APPENDICES - NIHR Health Technology Assessment Programme

More documents

Recommendations

Info

196 Appendix 13 Study details Population details Treatment details Results Interpretation Authors’ conclusions PD P 506 A-PDT patches are suitable for the treatment of up to eight AK lesions of mild to moderate intensity on the head and face, and 4-hr application results in excellent outcomes. Further Phase III trials are required to confirm these outcomes Brief study appraisal This study was relatively poorly reported making it difficult to assess the reliability of the methodology or results. The use of multiple centres in a small trial raises the possibility of centreeffects on treatment and outcomes. Patients were only followed up for 8 wk. No statistical test results were reported; therefore it is difficult to be confident in the conclusions of efficacy Morbidity The majority of lesions showed clearance 8 wk after PDT and the 4-hr incubation group showed the best response – estimated 86% clearance rate and this was ‘statistically selected as the best treatment’. All but 1 of the 12 centres found similar results (details not reported). In some patients, lesions that appeared ‘cleared’ at wk 4 then worsened by wk 8 – this effect was most apparent in the 0.5-hr group, and was not present in the 4-hr group QoL and return to normal activity Not assessed AEs Five patients reported AE considered to be related to the study treatment: headache, moderate epistaxis and mild increase of alanine transaminase. Local reactions during application and incubation included burning, pruritis and erythema – all but one case was rated as mild or moderate. Local reactions during illumination appeared to be dose dependent and ranged from 26% in the 0.5-hr group to 66% in the 4-hr group. Most frequent reactions were pain, burning and pruritis. One patient’s treatment was interrupted due to severe pain. Almost all patients had local reactions after treatment, with erythema, scabbing, desquamation, burning and pruritis being common. Patients with clearance experienced local reactions to a greater extent than patients without clearance Trial treatments Patch containing ALA (PD P 506 A) applied to lesions for 0.5, 1, 2 or 4 hr followed by illumination with red light Intervention PDT patch + 0.5-hr incubation: Between three and four lesions per patient were treated using a PDT patch (one patch per lesion) containing 8 mg of ALA. Patch is lightproof therefore provides occlusive protection. After patch was removed, lesion illuminated with red light (dose 37 J/cm2 , wavelength around 630 nm). Further PDT parameters were not reported Comparator PDT patch + 1-hr incubation: see above 2nd comparator PDT patch + 2-hr incubation: see above 3rd comparator PDT patch + 4-hr incubation: see above Treatment intention Curative Type(s) of lesion and histology AK (mild to moderate) Main eligibility criteria Caucasian males or females aged at least 18 yr with histologically confirmed mild to moderate AK. Lesions were required to have maximum diameter of 1.8 cm and interlesional distance of at least 1 cm. Patients with dermatological conditions likely to impact on results were excluded. Further eligibility criteria were reported Patient characteristics % Male: 74 Age range: 39–91 yr across groups Mean age: 72 yr, 72 yr, 70 yr, 70 yr, respectively, for the four treatment groups Most lesions were located on the scalp or forehead in all groups, severity was fairly evenly split between mild and moderate. Mean lesion diameter was similar across groups at around 8–9 cm Concomitant treatment Any other topical treatment able to affect AK not permitted 4 wk prior to and during study. No urea and salicylic acidcontaining preparations permitted 2 wk prior and during study Authors Hauschild et al. (2008) 55 Data source Full published paper Country Germany Language English Study design RCT No. of participants Total: 149: 146 patients completed study, of which 140 (520 lesions) were in the per protocol population Intervention: 34 (128 lesions) 0.5-hr incubation Comparator: 38 (138 lesions) 1-hr incubation 2nd Comparator: 34 (124 lesions) 2-hr incubation 3rd Comparator: 34 (130 lesions) 4-hr incubation No. of recruiting centres 12 Follow-up period and frequency 4 and 8 wk after treatment
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions The authors did not report any conclusions Brief study appraisal Little useful evidence could be retrieved from this abstract which provided very few methodological or result details, and involved a fairly small sample followed up for 16 wk Morbidity At 8 wk, 66% of AKs treated with ALA had a CR vs 17% with placebo (p < 0.001). At 16 wk. CR was seen in 56/66 (85%) of ALA–PDT patients (no results reported for placebo). AKs treated with ALA–PDT at 5 or 10 J/cm2 of light resulted in a significantly better response than the corresponding placebo group, although there was no significant difference between the groups at 2 J/cm2 QoL and return to normal activity Not assessed AEs The authors reported that hyperpigmentation was seen in 11% of AKs treated with ALA–PDT, which was not different from the placebo group. The treatment was well tolerated and no patients withdrew due to an AE Trial treatments ALA–PDT vs PDT with placebo (within-participant comparison) Intervention ALA–PDT: Two AKs were treated with 20% ALA solution (Levulan) and after 14- to 18-hr exposed to blue (non-laser) light at doses of 2, 5 and 10 J/cm2 . Patients were re-treated at 8 wk if necessary. Further PDT parameters were not reported Comparator Placebo PDT: As above except placebo control was used in place of ALA solution Treatment intention Curative Type(s) of lesion and histology AK Main eligibility criteria Patients with four AKs on the face and scalp Patient characteristics Not stated Concomitant treatment Not stated © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. Authors Jeffes et al. (1998) 41 Data source Abstract Country USA Language English Study design RCT No. of participants Total: 36 Intervention: 36 Comparator: 36 No. of recruiting centres Not stated multicentre Follow-up period and frequency 8 and 16 wk 197
Page 1 and 2:
Appendices July 2010 10.3310/hta143
Page 3 and 4:
DOI: 10.3310/hta14370 Health Techno
Page 5 and 6:
Page 7 and 8:
Page 9:
Page 12 and 13:
140 Appendix 6 18. Biel MA. Photody
Page 14 and 15:
142 Appendix 6 63. Gonzalez-Perez R
Page 16 and 17:
144 Appendix 6 treated with photody
Page 18 and 19: 146 Appendix 6 aminolevulinic acid
Page 20 and 21: 148 Appendix 6 carcinomas: 5 years
Page 23 and 24: DOI: 10.3310/hta14370 Health Techno
Page 35: DOI: 10.3310/hta14370 Health Techno
Page 38 and 39: 166 Appendix 9 photodynamic therapy
Page 40 and 41: 168 Appendix 9 of early-stage lung
Page 42 and 43: 170 Appendix 9 107. Okunaka T, Kato
Page 44 and 45: 172 Appendix 9 152. Kato H, Konaka
Page 51: DOI: 10.3310/hta14370 Health Techno
Page 54 and 55: 182 Appendix 12 as salvage treatmen
Page 56 and 57: 184 Appendix 12 63. Lorenz KJ, Maie
Page 58 and 59: 186 Appendix 12 107. Biel MA. Photo
Page 60 and 61: 188 Appendix 13 Study details Popul
Page 86 and 87: Appendix 13 214 Study details Popul
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Study details Population details Tr
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153:
Page 156 and 157:
284 Appendix 21 Study details Popul
Page 158 and 159:
Appendix 21 286 Study details Popul
Page 162:
Feedback The HTA programme and the
show all

APPENDICES - NIHR Health Technology Assessment Programme

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?