APPENDICES - NIHR Health Technology Assessment Programme

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244 Appendix 16 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT and APC are both effective for ablating BO. APC appears more effective but larger studies should assess impact on carcinoma development Brief study appraisal This was a relatively robust comparative trial (despite the sample size), which would also have benefited from the use of blinded outcome assessors. However, this study, like its related dosing study102 was of BO patients without dysplasia; such patients are often not treated at all, so the results appear to be of limited use in relation to clinical practice Mortality Not assessed Morbidity Significantly fewer treatments were performed in the APC group (median 3) than in the PDT group (median 5), p = 0.016. The median number of treatments required for successful ablation was two in the PDT group and three in the APC group, p = 0.189 Complete macroscopic reversal of the columnar segment to squamous epithelium was achieved in 50% of PDT patients and 97% of APC patients, p < 0.0001 AEs Major side effects for PDT were minimal with no strictures or perforations. Significant N&V occurred in 32% of patients who required further antiemetic treatment. Five patients reported cutaneous photosensitivity (mild erythema and pain). All APC patients reported discomfort and 91% reported transient dysphagia and odynophagia. All were resolved with oral analgesia over 3 d. No oesophageal perforations occurred, one patient developed dysphagia to solids and required four dilatations Resource use Not assessed Trial treatments ALA–PDT vs APC Intervention ALA–PDT: 30 mg/kg of ALA dissolved in 50 ml of orange juice taken orally, patient kept in a dim room prior to treatment (46 hr later). Endoscopy was carried out (with intravenous sedation, analgesia and an antiemetic) and a balloon applicator was placed over a guidewire (position confirmed endoscopically) and inflated to approximately 20 mmHg. Light was delivered using a cylindrical diffuser fibre – red laser light (635 nm 3W) at a fluence rate of 68 mW/cm2 and total light dose of 85 J/cm2 . Patients were discharged and advised to avoid bright lights for 24 hr. Follow-up at 4 wk – if residual Barrett’s epithelium patient was re-treated until re-epithelisation was complete or to a maximum of five treatments Comparator APC: endoscopy as per PDT protocol. APC generator set with gas flow of 2 l/min and power setting of 65 W. APC probe passed down biopsy channel and positioned with tip of probe 1 cm distal to the end of the scope. APC performed in a linear fashion coagulating strips of tissue approximately 2 mm wide at each pass. One-half of the affected circumference was treated at any one sitting on the rationale of reducing chances of stricture. Repeat treatment as per PDT but using APC Treatment intention Curative Type(s) of cancer and histology BO Main eligibility criteria Patients were invited to take part from an endoscopic screening programme (over 150 were approached). No further details reported Patient characteristics % Male: 81 Age range: 28–83yr Median age: 61 yr All patients had biopsy proven Barrett’s epithelium (median length of 4 cm, range 2–15cm). No patients had high or LGD Concomitant treatment 40 mg esomeprazole daily, with oral analgesia as required Authors Kelty et al. (2004) 98 Linked publications199–201 Data source Full published paper Country UK Language English Study design RCT No. of participants Total: 72 Intervention: 35 (PDT) Comparator: 37 (APC) No. of recruiting centres One Follow-up period and frequency 1 day, 4 wk then 6, 12 and 24 mth after successful treatment or five sessions
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT with ALA at 30 mg/kg with green or red laser is ineffective for eradication of HGD in BO. ALA at 60 mg/kg activated by 1000 J/cm red laser light has high efficacy for HGD in BO Brief study appraisal This trial, although small, was able to suggest a greater effectiveness with 60 mg red light. Such findings would need to be confirmed in larger trials and any AEs documented Mortality Not assessed Morbidity Phase 1 4 of 16 patients (25%) had HGD eradicated (three red light, one green light) The trial was paused following interim analysis. It then proceeded to Phase 2 Phase 2 Six of six patients in the 60-mg red light group had successful treatment, whereas one of five was successful in the 60-mg green light group (p = 0.01) 60-mg ALA red light was also more successful than 30-mg ALA red light (p = 0.03) and than 30 mg ALA green light (p = 0.005) AEs AEs were not all reported by group. All patients receiving 60 mg PDT showed minor, self-limiting abnormalities in the results of their liver function tests Resource use Not assessed Trial treatments ALA–PDT with red light vs ALA–PDT with green light Intervention Phase 1 (eight patients) ALA with red light: at 635 nm delivering a dose of 200 J/cm2. Laser treatment was applied 4 hr after oral ALA administration (30 mg/kg). Patients received up to three treatments with PDT 1 mth apart Phase 2 (six patients) As above but with 60 mg/kg ALA Comparator Phase 1 (eight patients) ALA with green light at 512 nm otherwise as for intervention Phase 2 (five patients) As above but with 60 mg/kg ALA Treatment intention Curative Type(s) of cancer and histology BO with HGD Main eligibility criteria Patients with BO with HGD. Patients were not allowed to receive chemotherapy or radiotherapy within 1 mth prior to PDT. Other exclusion criteria were provided Patient characteristics Not stated Concomitant treatment All patients received PPIs. Intravenous fluids and antiemetics were given pre-operatively Authors Mackenzie et al. (2008) 105 Linked publications202–204 Data source Full paper Country UK Language English Study design RCT No. of participants Total: 27 Intervention (ALA with red light): 14 Comparator: (ALA with green light): 13 No. of recruiting centres One Follow-up period and frequency 4 wk then every 3 mth for the 1st year then every 6 mth for the 2nd year, then yearly © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 245
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APPENDICES - NIHR Health Technology Assessment Programme

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