18 yr, nonpregnant, infertile or postmenopausal. Karnofsky status ≥ 40%, ≥ 4 wk from last chemotherapy cycle and ≥ 3 wk from last radiation dose. Patients who had previous PDT or Nd:YAG were excluded. Further eligibility criteria were reported Patient characteristics % Male: 100 Age range: Not stated Mean age: 65 yr Cancer stage: Stage I, four patients; stage II, one; stage IIIA, six; stage IIIB, 10; stage IV, seven No. with recurrent tumour: three Concomitant treatment Not stated Authors Diaz- Jimenez et al. (1999) 122 Data source Full published paper Country Spain Language English Study Design RCT No. of participants Total: 31 Intervention: 14 Comparator: 17 No. of Recruiting Centres Not stated Follow-up period and frequency FU at 1, 2, 3, 6 and 12 mth (and 18 mth if possible) © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 267
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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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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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188 Appendix 13 Study details Popul
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APPENDICES - NIHR Health Technology Assessment Programme

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