APPENDICES - NIHR Health Technology Assessment Programme

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260 Appendix 17 Study details Population details Treatment details Results Interpretation Authors’ conclusions Despite the limitations of a non-randomised study, photosensitisation with Photosan seems to be more effective in PDT of advanced oesophageal carcinoma compared with ALA Brief study appraisal The conclusions that could be drawn were limited as this was a small, non-randomised study. Baseline characteristics were largely similar apart from M stage and the authors’ cautious conclusions appear reliable. This study appears to have been published twice (see ref. 120) with Photosan being described as HpD. The patients, treatments and results appear to be identical, therefore only one study has been data extracted Mortality Median survival for ALA group was 8 mth vs 9mth, p = 0.44 (Kaplan–Meier survival curve in paper) Morbidity At 1 mth, there was significantly more improvement in the ALA group than the Photosan group for the following outcomes: dysphagia (p = 0.02), tumour stenosis (p = 0.00000) and tumour length (p = 0.000014) QoL and return to normal activity Karnovsky Performance status improved by 23% for ALA vs 44% for Photosan, not significant (p = 0.12) AEs No barotrauma of the ear was observed. No sunburn occurred in either group. There were no major AEs. 30-day mortality was 0%. Minor complications were: postinterventional odynophagia (nine in ALA group vs 13); fever up to 39° in the afternoon of the interventional day (five vs eight); chest pain for 1 or 2 d (nine vs 13). After ALA administration all patients experienced nausea Resource use Hospitalisation was 4–6 d in both treatment groups Trial treatments ALA- PDT vs PDT with Photosan (HpD). Both performed with additional hyperbaric oxygenation Intervention ALA–PDT: Diagnostic work-up was performed using barium oesophagogram, oesophagogastroscopy, bronchoscopy and CT scans. Oral administration of ALA (60 mg/kg) then skin protection by camouflage for 24 hr. 6–8 hr after ALA, PDT was carried out using a fibre with 2-cm tip radial light-diffusing cylinder, inserted through the biopsy channel of the endoscope. Light dose was 300 J/cm fibre and 630-nm light was applied by KTP-Nd: YAG laser having a DYE module. Additional hyperbaric oxygenation was applied (after an ear, nose and throat check-up) at level 2 ATA using a Scuba valve system. Treatment was performed under short-term intravenous anaesthesia. Endoscopy was performed 2–3 d after PDT and necrotic tissue removed. Endoscopy was then performed after 1 mth, then every 3 mth. Increased tumour length and dysphagia at FU indicated further PDT treatment. No treatment was repeated within 3 mth after the 1st PDT session Comparator Photosan-PDT: As for ALA– PDT except intravenous administration of Photosan (2 mg/kg), 48 hr before PDT Treatment intention Palliative Type(s) of cancer and histology Advanced oesophageal cancer Main eligibility criteria Patients that were not eligible for resection treatment due to poor performance status, functional and/or anatomical inoperability, and/or refusing surgery were included Patient characteristics % Male: 78 Age range: 46–88 yr Mean age: ALA, 69 yr; Photosan 68 yr Cancer stage: III, 17; IV 32. Dysphagia score varied with most in level 2 or 3 but no significant differences Overall there were 13 SCC, 14 adenocarcinoma Further patient characteristics were reported Concomitant treatment Not stated Authors Maier et al. (2001) 118 Linked publications120 Data source Full published paper Country Austria Language English Study design Non-RCT No. of participants Total: 49 Intervention: 22 (ALA–PDT) Comparator: 27 (Photosan-PDT) No. of recruiting centres Not stated Follow-up period and frequency FU at 1 mth, then every 3 mth ATA, atmosphere absolute.
