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84 References Compendium; 2004. URL: http://emc.medicines. org.uk/emc/industry/default.asp?page=displaydoc. asp&documentid=1511. Accessed 24 August 2005. 23. Centre for Reviews and Dissemination. Undertaking systematic reviews of research on effectiveness: CRD’s guidance for those carrying out or commissioning reviews [CRD Report 4]. 2nd ed. York: Centre for Reviews and Dissemination; 2001. 24. Drummond M, O’Brien B, Stoddart G, Torrance G. Methods for the economic evaluation of health care programmes. Oxford: Oxford Medical Publications; 1997. 25. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 1998;17:2815–34. 26. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629–34. 27. Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer [TAX 327]. N Engl J Med 2004;351:1502–12. 28. Oudard S, Banu E, Beuzeboc P, Voog E, Dourthe LM, Hardy-Bessard AC, et al. Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer. J Clin Oncol 2005;23:3343–51. 29. Petrylak DP, Tangen CM, Hussain MHA, Lara PN, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer [SWOG 9916]. N Engl J Med 2004;351:1513–20. 30. Berry W, Dakhil S, Modiano M, Gregurich M, Asmar L. Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer. J Urol 2002;168:2439–43. 31. Tannock IF, Osoba D, Stockler MR, Ernst DS, Neville AJ, Moore MJ, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14:1756–64. 32. Kantoff PW, Halabi S, Conaway M, Picus J, Kirshner J, Hars V, et al. Hydrocortisone with or without mitoxantrone in men with hormonerefractory prostate cancer: results of the Cancer and Leukemia Group B 9182 study. J Clin Oncol 1999;17:2506-13. 33. Ernst DS, Tannock IF, Winquist EW, Venner PM, Reyno L, Moore MJ, et al. Randomized, doubleblind, controlled trial of mitoxantrone/prednisone and clodronate versus mitoxantrone/prednisone and placebo in patients with hormone-refractory prostate cancer and pain. J Clin Oncol 2003;21:3335–42. 34. Dagher R, Li N, Abraham S, Rahman A, Sridhara R, Pazdur R. Approval summary: docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer. Clin Cancer Res 2004;10:8147–51. 35. Eisenberger MA, de Wit R, Berry W, Bodrogi I, Pluzanska A, Chi K, et al. A multicenter phase III comparison of docetaxel (D) plus prednisone (P) and mitoxantrone (MTZ) plus P in patients with hormone-refractory prostate cancer (HRPC) [abstract]. J Clin Oncol 2004;22(14S):4. 36. Eisenberger MA, de Wit R, Berry W, Bodrogi I, Pluzanska A, Chi K, et al. A multicenter phase III comparison of docetaxel (D) + prednisone (P) and mitoxantrone (MTZ) + P in patients with hormone-refractory prostate cancer (HRPC) [conference abstract]. Proc Am Soc Clin Oncol 2004;22(14S):4. URL: http://www.asco.org/portal/ site/ASCO/menuitem.34d60f5624ba07fd506fe310e e37a01d/?vgnextoid=76f8201eb61a7010VgnVCM 100000ed730ad1RCRD&vmview=abst_detail_view &confID=26&abstractID=2330. Accessed 4 May 2005. 37. Center for Drug Evaluation and Research. Approval package for: application number: 20-449/S-028 [Taxotere in combination with prednisone]: medical review(s) [pdf on the Internet]. Center for Drug Evaluation and Research; 2004. URL: http://www.fda.gov/cder/foi/nda/2004/20- 449s028_Taxotere_Medr.PDF. Accessed 26 May 2005. 38. Oudard S, Banu E, Vannetzel JM, Beuzeboc P, Dourthe LM, Voog E, et al. Results of a phase II randomized trial of docetaxel (D), estramustine (E) and prednisone (P) – two schedules – versus mitoxantrone (M) and prednisone in patients (pts) with hormone refractory prostate cancer (HRPC) [abstract]. Ann Oncol 2002;13 Suppl 5:90. 39. Oudard S, Beuzeboc P, Dourthe LM, Voog E, Hardy Besard AC, Coscas I, et al. Preliminary results of a phase II randomized trial of docetaxel (D), estramustine (E) and prednisone (P) – two schedules – versus mitoxantrone (M) and prednisone in patients (pts) with hormone refractory prostate cancer (HRPC) [conference abstract: no. 706]. In 2002 ASCO Annual Meeting. Alexandria, VA: American Society of Clinical Oncology. Available from: URL: http://www.asco.org/portal/site/ASCO/menuitem. 34d60f5624ba07fd506fe310ee37a01d/?vgnextoid= 76f8201eb61a7010VgnVCM100000ed730ad1RCR D&vmview=abst_detail_view&confID=16&abstract ID=706. Accessed 4 May 2005.
