APPENDICES - NIHR Health Technology Assessment Programme

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218 Appendix 14 Study details Population details Treatment details Results Interpretation Authors’ conclusions ALA–PDT may offer the best treatment option for Bowen’s disease. This study shows the potential of light fractionation for enhancing the response of the disease to ALA–PDT and illustrates the need for a larger, suitably powered trial to determine if the effect is statistically significant Brief study appraisal This was a small trial with unclear methods of randomisation and blinding. Treatment methods were reported but not all outcomes were detailed. This study shows the potential of PDT and its enhancement through light fractionation but would need confirmation, as the authors state, in an adequately powered trial Morbidity In the single illumination group, CR was seen in 22 patches (80%) at 12 mth. In the twofold-illumination group CR was seen in 22 patches (88%) (NS). Patients reported a 3-wk maximum healing time, which was not different between treatments QoL and return to normal activity Not assessed AEs All patients in both groups experienced some discomfort during treatment but all finished therapy. No SAEs were seen in either group. In the single-illumination group none of the patients complained of pain during treatment. In the twofold-illumination group five patients complained about pain in the treatment of six patches. Lidocaine without adrenaline was used in four patches Trial treatments ALA–PDT using a single illumination vs ALA–PDT with a twofold illumination Intervention Single Illumination: Surface scale or crusts were removed. 20% ALA, locally produced, was applied topically and left in place for 4 hr with a margin of 1 cm. A diode laser and light emitting diode provided illumination at a wavelength of 630 nm, 4 hr after ALA application at a dose of 75 J/cm2 Further PDT parameters were not reported Comparator Twofold illumination: As for single illumination except patches were light treated 4 and 6 hr after ALA application at doses of 20 and 80 J/cm2 , respectively, separated by a 2-hr dark interval. Each illumination was delivered at 50 mW/cm2 Type(s) of lesion and histology Bowen’s disease Main eligibility criteria Not stated Patient characteristics % Male: 43 Age range: 49–91 yr Mean age: 74 yr Mean lesion diameter: 14.5 mm (range 5–40 mm) Locations: Trunk 12, lower leg 11, hand 8, ear 7, upper leg 4, cheek and/or nose 3, eyelid 2, arm 1, frontal and/or temporal area 1, scalp 1 The sample included seven organ recipients Concomitant treatment Lidocaine, 2% without adrenaline was used if patients required it Authors de Haas et al. (2007) 69 Data source Full published paper Country The Netherlands Language English Study design RCT No. of participants Total: 40 (50 Bowen’s disease patches) Intervention: 25 lesions (participant no. not stated) Comparator: 25 lesions (participant no. not stated) No. of recruiting centres One Follow-up period and frequency 4 wk, then at 3 mth intervals up to 28 mth
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions A single course of verteporfin PDT showed treatment benefit for patients with multiple nonmelanoma skin cancers Brief study appraisal There was a lack of information on issues such as blinding and allocation concealment, and the authors did not present many results and population details by diagnosis. It is therefore difficult to make any reliable conclusions about the efficacy of verteporfin in patients with Bowen’s disease, particularly as they formed a small proportion of the overall number of lesions Morbidity At 6 mth, the histopathological response (i.e. no residual tumour) was 85% at 60 J/cm2 , 100% at 120 J/cm2 , and 50% at 180 J/cm2 QoL and return to normal activity Assessed but not reported for Bowen’s group AEs Assessed but not reported for Bowen’s group Trial treatments PDT at 60 J/cm2 vs PDT at 120 J/cm2 vs PDT at 180 J/cm2 Intervention PDT at 60 J/cm2 : 10 min intravenous infusion of 14 mg/m2 verteporfin followed 1–3 hr later by exposure to 60 J/cm2 of red light (688 ± 10 nm) from a nonthermal LED panel. The exposed area had a margin of 3–4 mm around the lesion. The irradiance delivered was 200 ± 40 mW/cm2 . Tumours re-treated at 3 mth if necessary (with dose increased to 18 mg/m2 ) Comparator PDT at 120 J/cm2 : See above 2nd comparator PDT at 180 J/cm2 : See above Type(s) of lesion and histology Superficial BCC, 277 lesions (66%); nBCC, 93 lesions (22%); Bowen’s disease, 34 lesions (8%); BCC unspecified 17 lesions (4%) Main eligibility criteria Patients with at least two biopsyproven superficial or nBCC or Bowen’s lesions Patient characteristics Not stated for Bowen’s group Concomitant treatment Oral analgesics for pain Authors Lui et al. (2004) 68 Data source Full published paper Countries Canada, USA Language English Study design RCT No. of participants Total: Not stated by diagnosis (34 lesions) Intervention: Not stated by diagnosis (27 lesions) Comparator: Not stated by diagnosis (one lesion) 2nd Comparator: Not stated by diagnosis (six lesions) No. of recruiting centres Four Follow-up period and frequency 6 wk, and 3, 6, 12, 18 and 24 mth © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 219
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166 Appendix 9 photodynamic therapy
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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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