APPENDICES - NIHR Health Technology Assessment Programme

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234 Appendix 15 Study details Population details Treatment details Results Interpretation Authors’ conclusions The therapeutic outcome of this pilot study showed no difference between PDT with ALA and mALA. This preliminary result will require confirmation in further research Brief study appraisal This was a pilot study in preparation for a larger clinical trial. As such, it is likely to have been underpowered to detect statistically significant differences for at least some of the outcomes investigated. Treatment methods were well described but study methods, such as methods of randomisation, concealment of allocation and blinding, were not reported in detail Morbidity ALA group: 44 of 72 BCC (61%) showed a CR 12 wk after the 1st treatment vs mALA group: 23 of 40 BCC (58%) NS There was no statistically significant difference in partial successes (reduction of the diameter of the BCC of at least 50% of the initial tumour size) between the groups. Three tumours (4%) in the ALA group and one BCC (3%) did not respond to treatment and showed no reduction in tumour size. These patients were given surgical treatment. Eight BCCs in the ALA group and five in the mALA group developed a recurrence during the 6-mth period. After a second PDT, seven lesions in the ALA group and seven in the mALA group were treated successfully QoL and return to normal activity Not assessed AEs During illumination, eight ALA patients and five mALA patients experienced moderately painful sensations in the treated are (1–4 on the pain scale). Two patients in the mALA group had stabbing pain sensations (level 6–7 on the pain scale) during the laser application and had to be treated with local anaesthetic. Five patients in ALA group and two in mALA group felt moderate pain sensations up to the 3rd day post illumination (1–3 on the pain scale) Trial treatments ALA-based PDT vs mALA-based PDT Intervention ALA and mALA gels were prepared less than 1hr before treatment by dissolving in a cold (approx 4°C) thermo gel (Lutrol F-127) up to a concentration of 10% of ALA (mALA)/ml (w/v). The gel was applied 3 mm beyond the visible margin of the tumour and was approximately 5 mm thick. The area was covered with plaster and protected from light. 3 hr later, residues were removed and tumour areas circled with a blue skin marker. The lesion was then illuminated with a diode laser equipped with a microlens fibre. The power density was 0.1 W/cm2 and the energy density was 120 J/cm2 . A diameter of the irradiated area of approximately 10 mm was selected and distance laser-diffuser-skin corresponded to 15 mm. The procedure was performed with or without local anaesthesia according to the pain management needs of the patient. In cases where treatment was only partially successful, the therapy was repeated after the final examination (12th wk). Further PDT parameters were not reported Comparator See ‘Intervention’ for details Treatment intention Curative Type(s) of cancer and histology Superficial BCC Main eligibility criteria Histologically verified BCC of the skin, histologically proven superficial BCC with no deep infiltration (< 2 mm), no morpheic and pigmented BCC and good patient compliance. Exclusion criteria were: Unclear histology, clinically nBCC, expected poor compliance of the patient, untreated diabetes mellitus and pregnancy Patient characteristics % Male: 54 Age range: 42–96 yr Mean age 74 yr The vast majority of the tumours were located in the head and neck area. The average diameter of the lesions was 7 mm (range 3–12 mm). Three patients with GGS were included in the study Concomitant treatment Not stated Authors Schleier et al. (2007) 81 Data source Full published paper Country Germany Language English Study design RCT (between-participant comparison) No. of participants Total: 24 (112 lesions) Intervention: 13 Comparator: 11 No. of recruiting centres One Follow-up period and frequency 2, 4 and 12 wk and 6 mth after primary treatment GGS, Gorlin–Goltz syndrome.
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions Topical ALA– PDT with a broadband halogen light source gives cure rates and cosmetic outcome similar to those obtained with a laser source Brief study appraisal Although this was quite a well-conducted study, there were still issues which question the reliability of its results: the authors acknowledged that the optimum wavelength for ALA–PDT is 635 nm, but 630 nm was used for the laser group, for reasons of practicality; light doses varied between patients within a treatment group; and the M/F ratio differed substantially between the treatment groups Morbidity Overall, there were no statistically significant differences (p = 0.49) in response rates (complete, partial, or none) between the groups [CR was 95/111 lesions (86%) for laser vs 110/134 (82%) for lamp]. Patients with CR were followed up beyond the protocol 6-mth period. Data were presented, but not statistically analysed – recurrence after 2 yrs occurred in four lesions for the laser group, and five lesions for the lamp group QoL and return to normal activity Overall there were no statistically significant differences in cosmetic results (p = 0.075). Results were scored as being excellent or good in 80 lesions (84%) in the laser group vs 102 lesions (92%) in the lamp group AEs During the 1st wk after treatment 68% of the laser group and 74% of the lamp group patients reported some degree of discomfort (e.g. stinging, itching, pain). There were no statistically significant differences between the groups for AEs either during or after treatment. No SAEs were reported during 6-mth FU period Trial treatments PDT-laser vs PDTbroadband lamp Intervention PDT-laser: Pre-treatment with dressing soaked with 99% dimethylsulphoxide for 15 min followed by 20% ALA cream and covering with occlusive dressing for 3h. Cream was washed off before exposure to light of 630 nm from a copper vapour laser pumping a dye laser. Irradiance of 120–150 mW/cm2 , and a light dose of 100–150 J/cm2 (median dose 100 J/cm2 ) Comparator PDT-broadband lamp: As for PDT-laser except light source was a 150W halogen bulb broadband lamp, giving filtered light of between 570 and 740nm. Irradiance was 100–180 mW/cm2 and total light dose ranged from 150– 200 J/cm2 with median light dose of 200 J/cm2 . Total irradiance including infrared was 135–240 mW/cm2 Treatment intention Curative Type(s) of cancer and histology Superficial BCC Main eligibility criteria Patients with histologically/ cytologically confirmed superficial BCC with thickness < 1 mm, and diameter < 3 cm. Patients with fewer than six lesions Patient characteristics % Male: 47 Mean age: 62 yr All Caucasian Concomitant treatment Not stated Authors Soler et al. (2000) 82 Data source Full published paper Country Norway Language English Study design RCT (betweenparticipant comparison) No. of participants Total: 83 (245 lesions) Intervention: 41 (111 lesions) Comparator: 42 (134 lesions) No. of recruiting centres One Follow-up period and frequency FU at 1 wk, and 3 and 6 mth. Some participants also followed up after 1 and 2 yr © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 235
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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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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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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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