APPENDICES - NIHR Health Technology Assessment Programme

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258 Appendix 17 Study details Population details Treatment details Results Interpretation Authors’ conclusions Combined PDT/HBO represents a new approach in the treatment of oesophageal and cardial cancer which appears to have enhanced the efficiency of PDT Brief study appraisal This study was not randomised (and so may have been subject to bias) and included a fairly small number of patients. The authors did though acknowledge that definitive conclusions could not be drawn based on these results. This publication appears to be the same study as a report of a pilot study 211 , although the authors were not Trial treatments PDT vs PDT/HBO Intervention PDT: HpD given intravenously (2 mg/kg) and camouflage skin protection used for 2 wk, then sunblock for 10 wk. PDT given 48 hr after sensitisation with a fibre (1-cm tip, radial light diffusing cylinder) inserted through the biopsy channel of the endoscope (several placements were necessary). Light dose was 300 J/cm, 630 nm applied with a KTP-Nd:YAG laser with DYE box. Treatment given under short-term anaesthesia. Endoscopy was repeated 2–3 d after PDT and necrotic tissue removed mechanically if necessary. Prior to PDT, dilatation and retrograde Nd:YAG was necessary in 15 cases Comparator PDT/ HBO: As for PDT except patients had ear, nose and throat check-up, then PDT given under HBO (2 atmospheres) in a walk-in hyperbaric chamber explicit about this Mortality Median overall survival with PDT was 7 mth (vs 12 mth in PDT/HBO group), p = 0.0098. 12-mth survival with PDT was 25% vs 52% with PDT/HBO Morbidity At 3 mth, stenosis decreased in both groups by 6 mm In the PDT group median tumour length decrease was 2 cm vs 3 cm in the PDT/HBO group, p = 0.0002 At 3-mth FU (or last FU in case of death) in the PDT group dysphagia score could be lowered by one level in eight cases (vs nine) and two levels in 23 cases (vs 33) (and in the PDT/HBO group it could be lowered by three levels in two cases); this significantly favoured PDT/HBO (p = 0.0064). No recurrent dysphagia was observed at 3-mth FU for either group QoL and return to normal activity At least a semi-solid diet was possible in all patients after either treatment AEs There were no major postinterventional complications or skin photosensitisation related to either treatment. No barotrauma was observed. Minor complications included: odynophagia (PDT group 6 vs PDT/HBO 8); fever up to 39° in the afternoon of the interventional day, one in PDT vs three in PDT/HBO); chest pain for 1 or 2 d (four in PDT vs seven in PDT/HBO). 30-day mortality was 0%. Six oesophagotracheal fistulas in two patients were found (PDT, two cases; PDT/ HBO four cases) Resource use Hospitalisation in both groups was 3–9 d (median 4.9 d) Treatment intention Not stated Type(s) of cancer and histology Advanced oesophageal carcinoma Main eligibility criteria Patients that were not eligible for resection treatment due to significant comorbidity were included Patient characteristics % Male: 80 Mean age: PDT alone, 67 yr; PDT/HBO 67.5 Age range: 46–87 yr Cancer stage: III, 59; IV, 16 Dysphagia score: level 2, 23; level 3, 37; level 4, 15. 40 SCC, 35 adenocarcinoma Further patient characteristics were reported Concomitant treatment Not stated Authors Maier et al. (2000) 116 Linked publications211 Data source Full published paper Country Austria Language English Study design Non-RCT No. of participants Total: 75 Intervention: 31 Comparator: 44 No. of recruiting centres One Follow-up period and frequency FU after 1 mth, then every 3 mth
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT has been shown to be an effective palliative treatment of advanced oesophageal cancer. However, proper patient selection is necessary to prevent serious complications Brief study appraisal A sizeable proportion of patients in each group were pre-treated with Nd:YAG, which did not appear to be accounted for in the analysis. This trial appears to have contained four separate arms, although this was poorly described. Patients in good/ fair condition received a slightly different treatment protocol. These limitations make it difficult to evaluate reliability of the authors’ conclusions Mortality Mean survival was 5.6 mth for brachytherapy; 7.7 mth brachytherapy and