APPENDICES - NIHR Health Technology Assessment Programme

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254 Appendix 17 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT can relieve oesophageal obstruction from squamous cell and adenocarcinoma and is an alternative to Nd:YAG thermal necrosis with a longer duration of response. However, PDT requires patient precautions to minimise skin photoreactions Brief study appraisal This was a small but well-conducted and reported study despite the apparent lack of blinding of outcome assessors. The analyses adjusted for confounding variables, and the significant benefits in favour of PDT could be considered as promising Mortality Mean survival was not significantly different between PDT and Nd:YAG (145 vs 128 d, p = 0.419) Morbidity At 1 mth PDT was associated with a greater increase in dietary performance (p = 0.006), Karnofsky performance status (p < 0.001) and oesophageal grade (p = 0.002) compared with Nd:YAG. Mean duration of response with PDT was 84 d vs 53 for Nd:YAG, p = 0.008. The difference in dietary levels at 1 wk and weight change between treatment groups was ns. CR was seen in two PDT patients vs one QoL and return to normal activity Not assessed AEs In the randomised trial patients complications were relatively few: fistula (one PDT patient vs two), stricture (zero vs two), skin photoreaction (four vs zero), fever (five vs one) and luminal plugging (five vs five) Resource use Not assessed Trial treatments PDT with DHE vs Nd:YAG laser Intervention PDT: IV DHE was given (2 mg/kg bw), then illumination with an argon pumped-dye laser. 630 ± 2 nm (300 J/cm) red light was delivered by cylinder-diffusing fibres, and tumour segments were treated sequentially in a retrograde fashion. Power density was 400 mW/cm fibre tip. Tissue dose was calculated from light dose delivered and surface area exposed, estimated from segmental luminal diameter. A 2nd dose could be given if necessary (13 patients). Patients advised to restrict sun exposure for at least 30 d post injection. If there was a recurrence of tumour obstruction another course of PDT was given if 1 mth had elapsed since DHE injection Comparator Nd:YAG: Standard technique was used at 90 W in a retrograde fashion. Laser pulses were delivered through quartz fibres (bare or coaxial air flow). Therapy was delivered every 2–4 d until luminal patency was achieved. Most patients required two sessions Treatment intention Palliative Type(s) of cancer and histology Oesophageal cancer Main eligibility criteria Patients with dysphagia caused by biopsyproven oesophageal malignancy that were not suitable for, had refused or failed surgery, radiotherapy and chemotherapy were eligible for inclusion. Prior therapy had to have ended at least 1 mth before enrolment. Exclusion criteria were: tracheal involvement by bronchoscopy and Karnofsky performance status < 30 Patient characteristics % Male: 62 Age range: 42–87 yr Mean age: 70 yr (PDT) 73yr Nd:YAG Mean Karnofsky status for both groups was around 73–74 Overall, 60% of tumours were squamous and 40% were adenocarcinoma. Most patients had some kind of prior therapy Concomitant treatment Not stated Authors Heier et al. (1995) 114 Data source Full published paper Country USA Language English Study design RCT No. of participants Total: 42 Intervention: 22 Comparator: 20 No. of recruiting centres Not stated Follow-up period and frequency FU at 1 wk, then once per month. CT every 3 mth DHE, dihaematoporphyrin ethers; ns, not significant.
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT when indicated as a salvage therapy in patients with local failure after CRT for oesophageal cancer tended to be less effective than when indicated as a 1st-line treatment. Moreover, severe complications, including death-related procedures were significantly more frequent in patients treated after prior CRT Brief study appraisal Few methodological and patient details were reported in this abstract of a small study so the reliability of the conclusions is unclear. The authors appear to have drawn conclusions at odds with the statistical test results The authors’ conclusions do not follow from the results reported Mortality Not assessed Morbidity 16/22 lesions (73%) were successfully treated in the primary intent group vs 8/15 (53%) after failed CRT, p = 0.3. There was no difference in recurrence rate between groups (9 vs 14%, ns) QoL and return to normal activity Not assessed AEs Severe complications were 10% in the primary intent PDT group vs 50% for failed CRT (p = 0.015) (two strictures requiring endoscopic dilation vs two perforations and five strictures requiring dilation respectively). Death rate directly related to PDT was 0% in primary intent patients vs 14% for failed CRT (ns) Resource use Not assessed Trial treatments PDT in patients treated in primary intent vs PDT in patients treated with PDT after local failure of definitive CRT Intervention Primary intent PDT: After IV Photofrin (2 mg/kg), illumination with a dye laser between 48h. The mean number of PDT sessions was 1.18. Control endoscopies with routine biopsies were planned 6–8 wk after PDT. No further details were reported Comparator PDT after failed CRT: As for primary intent PDT except mean number of PDT sessions was 1.33 Treatment intention Curative Type(s) of cancer and histology Early stage oesophageal cancer Main eligibility criteria Not stated Patient characteristics Not reported in detail, paper states no significant differences between groups. Median tumour length 2cm Concomitant treatment Not stated Authors Lecleire et al. (2008) 111 Data source Abstract Country Not stated Language English Study design Non-RCT No. of participants Total: 35 (37 lesions) Intervention: 21 (22 lesions) (primary intent PDT) Comparator: 14 (15 lesions) (PDT indicated after local failure of CRT) No. of recruiting centres Not stated Follow-up period and frequency Median FU 15 mth © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. CRT, chemoradiotherapy; ns, not significant. 255
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APPENDICES - NIHR Health Technology Assessment Programme

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