APPENDICES - NIHR Health Technology Assessment Programme

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262 Appendix 17 Study details Population details Treatment details Results Interpretation Authors’ conclusions In poor surgical candidates with superficial oesophageal carcinoma PDT and EMR achieved outcomes comparable to oesophagectomy in good surgical candidates. PDT and EMR are reasonable alternatives to oesophagectomy for selected patients Brief study appraisal This small study was available only as an abstract and few methodological details were reported. The study populations for the different interventions did not appear to be comparable at baseline with PDT/ EMR patients chosen if suboptimal for surgery. In addition no statistical tests were carried out to verify the findings, the results of this study may therefore not be reliable The authors’ conclusions do not follow from the results reported Mortality Not assessed Morbidity Eradication of lesions was achieved in 9/12 (75%) PDT, 5/6 (83%) EMR and 18/19 (95%) oesophagectomy patients QoL and return to normal activity Not assessed AEs Stricture occurred in 6/12 (50%) PDT, 0/6 EMR and 10/19 (53%) oesophagectomy patients. ≥ 3 dilatations occurred in 4/12 (33%) PDT, 0/6 EMR and 7/19 (37%) oesophagectomy patients. Other complications were reported for small numbers of patients Resource use Not assessed Trial treatments PDT vs EMR vs Oesophagectomy Intervention PDT: No details reported Comparator EMR: No details reported 2nd comparator Oesophagectomy: No details reported Treatment intention Curative Type(s) of cancer and histology Superficial oesophageal cancer Main eligibility criteria Superficial oesophageal cancer determined by EUS and CT including HGD, carcinoma in situ or intramucosal carcinoma Patient characteristics Mean age: PDT, 76; EMR, 73; oesophagectomy, 65 Thirty-six adenocarcinomas, one SCC Concomitant treatment Not stated Authors Scotiniotis et al. (2000) 110 Data source Abstract Country USA Language English Study design Non-RCT No. of participants Total: 37 Intervention: 12 (PDT) Comparator: Six EMR 2nd Comparator: 19 (oesophagectomy) No. of recruiting centres Not stated Follow-up period and frequency Mean FU 15 mth (range 2–28 mth). PDT and EMR patient FU 4–6 wk after treatment, then every 3–6 mth; oesophagectomy patient FU dictated by symptoms EMR, endoscopic mucosal resection.
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions Radiotherapy combined with PDT could obviously enhance the long-term survival rate of patients with advanced oesophageal cancer Brief study appraisal This was a brief report and some methodological aspects were not clearly reported. The p-values were not reported consistently between the abstract and the text making it difficult to clarify the significant differences between groups Mortality The 5-yr survival rate was 29.9% in the PDT group compared with 16.7% (p = 0.05). The 10-yr survival rate was 16.7% in the PDT group vs 10.0% (p < 0.05) Morbidity Not assessed QoL and return to normal activity Not assessed AEs All PDT patients experienced pigmentation, and swelling and itchiness. All PDT patients also experienced pain when swallowing for 3–5 d (some patients had pain for > 10 d and discontinued treatment). 23 died in the PDT group: loss to FU two; uncontrolled localisation 13 including one due to blockage of oesophagus; metastases eight; other disease one; unknown cause one. 26 died in the radiotherapy group: loss to FU one; uncontrolled localisation 18, including two due to blockage of oesophagus; metastases four; other disease two; unknown cause two Resource use Not assessed Trial treatments PDT with radiotherapy vs radiotherapy alone Intervention PDT with radiotherapy: Radiotherapy for 4 wk (40 Gy). Then intravenous haematoporphyrin derivative (5 mg/kg bw) before illumination with 630-nm red light (400– 500 W/cm2 at each part of the tumour for 15 min) at 48 and 72 hr Comparator Radiotherapy: 40 Gy for 4 wk Treatment intention Palliative Type(s) of cancer and histology Advanced oesophageal cancer Main eligibility criteria Diagnosed with advanced oesophageal cancer, suitable for treatment Patient characteristics Age: under 70 yr Cancer length: 5–10 cm. No metastases Concomitant treatment Not stated Authors Zhang et al. (2003) 119 Data source Full published paper Country China Language Chinese Study design RCT No. of participants Total: 60 Intervention: 30 Comparator: 30 No. of recruiting centres One hospital (outpatients) Follow-up period and frequency FU at 5 and 10 yr © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 263
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170 Appendix 9 107. Okunaka T, Kato
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APPENDICES - NIHR Health Technology Assessment Programme

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