APPENDICES - NIHR Health Technology Assessment Programme

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190 Appendix 13 Study details Population details Treatment details Results Interpretation Authors’ conclusions Photobleaching rate and primary treatment outcomes are dependent on fluence rate. A low fluence rate (30 mW/cm2 ) seems preferable when performing PDT of AK using noncoherent light sources Brief study appraisal The details of this small trial were poorly reported therefore the reliability of the conclusions is unclear; however, the authors acknowledge that a larger RCT is required Morbidity There was a significant correlation between fluence rate and treatment outcome (p < 0.02); the highest number of patients with complete remission was in the 30 mW/cm2 (narrow filter) group (8/9 patients). There was a non-significant trend towards a smaller proportion of remaining AK for the narrow filter (p = 0.07). No significant difference was found between 45 mW/cm2 (narrow) and 50mW (broad) groups implying preferable treatment outcome was attributable to fluence rate not spectral emission QoL and return to normal activity Not assessed AEs There was no significant correlation between fluence rate and VAS score. The VAS value increased up to a peak after a cumulative light dose of 20 J/cm2 Trial treatments ALA–PDT 50 mW/cm2 (broad filter) vs ALA–PDT 75 mW/cm2 (broad filter) vs ALA–PDT 30 mW/cm2 (narrow filter) vs ALA– PDT 45 mW/cm2 (narrow filter). Total dose 100 J/cm2 (all treatments) Intervention ALA–PDT: Crusts and scales were removed then 20% ALA cream was applied using an occlusive bandage and removed after 3 hr. The Photo Demarcation System 1, Prototype 5, was used to deliver 50 mW/cm2 , total dose 100 J/cm2 . Fluorescence imaging recordings (365 and 405 nm, 0.5 mW/cm2 ) took place before treatment, during treatment (after 5, 10, 20 and 40 J/cm2 ) and after finishing treatment (100 J/cm2 ) Comparator ALA–PDT with 75 mW/cm2 (broad filter); other treatment details as before 2nd comparator ALA–PDT with 30 mW/cm2 (narrow filter); other treatment details as before 3rd comparator ALA–PDT with 45 mW/cm2 (narrow filter); other treatment details as before Treatment intention Curative Type(s) of lesion and histology AK Main eligibility criteria Clinically typical AK; either one AK lesion, minimum diameter of 20 mm, or three lesions within area exceeding 25 cm2 Patient characteristics % Male: 80 Mean age: 71 yr Lesions were located on the face, scalp, neck and upper chest Concomitant treatment Not stated Authors Ericson et al. (2004) 43 Data source Full published paper Country Sweden Language English Study design RCT No. of participants Total: 40 (37 analysed) Intervention: Nine (broad filter, 50 mW/cm2 ) Comparator: 10 (broad filter, 75 mW/cm2 ) 2nd Comparator: Nine (narrow filter, 30 mW/cm2 ) 3rd Comparator: Nine (narrow filter, 45 mW/cm2 ) No. of recruiting centres Multicentre Follow-up period and Frequency 7 wk
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions The excellent shortand long-term cosmetic results, low recurrence rate and high rate of patient and physician satisfaction associated with ALA–PDT indicate definite advantages over other existing treatment modalities for AK Brief study appraisal Few methodological details were reported, and details of the study population were unclear. The sources of information appeared contradictory in reporting that FU both ceased at 12 mth, and also continued for 4 yr. The 4-yr results were presented for just four patients and this, coupled with the lack of a clinically relevant comparison treatment, further questions the reliability of the authors’ conclusions. (Attempts were made to contact authors for further details.) Morbidity At wk 8, CR rate (100%), by no. of patients: ALA-018: 60/87 (69%) ALA–PDT vs 4/29 (14%) placebo ALA-019: 59/93 (63%) ALA–PDT vs 4/32 (13%) placebo At wk 8, > 75% clearance rate, by no. of patients: ALA-018: 68/87 (78%) ALA–PDT vs 6/29 (21%) placebo ALA-019: 71/93(76%) ALA–PDT vs 8/32 (25%) placebo When results for the two trials were pooled, the CR rate, for number of lesions, was: Lesion grade I: 666/756 (88%) ALA–PDT vs 122/302 (40%) placebo Lesion grade II: 495/632 (78%) ALA–PDT vs 52/199 (26%) placebo 34% of patients were re-treated at 8 wk At wk 12 CR rate was 129/180 (72%) in the ALA–PDT group vs 7/61(11%) in placebo treated patients. A response rate of least 75% was reported in 158/180 (88%) of ALA–PDT patients vs 12/61(20%) placebo-treated patients. The clearance rate was higher for facial lesions than scalp lesions At 4 yr after PDT, of 32 lesions in four patients (PDT group), 69% (22) remained cleared, 9% (3) were ‘recurrent’ and 22% (7) were ‘uncertain’. Further results were reported QoL and return to normal activity For ALA–PDT cosmetic response was rated as ‘good’ to ‘excellent’ by investigators in 92% of lesions; patients rated cosmetic response as ‘good’ to ‘excellent’ in 94% AK lesions; 85% of patients previously treated with 5-FU or cryotherapy indicated a preference for ALA–PDT for future management AEs Severe stinging and/or burning was reported by at least 50% of PDT patients; less than 3% stopped treatment. In 99% of PDT patients, some or all lesions were erythematous shortly after treatment vs 79% in the placebo group. In 35% of PDT patients some or all lesions were oedematous vs 0% in the placebo group. Both types of AE resolved or improved by 4 wk. More ALA patients also reported postPDT itching (26% vs 7%) Seven patients had an SAE – all were deemed remotely, or not related to, treatment Trial treatments ALA–PDT vs PDT with placebo cream Intervention ALA–PDT: Topical 20% ALA and 10 J/cm2 of visible blue light (from the BLU-U illuminator, for 1000 s) were applied. Lesions that had not cleared were re-treated at 8 wk and all patients were re-evaluated at 12 wk. After 12-wk long-term lesion recurrence was based on complete chart review (including lesion photographs and treatment during most recent patient visits at wk 36–48) Comparator Not described Treatment intention Curative Type(s) of lesion and histology AK Main eligibility criteria Patients with 4–15 grade I or II AKs on the face or scalp. Excluded patients had a history of cutaneous photosensitisation, porphyria, hypersensitivity to porphyrins, photodermatosis or inherited or acquired coagulation defects Patient characteristics % Male: 90 Age range: 34–89 yr The number of treated lesions per patient ranged from 4 to 15 Treated areas were the face or scalp, but not both in the same patient Concomitant treatment Not stated Authors Fowler and Zax (2002) 44 Linked publications162,163 Data source Full published paper. A summary of results of 2 trials with identical treatment protocols. Results for most outcomes were only available as combined data. Further data were obtained from drugs.com162 Country Not stated Language English Study design RCT No. of participants Total: Reported as being 243, across two trials – 116 in trial ALA-018, and 125 in trial ALA-019 (which totals 241) Intervention: ALA-018: 87 ALA-019: 93 Comparator: ALA-018: 29 ALA-019: 32 No. of recruiting centres Multicentre Follow-up period and frequency 1, 4, 8, and 12 wk, then FU at intervals of approximately 3 to 6 mth, up to 48 mth © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 191
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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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