APPENDICES - NIHR Health Technology Assessment Programme

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264 Appendix 17 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT is safe and effective for advanced oesophagocardiac cancer. Its therapeutic effect can be further improved when combined with local chemotherapy Brief study appraisal This study was poorly reported (e.g. method of randomisation, whether ITT analysis was used) but most importantly it appears that after over 40 patients had been treated, interim analysis was carried out and all subsequent patients were treated with combined PDT and 5-FU. These analyses were not further reported. Given this shift from an RCT to experimental without a comparator it is difficult to determine the reliability of the study results overall The authors’ conclusions do not follow from the results reported Mortality Mean survival time was 8.9 mth with PDT alone compared with 15.1 mth for PDT and 5-FU (p < 0.01) Morbidity The rate of dysphagia remission was 87% for PDT compared with 99% with PDT and 5-FU (p < 0.05). Differences in pharyngeal pain and weight loss were not significant. With PDT alone one patient achieved complete remission (vs five with combined therapy, p < 0.05), eight significant remission (vs 36) and five no remission (vs nine). With combined therapy 48 patients also achieved minor remission QoL and return to normal activity Not assessed AEs Subternal pain due to oesophageal mucosa injury and gastroesophageal reflux 1–2 d after treatment was reported by seven patients in PDT only and eight patients in combination treatment Eight patients in total accidentally exposed themselves to sunlight and developed discoloration of the skin No oesophageal stenosis or perforation reported in either group Resource use Not assessed Trial treatments PDT vs PDT with 5-FU Intervention PDT: After intravenous injection of the photosensitiser PSD-007 (photocarcinorin) (3–5 mg/kg bw) and patients were kept in the dark. Irradiation was performed at 24 and 48 hr with either 630-nm copper vapour pumped-dye laser or 632.8 nm high power He-Ne laser (total dose 200–400 J/cm fibre length, median 300 J/cm). This was delivered by cylindrical diffusers under endoscope assistance. Irradiation was carried out in one to four segments (with slight overlap between each segment) depending on lesion length and diffuser. Treatment could be repeated after 1 mth unless evaluation showed effectiveness or symptoms were remitted. Patients were advised to avoid sunlight exposure for over 1 mth Comparator PDT with 5-FU: As for PDT but in addition, before irradiation, 200–500 mg 5-FU was locally injected into tumour tissue under endoscopic guidance. Before injection the extent of the lesions was confirmed. Most patients received four to eight injections per tumour Treatment intention Palliative Type(s) of cancer and histology Advanced oesophagocardiac carcinoma Main eligibility criteria Biopsy proven advanced oesophageal carcinoma Patient characteristics % Male: 79 Age range: 40–81 yr Median age: PDT 58; PDT with 5-FU 62 Cancer stage: Stage II 84; stage III 53; stage IV 3 Concomitant treatment Not stated Authors Zhang et al. (2007) 113 Data source Full published paper Country China Language English Study design RCT No. of participants Total: 140 Intervention: 42 Comparator: 98 No. of recruiting centres Not stated; appears to be two centres in China Follow-up period and frequency FU at 1 mth. Over 70% patients were followed up for 12–36 mth
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. Appendix 18 Lung cancer data extraction 265
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140 Appendix 6 18. Biel MA. Photody
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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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APPENDICES - NIHR Health Technology Assessment Programme

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