APPENDICES - NIHR Health Technology Assessment Programme

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230 Appendix 15 Study details Population details Treatment details Results Interpretation Authors’ conclusions The study found no difference in short-term efficacy between ALA–PDT and MAL–PDT, so both can be equally recommended as photosensitisers Brief study appraisal This pilot study blinded both patients and outcome assessors. However, there was no mention of a power calculation and the sample size was very small; a larger study would have been more informative, particularly on differences in pain scores Morbidity There was no statistically significant difference in incomplete clearance rates [6/22 (27%) ALA vs 6/21 (29%) MAL, p = 0.92] QoL and return to normal activity Not assessed AEs Average intensity of pain did not differ significantly between groups (1st treatment: VAS = 4.4 for ALA vs 2.8 for MAL, p = 0.09, 2nd treatment: VAS = 4.8 for ALA vs 3.9 for MAL, p = 0.4), nor did character of pain. Most pain was described as being burning or stinging Trial treatments PDT with 5-aminolevulinate (ALA–PDT) vs PDT with methyl aminolevulinate (MAL– PDT) Intervention ALA–PDT: All tumour tissue above skin level was removed by curettage (with ethyl chloride spray anaesthetic). The visible tumour, plus 5-mm margin, was covered in a layer of 20% ALA cream (around 2 mm thick) and polyurethane and opaque dressings were applied. After 3 hr the area was cleaned and illuminated with light of 600–730 nm (from metal halogen source) with an intensity of 100 mW/cm2 giving a total dose of 75 J/cm2 . After illumination the area was covered with a light protective dressing for 1 d Procedure repeated after 7 d (but without debulking) Comparator MAL–PDT: Same methods as for PDT with 5-aminolevulinate group, except 16% methyl aminolevulinate cream was used instead of 20% ALA Treatment intention Curative Type(s) of cancer and histology Nodular primary BCC Main eligibility criteria Patients with nodular primary BCC located anywhere on skin except periocular area and hairy scalp, with a clinical diameter smaller than 20 mm. Pigmented BCCs and patients with more than five BCCs were excluded, as were patients with porphyria, contraindications to surgery, or hypersensitivity to daylight or to either of the creams Patient characteristics % Male: 62 Age range: 39–87 yr Mean age: 68 yr Most tumours were less than 10 mm in diameter Concomitant treatment Topical emollient for pain Authors Kuijpers et al. (2006) 84 Data source Full published paper Country The Netherlands Language English Study design RCT (between-participant comparison) No. of participants Total: 43 BCCs in 39 patients Intervention: 22 BCCs Comparator: 21 BCCs No. of recruiting centres One Follow-up period and frequency 8 wk
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 No clinically relevant comparator treatment was used, 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 BCC Morbidity At 6 mth, the histopathological response (i.e. no residual tumour) was: nBCC: 76% at 60 J/cm2 , 82% at 120 J/cm2 , and 100% at 180 J/cm2 ; superficial BCC: 63%, 80%, and 97%; BCC not specified: 0%, 56% and 75% There was a trend indicating a better response with a higher light dose (p = 0.06) QoL and return to normal activity Reported by light dose rather than tumour type AEs Reported by light dose, rather than by tumour type 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 non-thermal LED panel. The exposed area included 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 Treatment intention Curative Type(s) of cancer 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 BCC only (study also included SCC) but overall: Average tumours treated per patient = eight Age range: 22–79 yr Mean age: 55 yr Most patients had Fitzpatrick skin type II or III Concomitant treatment Oral analgesic drugs for pain Authors Lui et al. (2004) 68 Data source Full published paper Countries Canada, USA Language English Study design RCT (betweenparticipant comparison) No. of participants Total: Not stated by diagnosis (387 lesions classified as BCC) Intervention: Superficial BCC 120 lesions; nBCC 47 lesions; BCC (not specified) zero Comparator: Superficial BCC 77 lesions; nBCC 30 lesions; BCC (not specified) nine 2nd Comparator: Superficial BCC 80 lesions; nBCC 16 lesions, BCC (not specified) eight No. of recruiting centres Four Follow-up period and frequency FU at 6 wk, and 3, 6, 12, 18 and 24 mth (optional beyond 6 mth) © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 231
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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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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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