APPENDICES - NIHR Health Technology Assessment Programme

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228 Appendix 15 Study details Population details Treatment details Results Interpretation Authors’ conclusions There is a significant increase in the CR rate of PDT using two-light fraction illumination scheme compared with a singleillumination scheme Brief study appraisal Although treatment methods were very well described, study design details on issues such as randomisation, blinding, and dropouts (were 154 or 155 patients treated?) were not provided, making it difficult to assess the reliability of the results Morbidity CR of lesions was significantly greater using fractionated illumination compared with single illumination (at 1 yr, 97% vs 89%, p = 0.002). The results were very similar when analysis was undertaken on a subgroup of histologically proven BCCs. 10/262 (4%) lesions failed to respond, or recurred, in the fractionatedillumination group compared with 32/243 (13%) in the singleillumination group (p = 0.0002). There were no significant differences in response rates, within each illumination group, for the different light sources used QoL and return to normal activity Assessed but not reported AEs 5/100 (5%) patients required pain relief in the single illumination group compared to 15/55 (27%) patients in the fractionated illumination group Trial treatments Fractionated illumination PDT vs single-illumination PDT Intervention Fractionated illumination PDT: Crusts and scaling were gently removed using a disposable curette before ALA application. Illumination using doses of 20 and 80 J/cm2 (at 50 mW/cm2 ) delivered 4 and 6 hr after administration of 20% ALA ointment (containing 2% lidocaine) with a 1-cm margin. One of three different light sources were used on each lesion (a 630-nm diode laser, coupled into a 600-µm optical fibre and using a combination of lenses for uniform fluence rate; a light-emitting diode 633 nm with a bandwidth of 20 nm; or a 2nd broadband source with an output of between 590 and 650 nm), with a margin of at least 5 mm. A light-protective bandage (including aluminium foil) was used to provide the 2-hr dark interval between fractions. Participants were instructed to stay out of the cold Comparator PDT with placebo cream: Patients received two cycles (1 wk apart) of placebo cream PDT. There was surface debridement and slight lesion debulking prior to PDT. BCC with partial clinical response at 3 mth were re-treated. Further parameters were not reported Treatment intention Curative Type(s) of cancer and histology Primary superficial BCC Main eligibility criteria Not stated Patient characteristics Age range: 31–83 yr Mean age: 57 yr All participants were Caucasians Concomitant treatment Paracetamol, lidocaine (without adrenaline) or bupivacaine if required Authors de Haas et al. (2006) 83 Data source Full published paper Country The Netherlands Language English Study design RCT (between-participant comparison) No. of participants Total: 154 (505 lesions) Intervention: 55 (262 lesions) Comparator: 100 (243 lesions) No. of recruiting centres One Follow-up period and frequency FU four times a year in 1st year, then twice yearly. Patients tending to develop more lesions were seen more frequently. Minimum FU period was 1 yr, maximum FU period was 5 yr
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 good alternative to existing therapies, particularly in areas where an excellent cosmetic outcome is crucial Brief study appraisal Limited reporting of methods and results makes meaningful interpretation difficult. No details were reported on who assessed cosmetic outcomes, and whether outcome assessors were blinded. Outcomes not always reported for both groups, or broken down by group Morbidity At 6 mth, histological evaluation there were no signs of malignancy in 73% of the active PDT group vs 21% in the placebo PDT group (p < 0.001) QoL and return to normal activity Cosmetic outcome rated as excellent or good in 95% of the active PDT patients AEs There were no treatmentrelated serious or systemic AEs. Burning, stinging, pain, and erythema were transient, and graded as mild or moderate Trial treatments PDT (methyl aminolevulinate) vs PDT (placebo cream) Intervention Lesions 1st prepared by debridement/debulking. PDT with 160 mg/g of methyl aminolevulinate cream and 3 hr of red light (570– 670 nm) with a total light dose of 75 J/cm2 . Treatment repeated after 7 d. Lesions with PR at 3 mth were retreated. Further PDT parameters were not reported Comparator As for active PDT group, but using placebo cream Treatment intention Curative patients with histologically confirmed nBCC Type(s) of cancer and histology nBCC Main eligibility criteria Patients with histologically confirmed nBCC Patient characteristics Not stated Concomitant treatment Not stated Authors Foley et al. (2003) 77 Data source Abstract Country Australia Language English Study design RCT (betweenparticipant comparison) No. of participants Total: 66 Intervention: 33 Comparator: 33 No. of recruiting centres Not stated Follow-up period and frequency Not clear, but appeared to be at least 6 mth © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. nBCC, nodular basal cell carcinoma. 229
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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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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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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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