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256 Appendix 17 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT with porfimer solution has overall equal efficacy to Nd:YAG laser thermal ablation for palliation of dysphagia in oesophageal cancer, and equal or better objective tumour response rate. Temporary photosensitivity is a limitation, but PDT is carried out with greater ease and is associated with fewer acute perforations than Nd:YAG laser therapy Brief study appraisal The methods were generally well-described though a few features were not reported. It may have been useful to gauge patient/investigator opinion of ease of treatment and importance of photosensitivity to QoL to inform the conclusions Mortality Not assessed Morbidity Dysphagia grades significantly improved from baseline at 1 wk (PDT –0.73 vs Nd:YAG –0.90) and 1 mth (PDT –0.75 vs Nd:YAG –0.68) with both treatments (ns difference between treatment groups). Objective tumour response (responders: patients with CR or PR) was 44% PDT vs 48% Nd:YAG (ns) at 1 wk and 32% PDT vs 20% Nd:YAG at 1 mth (p < 0.05). Data was obtained from 80% patients at 1 wk and 60% at 1 mth. Subgroup analyses showed ns differences between groups but there was a trend in favour of PDT for objective tumour response rates in the upper and lower third of the oesophagus, tumours > 10 cm and in patients that received prior therapy. There was no difference between groups for patients with squamous cell cancer and adenocarcinoma QoL and return to normal activity Not assessed AEs Significantly more PDT patients had an AE (92% vs 82%, p < 0.05). Sunburn (19% PDT vs 0%), nausea (8% vs 2%), fever (16% vs 5%) and pleural effusion (10% vs 2%) were significantly greater for PDT and oesophageal perforation greater for Nd:YAG (1% vs 7%) p < 0.05). All PDT patients were photosensitive for 1–2 mth, none severe. Treatment-related respiratory insufficiency occurred in 3% PDT (vs 1%). Severe AEs were equal overall for both treatments Resource use Not assessed Trial treatments PDT vs Nd:YAG laser Intervention PDT: 40–50 hr after single intravenous injection with Ps (2 mg/kg bw), illumination by red light (630 nm) provided by a continuous wave argon pumped-dye laser and delivered via an optical quartz fibre with a cylindrical diffusing tip (400 mW/cm, total dose 300 J/cm). After 2–3 d patients were re-endoscoped to debride the necrotic tumour and residual tumour could be treated with a 2nd application of laser light (same dose). A maximum of three courses at 1-mth intervals was permitted Comparator Nd:YAG laser therapy: A laser power setting of 15–90 W and pulse duration of 0.5–4.0 s was used (delivered with either contact or non-contact technique via quartz fibres). Each session ended when the endoscopist thought maximum achievable benefit or maximum patient tolerance was reached. Repeat sessions could be given if initial response was deemed insufficient (the course was deemed complete when the investigator believed dysphagia had been palliated or further therapy would be futile) Treatment intention Palliative Type(s) of cancer and histology Oesophageal carcinoma Main eligibility criteria Patients with a biopsy-proven oesophageal malignancy and that were too debilitated for, refused, failed to respond to or had a recurrence following chemotherapy, radiation therapy or surgery were eligible for inclusion. Also patients with SCC or adenocarcinoma, and that were symptomatic, had malignancy-caused dysphagia to solid foods and a Karnofsky status of at least 30% were eligible. Prior therapy was required to be terminated at least 4 wk before randomisation. Bronchoscopy was required for tumours at or above the level of the carina. Patients with involvement of the tracheobronchial tree and those that had prior treatment for oesophageal carcinoma with PDT or Nd:YAG laser were excluded. Concurrent radiation and chemotherapy were not permitted Patient characteristics % Male: 72 Median age: PDT 68 yr; Nd:YAG 72 yr Median Karnofsky performance status: 80% Prior therapy: 45% Median tumour length: PDT 6 cm; Nd:YAG 5 cm Adenocarcinoma 51%, the rest had SCC Concomitant treatment Not