APPENDICES - NIHR Health Technology Assessment Programme

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176 Appendix 10 12. Wiedmann M, Caca K, Berr F, Schiefke I, Tannapfel A, Wittekind C, et al. Neoadjuvant photodynamic therapy as a new approach to treating hilar cholangiocarcinoma: a phase II pilot study. Cancer 2003;97:2783–90. 13. Wolkersdorfer G, Emmanuel K, Denzer U, Puespoek A, Neureiter D, Kiesslich T, et al. P-150 Temoporfin improves tumoricidal efficacy of photodynamic therapy (PDT) for bile duct cancer. International Liver Cancer Association Annual Conference, Chicago, 2008. p. 60. Case series (10 or more patients) 14. Abulafi AM, Allardice JT, Williams NS, van Someren N, Swain CP, Ainley C. Photodynamic therapy for malignant tumours of the ampulla of Vater. Gut 1995;36:853–6. 15. Itoi T, Sofuni A, Itokawa F, Shinohara Y, Takeda K, Nakamura K, et al. Salvage therapy in patients with unresectable hilar cholangiocarcinoma. Digestive Endoscopy 2006;18:232–8. 16. Maunoury V, Mordon S, Boyer J, Quentin V, Barthet M, Laugier R, et al. Results of a multicenter open study of photodynamic therapy (Photofrin) in 49 patients with cholangiocarcinoma. Photodynamic Therapy and Photodiagnosis in Clinical Practice, Brixen/Bressanone, 7–11 October 2008. 17. Ortner M. Photodynamic therapy for cholangiocarcinoma. J Hepatobiliary Pancreat Surg 2001;8:137–9. 18. Prasad GA, Wang KK, Baron TH, Buttar NS, Wongkeesong L-M, Roberts LR, et al. Factors associated with increased survival after photodynamic therapy for cholangiocarcinoma. Clin Gastroenterol Hepatol 2007;5:743–8. 19. Shim CS, Cheon YK, Cha SW, Bhandari S, Kim YS, Cho YD, et al. Percutaneous transhepatic photodynamic therapy for advanced bile duct cancer and role of intraductal ultrasonography (IDUS) in the follow-up and response assessment. Gastrointest Endosc 2003;57:A199. 20. Shim CS, Cheon YK, Cha SW, Bhandari S, Moon JH, Cho YD, et al. Prospective study of the effectiveness of percutaneous transhepatic photodynamic therapy for advanced bile duct cancer and the role of intraductal ultrasonography in response assessment. Endoscopy 2005;37:425–33. Case reports (single case or fewer than 10 patients) 21. Berr F, Tannapfel A, Lamesch P, Pahernik S, Wiedmann M, Halm U, et al. Neoadjuvant photodynamic therapy before curative resection of proximal bile duct carcinoma. J Hepatol 2000;32:352–7. 22. Burdick JS, Magee D, Miller G, Wright KB. Biliary photodynamic therapy alternative delivery technique. Endoscopy 2000;32:S63. 23. McCaughan JS, Jr, Mertens BF, Cho C, Barabash RD, Payton HW. Photodynamic therapy to treat tumors of the extrahepatic biliary ducts. A case report. Arch Surg 1991;126:111–13. 24. Nanashima A, Yamaguchi H, Shibasaki S, Ide N, Sawai T, Tsuji T, et al. Adjuvant photodynamic therapy for bile duct carcinoma after surgery: a preliminary study. J Gastroenterol 2004;39:1095–101. 25. Ortner MA, Liebetruth J, Schreiber S, Hanft M, Wruck U, Fusco V, et al. Photodynamic therapy of nonresectable cholangiocarcinoma. Gastroenterology 1998;114:536–42. 26. Rumalla A, Baron TH, Wang KK, Gores GJ, Stadheim LM, de Groen PC. Endoscopic application of photodynamic therapy for cholangiocarcinoma. Gastrointest Endosc 2001;53:500–4. 27. Suzuki S, Inaba K, Yokoi Y, Ohata K, Ota S, Azuma M, et al. Photodynamic therapy for malignant biliary obstruction: a case series. Endoscopy 2004;36:83–7. 28. Zoepf T, Jakobs R, Arnold JC, Apel D, Rosenbaum A, Riemann JF. Photodynamic therapy for palliation of nonresectable bile duct cancer – preliminary results with a new diode laser system. Am J Gastroenterol 2001;96:2093–7. 29. Zoepf T, Jakobs R, Rosenbaum A, Apel D, Arnold JC, Riemann JF. Photodynamic therapy with 5-aminolevulinic acid is not effective in bile duct cancer. Gastrointest Endosc 2001;54:763–6. 30. Zoepf T, Jakobs R, Arnold JC, Apel D. Photodynamic therapy (PDT) for palliation of non resectable bile duct cancer: first results with a new diode laser system. Gastroenterology 1999;116:G2357.