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT eradicates early SCCs (T1a and T1b) of the oesophagus efficiently. Transmural necroses leading to fistulas can be avoided using a low-penetrating wavelength of laser light (green light at 514.5 nm instead of red light at 630 or 652 nm). Stenoses always result from circumferential irradiation of the oesophageal wall, and this can be avoided by using a 180° or 240° windowed cylindrical light distributor Brief study appraisal This was a relatively small trial with multiple comparator arms, the methods were not clearly reported and as the authors themselves comment – the small samples preclude any firm conclusions, so the results may not be reliable Mortality Not assessed Morbidity No truly selective necrosis was seen with HpD, Photofrin II or mTHPC when irradiation was at 20 hr. With mTHPC (irradiation at 96 h) some patients had necroses that were selective. CR rates: HpD = 89%, mTHPC = 86%, Photofrin II = 75%. Failures of treatment according to sensitiser used were 1/9 (11%) in the HpD group; 2/8 (25%) Photofrin II group; 2/14 (14%) mTHPC group. Failures of treatment according to wavelength used were 2/15 (13%) for 630 or 652 nm; 3/16 (19%) for 514 nm QoL and return to normal activity Not assessed AEs All patients reported burning sensation during the injection of mTHPC. Major complications were: Stenoses (two), oesophagotracheal fistulas in PDT patients (630 or 652 nm) (two, one of which complicated by oesophageal stenosis). Three patients that did not follow prescribed precautions (not in methods) developed 2nd-degree sunburn on the face and hands (one HpD patient at 2 mth; 2 0.15 mg/kg mTHPC patients at 6 d) Resource use Not assessed Trial treatments HpD PDT vs Photofrin II PDT vs mTHPC 0.15 mg/kg (652 nm) PDT vs mTHPC 0.3 mg/kg (514 nm) PDT vs mTHPC 0.15 mg/kg (514 nm) PDT Intervention HpD PDT: Intravenous HpD was injected (3 mg/kg), then PDT given with an argon ion pumped-dye laser after 72 hr (630 nm, 100 J/cm2 , 80 mW/cm2 ) for 21 min. Surface irradiation using 180 or 240° windowed cylindrical light distributors (15 mm diameter) was used Comparator Photofrin II PDT: intravenous Photofrin II was injected (1 or 2 mg/kg), then PDT given with an argon ion pumped-dye laser after 72 hr [630 nm (most patients) or 514nm, mean light dose 100 J/cm2 , 90 mW/cm2 ] for 19 min. Surface irradiation using 180° or 240° windowed cylindrical light distributors (15-mm diameter) was used 2nd comparator mTHPC 0.15 mg/kg (652 nm) PDT: Intravenous mTHPC was injected (0.15 mg/kg), then PDT given with an argon ion pumped-dye laser after 20 hr (652 nm, 6 or 8 J/cm2 , 40 mW/cm2 ) for 3 min. Surface irradiation using 180 or 240° windowed cylindrical light distributors (15-mm diameter) were used 3rd comparator mTHPC 0.3 mg/kg (514 nm) PDT: intravenous mTHPC was injected (0.3 mg/kg), then PDT given with a argon ion pumped-dye laser after 20 hr (514 nm, 30 J/cm2 , 50 mW/cm2 ) for 10 min. Surface irradiation using 180 or 240 windowed cylindrical light distributors (15-mm diameter) was used 4th comparator mTHPC 0.15 mg/kg (514 nm) PDT: intravenous mTHPC was injected (0.15 mg/kg), then PDT given with an argon ion pumped-dye laser after 20 or 96 hr (514 nm, 75 J/cm2 , 90 mW/cm2 ) for 14 min. Surface irradiation using 180 or 240° windowed cylindrical light distributors (15-mm diameter) was used Treatment intention Curative Type(s) of cancer and histology Early SCC of the oesophagus Main eligibility criteria Biopsy confirmed early SCC. Patients with porphyria were excluded Patient characteristics % Male: 92 Age range: 42–79 yr Mean age: 56 yr Twenty-two patients had a history of primary invasive head and neck cancer, two had no such history. Two patients had synchronous tumours, five patients developed metachronous early cancers Concomitant treatment None Authors Savary et al. (1998) 109 Data source Full published paper Country Switzerland Language English Study design Non- RCT No. of participants Total: 24 (31 tumours) Intervention: Nine tumours (HpD-PDT) Comparator: Eight tumours (Photofrin II- PDT) 2nd Comparator: Two tumours (mTHPC-PDT, 0.15 mg/kg with 652 nm) 3rd Comparator: One tumour (mTHPC-PDT, 0.3 mg/kg with 514 nm) 4th Comparator: 11 tumours (mTHPC-PDT, 0.15 mg/kg with 514 nm) No. of recruiting centres Not stated Follow-up period and frequency FU at 10 d, 3 mth, then 6-mth intervals © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 261
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APPENDICES - NIHR Health Technology Assessment Programme

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