stated Authors Lightdale et al. (1995) 112 Data source Full published paper Country USA Language English Study design RCT No. of participants Total: 236 (218 treated) Intervention: 118 (110 treated) Comparator: 118 (108 treated) No. of recruiting centres 24 Follow-up period and frequency FU at 1 wk, then 1, 2, 3 and 6 mth 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 Combined PDT/HBO represents a new approach in the treatment of oesophageal and cardial cancer, which appears to have enhanced the efficacy of PDT Brief study appraisal This was a small pilot study that, despite not being randomised, does seem to have achieved reasonable comparison groups. The authors comment that randomisation was not possible due to the variable availability of the oxygen chamber. The conclusions are reasonable but the study would have benefited from blinded outcome assessors Mortality Median survival after PDT was 8.7 mth vs 13.8 mth for PDT/ HBO (p = 0.021) Morbidity At 3 mth, dysphagia score had decreased in both groups but there was no significant difference between treatments (p = 0.43). At 3 mth, mean decrease in stenosis was 5.6 mm in the PDT group vs 6.3 mm PDT/HBO, p = 0.065. Mean decrease in tumour length was 2 cm PDT vs 2.8 cm PDT/HBO, p = 0.002 QoL and return to normal activity A semi-solid diet was possible in all patients after PDT or PDT/HBO AEs No major complications related to PDT, HBO and photosensitisation, and no barotrauma of the ear or lung or sunburn was observed. Minor complications included: postinterventional odynophagia (eight PDT vs nine PDT/HBO), fever up to 39° (five vs nine) and chest pain for 1 or 2 d (five vs nine). Six oesophagotracheal fistulas were found in two cases (PDT at 5 and 17 mth) and four cases (PDT/HBO at 4, 7, 14 and 24 mth). Stenting with coated, self-expandable stents was performed in one PDT patient at 16 mth and two PDT/HBO patients at 14 and 17 mth. One patient had haemorrhage of the tumour 18 mth after PDT/HBO Resource use Not assessed Trial treatments PDT vs PDT under HBO Intervention PDT: Photosan-3 (2 mg/kg) was administered intravenously. After 48 hr, PDT, using a fibre with a 1-cm tip radial light-diffusing cylinder, was inserted using an endoscope. Illumination dose was 300 J/cm of fibre, 630 nm applied by a KTP-Nd:YAG laser. Treatment was under shortterm intravenous anaesthesia. 2–3 d after PDT, endoscopy was repeated, and necrotic tissue removed mechanically if necessary. Treatment could be repeated after 3 mth if necessary but most patients received one session Comparator PDT under HBO (PDT/HBO): As for PDT but under HBO at a level of 2 ATA in a hyperbaric chamber. Oxygen was administered with the Scuba valve, transcutaneous Po levels 2 were 500–750 mmHg. Before HBO, patients had an ear, nose and throat check-up Treatment intention Palliative Type(s) of cancer and histology Advanced cancer of the upper gastrointestinal tract Main eligibility criteria It appeared that patients with advanced cancer of the upper gastrointestinal tract who were not eligible for resection treatment due to poor performance status, functional and/or anatomic inoperability, and/or anatomic inoperability, and/or refusing surgery were eligible for inclusion Patient characteristics % Male: 81 Age range: 46–87 yr Mean age: 67.3 yr Most patients’ cancers were judged to be stage III, dysphagia scores varied across levels 2, 3 and 4 and no significant differences at baseline were found. Tumours were SCC in 25 cases, adenocarcinoma in 25 cases. Further patient characteristics were reported Concomitant treatment Before PDT, 12 (seven in PDT, five in PDT/ HBO) patients underwent dilatation and retrograde Nd:YAG laser disobliteration Authors Maier et al. (2000) 115 Data source Full published paper Country Austria Language English Study design Non- RCT No. of participants Total: 52 Intervention: 23 (PDT) Comparator: 29 (PDT under HBO) 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. ATA, atmosphere absolute. 257
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APPENDICES - NIHR Health Technology Assessment Programme

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