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Forty-three publications, with study designs that did not meet the inclusion criteria for the review, reported on patients with brain cancer being treated with PDT. Details are lacking for many of these publications, so the categorisations may not be reliable. There are two studies with some form of comparison group, but both studies are poorly reported and lack methodological details. 1–2 One comparative study reports the results of a Phase II trial of PDD/PDT in 26 patients with WHO grade IV recurrent glioblastoma who were sensitised with mTHPC (FOSCAN) prior to fluorescent guided resection and intraoperative PDT after 4 days. 2 This group of patients was compared with a control group of matched patients, but no details of how they were matched are provided. The other comparative study reported on 30 patients [27 glioma (nine of which were recurrences), two malignant meningioma, two metastatic brain cancer] treated with high-dose PDT (haematoporphyrin derivative and pumped dye laser) in addition to craniotomy with a radical or partial excision of the tumour. 1 The authors state that 30 comparable patients who were treated with surgery alone were selected at random as control subjects, but no details are provided so it is not clear how these patients were selected. Thirteen publications are described as being trials but without a comparator group, the number of patients ranging from 3 to 186. 3–15 Some of the publications appear to be related, either potential duplicate publications or reporting different outcomes for the same patients. Twenty-two publications report case series with at least 10 patients 16–37 and six publications report less than 10 patients, 38–43 two of which are single case reports. 38–43 Of the 22 publications, four had between 50 and 100 patients, 26,27,29,30 and only three had more than 100 patients (one of which included various treatments and so not all patients will have undergone PDT). 32,33,35 © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. Appendix 11 Brain cancer scoping Many of the publications appear to be from the same clinical groups (14 are authored by Muller et al. and six by Kostron et al.) and there may well be significant overlap in the results presented (updating as more patients have been treated). Muller et al. began two RCTs that were not completed (see Chapter 11, Stopped trials) and some of the publications authored by them appear to report characteristics of the cohort of trial patients, but not comparative results. References Observational comparative studies 1. Chen ZQ, Wu S, Zhu SG. Adjuvant photodynamic therapy in surgical management of cerebral tumors. SPIE 1993;1616:94–7. 2. Kostron H, Fiegele T, Akatuna E. Combination of FOSCAN mediated fluorescence guided resection and photodynamic treatment as new therapeutic concept for malignant brain tumors. Med Laser Appl 2006;21:285–90. Experimental non-comparative studies 3. Fedulov AS, Sakovich II, Sliakhtsin SV, Trukhachova TV. PDT of high-grade gliomas with Fotolon. Results of an open-label randomized clinical trial. Photodiagn Photodyn Ther 2008;5(Suppl. 1):S7. 4. Kostron H, Fritsch E, Grunert V. Photodynamic therapy of malignant brain tumours: a phase I/II trial. Br J Neurosurg 1988;2:241–8. 5. Laws ER, Jr, Cortese DA, Kinsey JH, Eagan RT, Anderson RE. Photoradiation therapy in the treatment of malignant brain tumors: a phase I (feasibility) study. Neurosurgery 1981;9:672–8. 6. Marks PV, Belchetz PE, Saxena A, Igbaseimokumo U, Thomson S, Nelson M, et al. Effect of photodynamic therapy on recurrent pituitary adenomas: clinical phase I/II trial: an early report. Br J Neurosurg 2000;14:317–25. 7. Muller P, Wilson B, Dougherty TJ. Photodynamic therapy of supratentorial gliomas. SPIE 1997;2972:14–26. 8. Muller P, Wilson B, Lilge L, Hitchcock M, Hertzel F, Chen Q, et al. Photodynamic therapy of malignant brain tumors: results from a Phase II trial and 177
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