40. Oudard S, Banu EB, Voog E, Hardy-Bessard H, Linassier C, Beuzeuboc P, et al. Phase II randomised trial of docetaxel (D), estramustine (E) and prednisone (P) – two schedules – versus mitoxantrone (M) and prednisone in patients (PTS) with hormone refractory prostate cancer (HRPC) [conference abstract]. Eur Urol Suppl 2003;2:189. 41. Petrylak DP, Tangen C, Hussain M, Lara PN, Jones J, Talpin ME, et al. SWOG 99-16: randomized phase III trial of docetaxel (D)/estramustine (E) versus mitoxantrone(M)/prednisone(p) in men with androgen-independent prostate cancer (AIPCA). J Clin Oncol 2004;22:3. 42. Southwest Oncology Group, National Cancer Institute, Cancer and Leukemia Group B, North Central Cancer Treatment Group. Combination therapy in treating patients with advanced prostate cancer that have not responded to hormone therapy [web page on the Internet]. Bethesda, MD: National Institutes of Health. URL: http://www.clinicaltrials.gov/ ct/show/NCT00004001. Accessed 22 December 2004. 43. Berry DL, Moinpour CM, Jiang C, Vinson LV, Lara PN, Lanier S, et al. Quality of life (QOL) and pain in advanced stage prostate cancer: impact of missing data on evaluating palliation in SWOG 9916. J Clin Oncol 2004;22 (14 Suppl):401s. 44. Gregurich M, Gregurich M, Asmar L. Phase III study of mitoxantrone/low-dose prednisone versus low-dose prednisone alone in patients with asymptomatic hormone-refractory carcinoma of the prostate [conference abstract: no. 1321]. In 2000 ASCO Annual Meeting. Alexandria, VA: American Society of Clinical Oncology. URL: http://www.asco.org/portal/site/ASCO/menuitem. 34d60f5624ba07fd506fe310ee37a01d/?vgnextoid= 76f8201eb61a7010VgnVCM100000ed730ad1RCR D&vmview=abst_detail_view&confID=2&abstractI D=200942. Accessed 11 May 2005. 45. Dowling AJ, Panzarella T, Ernst DS, Neville AJ, Moore MJ, Tannock IF. A retrospective analysis of the relationship between changes in serum PSA, palliative response and survival following systemic treatment in a Canadian randomized trial for symptomatic hormone-refractory prostate cancer. Ann Oncol 2001;12:773–8. 46. Osoba D, Tannock IF, Ernst DS, Neville AJ. Health-related quality of life in men with metastatic prostate cancer treated with prednisone alone or mitoxantrone and prednisone. J Clin Oncol 1999;17:1654–63. 47. Tannock I, Osoba D, Ernst S, Neville A, Moore M, Armitage G, et al. Chemotherapy with mitoxantrone (M) and prednisone (P) palliates patients with hormone-resistant prostate cancer (HRPC): results of a randomized Canadian trial [conference abstract: no. 653]. Proceedings of ASCO 1995;14:245. © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Health Technology Assessment 2007; Vol. 11: No. 2 48. Stockler MR, Osoba D, Goodwin P, Corey P, Tannock IF. Responsiveness to change in healthrelated quality of life in a randomized clinical trial: a comparison of the prostate cancer specific quality of life instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. J Clin Epidemiol 1998;51:137–45. 49. Moore MJ, Tannock I, Osoba D, Stockler M, Ernst DS, Neville A, et al. Chemotherapy with mitoxantrone and low dose prednisone provides useful palliation for some patients with hormonally resistant prostate cancer (HRPC) [conference abstract]. Proc Am Urol Assoc 1996;155 Suppl:610A. 50. Dowling AJ, Panzarella T, Tannock IF. Relationship between changes in serum prostatic specific antigen (PSA) and palliative response following treatment of symptomatic hormone-refractory prostate cancer (HRPC) [conference abstract: no. 1248]. In 1998 ASCO Annual Meeting. Alexandria, VA: American Society of Clinical Oncology. URL: http://www.asco.org/portal/ site/ASCO/ menuitem.34d60f5624ba07fd506fe310ee37a01d/? vgnextoid=76f8201eb61a7010VgnVCM100000ed7 30ad1RCRD&vmview=abst_detail_view&confID= 31&abstractID=13467. Accessed 7 February 2005. 51. Kantoff PW, Conaway M, Winer E, Picus J, Vogelzang NJ. Hydrocortisone (HC) with or without mitoxantrone (M) in patients (pts) with hormone refractory prostate cancer (HRPC): preliminary results from a prospective randomized Cancer and Leukemia Group B study (9182) comparing chemotherapy to best supportive care [abstract]. J Clin Oncol 1996;14:1748. 52. National Cancer Institute. Phase III randomized study of mitoxantrone and prednisone with or without clodronate in patients with hormone refractory metastatic prostate cancer and pain [web page on the Internet]. Bethesda, MD: National Cancer Institute; 2001. [cited 2005 May 5]. URL: http://www.cancer.gov/ search/ViewClinicalTrials.aspx?cdrid= 66102&version=HealthProfessional&protocol searchid=1595737. Accessed 5 May 2005. 53. Ernst DS, Tannock IF, Venner PM, Winquist EW, Reyno L, Walker H, et al. Randomized placebo controlled trial of mitoxantrone/prednisone and clodronate versus mitoxantrone/prednisone alone in patients with hormone refractory prostate cancer (HRPC) and pain: National Cancer Institute of Canada Clinical Trials Group study [abstract]. In 2002 ASCO Annual Meeting. Alexandria, VA: American Society of Clinical Oncology. URL: http://www.asco.org/ac/1,1003,_ 12-002640-00_18-0016-00_19-00705,00.asp. Accessed 11 May 2005. 54. Eymard J-C, Joly F, Priou F, Zannetti A, Ravaud A, Kerbrat P, et al. Phase II randomized trial of docetaxel plus estramustine (DE) versus docetaxel 85
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A systematic review and economic mo
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A systematic review and economic mo
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Objectives: A systematic review was