external beam irradiation; 6.3 mth PDT brachytherapy; 13 mth PDT, brachytherapy and external beam irradiation. There was a significant difference with PDT* (p = 0.0129) and external beam irradiation* (p = 0.0001). This was biased, as groups without external beam irradiation contained patients that died before entering the irradiation regimen. (Authors’ comment.) *It was unclear which patient groups these results referred to Morbidity Dysphagia score improved in all patients by one to three levels and was significantly greater in the PDT group (p = 0.0003). The mean increase in opening diameter of tumour-related stenosis was significantly greater in the PDT group with or without external beam irradiation than in either of the brachytherapy conditions QoL and return to normal activity There were no significant differences between the two groups in terms of Karnofsky performance status scores at 3 mth, p = 0.28 AEs Major complications occurred in 9% (11/119) of patients, including oesophageal perforation after brachytherapy, severe haemorrhaging 3 d after PDT, spontaneous perforation of distal oesophagus with oesophagomediastinopleural fistula and concurrent pleural emphysema 5 mth after PDT, tracheo-oesophageal or tracheobronchial fistula. Due to strictures, dilation was necessary after PDT (four patients) and Nd:YAG (45 patients). After PDT 28 patients reported odynophagia for 2–5 d Resource use Not assessed Trial treatments PDT and brachytherapy vs brachytherapy alone Intervention PDT and brachytherapy: Intravenous haematoporphyrin was administered (mean 1.5 injections/patient) (2 mg/kg), after 48 hr PDT treatment using a fibre with 2-cm radial light-diffusing cylinder inserted through biopsy channel of an endoscope (dose 300 J/cm fibre, 630 nm applied by a KTP-Nd:YAG laser with DYEbox). 2–3 d after PDT, endoscopy repeated and necrotic tissue removed. Endoscopy was performed after 1 mth, then every 3 mth. PDT was not repeated within 3 mth. Iridium-192 brachyradiotherapy was given by insertion of the afterloading catheter. 5 Gy per session was given, patients received one to four sessions in total depending on endoscopic findings and dysphagia, with 3–7 d between sessions. This process was carried out under short-term intravenous anaesthesia, combined with topical anaesthesia with supported breathing. In 25 patients with Karnofsky score of > 80 (fair condition) treatment was completed by external beam irradiation using the multiple field technique to deliver mean dose of 44 Gy Comparator Brachytherapy: Iridium-192 brachyradiotherapy was given by insertion of the afterloading catheter. 5 Gy per session was given, patients received one to four sessions in total depending on endoscopic findings and dysphagia, with 3–7 d between sessions. This process was done under shortterm intravenous anaesthesia, combined with topical anaesthesia with supported breathing. In 17 patients with Karnofsky score of > 80 (fair condition) treatment was completed by external beam irradiation using the multiple field technique to deliver mean dose of 44 Gy Treatment intention Palliative Type(s) of cancer and histology Advanced oesophageal carcinoma Main eligibility criteria Patients who were not eligible for resection due to tumour involvement of the adjacent tissue, poor performance status plus inoperable status as a result of comorbidity, refusal of surgical intervention, or a combination of these, were included Patient characteristics % Male: 81 Mean Age: Men, 67 yr; women 65 yr Age Range: 27–93 yr Cancer stage: III, 80; IV, 39. 68 SCC and 51 adenocarcinoma Further patient characteristics were reported Concomitant treatment Prior to therapy 21 patients required initial dilatation and tumour obliteration with Nd:YAG Authors Maier et al. (2000) 117 Data source Full published paper Country Austria Language English Study design Non- RCT No. of participants Total: 119 Intervention: 44 (PDT and brachyradiotherapy) Comparator: 75 (brachyradiotherapy) No. of recruiting centres Not stated Follow-up period and frequency FU at 1 mth, then every 3 mth © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 259
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166 Appendix 9 photodynamic therapy
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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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