APPENDICES - NIHR Health Technology Assessment Programme

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284 Appendix 21 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT is effective and safe for the treatment of advanced nasal pharyngeal cancer and the management of nasal obstruction Brief study appraisal This small pilot study provided no details on randomisation, blinding and other study quality parameters raising questions about the validity of the results. Treatment details were well described. It does not appear to have led on to a larger study, though the authors rightly stated that further investigation was needed Mortality Not assessed Morbidity Overall clinical response was statistically significantly better with PDT than chemotherapy (p = 0.001). No patients achieved CR. The PDT group had more patients with a significant response (i.e. 50% reduction for 1 mth, 12 vs 2). In those patients with nasal obstructions PDT produced more effective debulking (p = 0.04) (subgroup of 16 patients, 7/8 improved vs 2/8) QoL and return to normal activity PDT group had a statistically significant greater improvement in Karnofsky score (p = 0.02). PDT group increased from 45 to 70 vs chemotherapy group increased from 40 to 50 AEs All PDT related adverse effects and reactions were tolerable. Treatment to the laryngopharynx area resulted in slight pain and increased nasal cavity secretion – resolved in 3–5 d One case of severe laryngopharynx swelling and pain. Resolved with treatment 1 wk later, may be related to light exposure One case of photosensitivity dermatitis after accidental exposure to daylight. Resolved after treatment, 1 wk later One case of skin pigmentation, no treatment required Trial treatments PDT vs Chemotherapy (cisplatin and 5-FU) Intervention Intravenous Photofrin of 2 mg/kg. Local anaesthetic (lidocaine) before light (630 nm) at 200–300 J/cm from a diode laser through a cylindrical diffuser (1–5 cm) 48 hr after injection. Light was applied to one to three overlapping segments for 12 min per segment. Segments had at least a 0.5-cm margin beyond the lesion. After 48-hr necrotic tissue removed by biopsy forceps and newly exposed lesions were re-treated after cleaning. Cleaning was repeated when necessary. Patients asked to avoid sunlight for 4–6 wk after treatment. Maximum number of sessions was not stated Comparator Cisplatin 80 mg/m2 and 5-FU 500 mg/m2 , both divided into five. Each cycle lasted 4 wk. Two cycles were given Treatment intention Not stated, appears palliative Type(s) of cancer and histology Nasopharyngeal carcinoma Main eligibility criteria Patients who had relapsed and who had failed radiotherapy Patient characteristics % Male: 80 Age range: 28–72 Mean age: 54 yr Cancer stage: All stage IV and had local relapse. All had prior (failed) radiotherapy; some also had prior chemotherapy, 6–12 mth before trial treatment Concomitant treatment Antivomiting treatment for chemotherapy group. Chinese herbs (unspecified) Authors Li et al. (2006) 141 Data source Full published paper Country China Language English Study design RCT No. of participants Total: 30 Intervention: 15 Comparator: 15 No. of recruiting centres Not stated Follow-up period and frequency FU at 1, 3 and 6 mth
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions Intraoperative PDT in patients with stages I and II laryngeal cancer could be effective for preventing recurrence and metastasis of tumours Brief study appraisal This study used comparator treatments such that the results offer little insight to how PDT compares to other treatments adjunctive to surgery. The study also examined few outcomes and there was sparse reporting of methods, patient characteristics and results Morbidity After 3 yr there was recurrence in one patient (2%) and no cases of metastasis in the PDT group, four cases of recurrence (8%) in the laser group and one case of metastasis, and five cases of recurrence (10%) and two cases of metastasis in the Surgery-alone group QoL and return to normal activity Not assessed AEs PDT group: Some patients had oedema of laryngeal mucous membrane and one patient had a small haemorrhage. Surgery-alone group: One patient had a small haemorrhage. Both haemorrhages were managed by conservative treatment Trial treatments Surgery/ intraoperative PDT vs Surgery/ intraoperative PDT without laser vs Surgery alone Intervention Cordectomy with local anaesthetic, followed by administration of 0.4% solution of methylene blue photosensitiser. A He-Ne laser of wavelength 633 nm emitting at 25–30 mW/cm2 for 5 min was used. Further PDT parameters were not reported Comparator Cordectomy with local anaesthetic followed by laser only (same parameters as PDT group) 2nd comparator Cordectomy with local anaesthetic only Treatment intention Curative Type(s) of Cancer and Histology Planocellular cancer of larynx Main eligibility criteria Not stated Patient characteristics Cancer stage: Stage Ib, 79; stage IIa, 66. All cancers were of middle localisation. No further characteristics were reported Concomitant treatment Not stated Authors Loukatch et al. (1995) 142 Data source Abstract Country Ukraine Language English Study design Non-RCT No. of participants Total: 145 Intervention: 42 Comparator: 51 2nd Comparator: 52 No. of recruiting centres Not stated Follow-up period and frequency 3 yr © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 285
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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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148 Appendix 6 carcinomas: 5 years
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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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182 Appendix 12 as salvage treatmen
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184 Appendix 12 63. Lorenz KJ, Maie
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186 Appendix 12 107. Biel MA. Photo
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188 Appendix 13 Study details Popul
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APPENDICES - NIHR Health Technology Assessment Programme

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