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Glossary and list of abbreviations
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Glossary Absolute risk reduction Th
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Glossary continued Expected value o
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Glossary continued Progression-free
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List of abbreviations ASCO American
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xvi Executive summary of study desi
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xviii Executive summary prednisone/
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Description of underlying health pr
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● Patients with severe fluid rete
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Search strategy As stated in Chapte
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consensus and, if necessary, a thir
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Quantity of research available A to
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TABLE 1 Summary of included RCTs St
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TABLE 2 Treatment comparisons relat
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tumour response was reported for on
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TABLE 4 Summary results table for d
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decrease in PSA level (51 and 39% c
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Survival (%) 100 80 60 40 20 0 0 co
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TABLE 8 Summary results table for d
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TABLE 9 Grade 3 or 4 adverse events
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Also used was the core questionnair
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these, 69 patients had measurable t
Page 53 and 54: Effectiveness of mitoxantrone plus
Page 55 and 56: over to receive additional mitoxant
Page 57 and 58: Progression-free survival It is not
Page 59 and 60: compared with corticosteroids. The
Page 61 and 62: statistically significant improveme
Page 63 and 64: Summary of studies included in the
Page 65 and 66: TABLE 19 Percentage of costs by res
Page 67 and 68: TABLE 21 Summary of submission by S
Page 69 and 70: TABLE 24 Other in-trial costs a bod
Page 71 and 72: TABLE 27 Cost-effectiveness results
Page 73 and 74: Introduction The review of cost-eff
Page 75 and 76: TABLE 28 Regression coefficients fr
Page 77 and 78: cancer QoL estimation. Studies whic
Page 79 and 80: Localised Metastatic mHRPC Bennet (
Page 81 and 82: TABLE 34 Unit costs of drugs from t
Page 83 and 84: were assigned to the total follow-u
Page 85 and 86: Probability cost-effective given da
Page 87 and 88: Probability cost-effective given da
Page 89 and 90: TABLE 43 Utility values including/e
Page 91 and 92: was set to be 1.5 years based on th
Page 93: Population value of implementation/
Page 96 and 97: 76 Discussion (CCI-NOV22) and least
Page 98 and 99: 78 Discussion subsequent chemothera
Page 101: Rodolphe Perard received funding fr
Page 106 and 107: 86 References (D) in patients (pts)
Page 108 and 109: 88 References 100. Aventis Pharma.
Page 110 and 111: 90 References low-dose prednisone i
Page 112 and 113: 92 References 180. Kozloff M, Robin
Page 114 and 115: 94 References locally advanced pros
Page 116 and 117: 96 References 251. Scholz MC, Guess
Page 119 and 120: Clinical effectiveness Searching fo
Page 121 and 122: 1. Prostatic Intraepithelial Neopla
Page 123 and 124: 19. donataxel 20. doxetal 21. doxmi
Page 125 and 126: 6. Mitozantrone.ti,ab. 7. Mitoxantr
Page 127 and 128: Texot or Trazoteva or Trixotene or
Page 129 and 130: 1. (docetaxel OR asodecel OR doxeta
Page 131 and 132: 10. (index of wellbeing or quality
Page 133 and 134: Appendix 2 Excluded studies Study d
Page 135 and 136: Study details Reason for exclusion
Page 137 and 138: Meeting: 2004 ASCO Annual Meeting C
Page 139 and 140: Studies of clinical effectiveness w
Page 141 and 142: Using the method outlined by Parmar
Page 143 and 144: Appendix 6 Data extraction tables
Page 145 and 146: Study details and Participant detai
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Study details and Participant detai
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158 Appendix 7 Ernst et al. 33 Qual
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Appendix 9 © Queen’s Printer and
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Sanofi-Aventis 61 Bloomfield et al.
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Sanofi-Aventis 61 Bloomfield et al.
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168 Appendix 10 TABLE 51 Mean (SD)
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170 Appendix 10 TABLE 54 Distributi
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172 Appendix 10 TABLE 57 Mean stand
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174 Appendix 11 TABLE 63 Drug and a
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176 Appendix 12 Scenario: moderate
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178 Appendix 13 ● You occasionall
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Members Chair, Professor Tom Walley
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Members Chair, Professor Bruce Camp
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Feedback The HTA Programme and the
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