Docetaxel with prednisone or prednisolone for the treatment of ...

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42 Results were identified and their results for overall survival were combined, which showed very little difference between the two groups. The only other chemotherapy regime found that did not include docetaxel, mitoxantrone plus prednisone plus clodronate, showed no significant differences in comparison with mitoxantrone plus prednisone. The review of the data suggests that docetaxel plus prednisone is the most effective treatment for men with mHRPC.
Summary of studies included in the cost-effectiveness review The systematic literature search detailed in the section ‘Search strategy’ (p. 7) identified only one published study which met the criteria for inclusion in the cost-effectiveness review. In addition, a separate cost-effectiveness analysis was also submitted by Sanofi-Aventis. The following sections provide a detailed overview of the cost-effectiveness evidence from each of these sources and an assessment of the quality and relevance of the data from the perspective of the NHS. Summary data extraction tables are reported for each review and the quality checklist for each study is reported in Appendix 9. An overall summary of the cost-effectiveness evidence is provided at the end of the chapter. Published economic evaluations Review of Bloomfield and colleagues (1998). 64 Economic evaluation of chemotherapy with mitoxantrone plus prednisone for symptomatic hormoneresistant prostate cancer: based on a Canadian randomized trial with palliative end-points Overview The paper reports an analysis of the costeffectiveness of mitoxantrone plus prednisone compared with prednisone alone. The evaluation was based on an analysis of patient-level data derived from prospective collection of resource use and patient outcome data from the CCI-NOV22 clinical trial. The analysis of this Canadian trial was undertaken from the perspective of a third-party payer (e.g. Provincial Ministry of Health). The primary outcome for the cost-effectiveness analysis was quality-adjusted life-years (QALYs) gained based on a comparison between the intervention groups. Mean total costs for each treatment were presented (comprising all inpatient and outpatient costs of hospital-based resource use including drug acquisition costs, laboratory and diagnostic imaging costs, radiotherapy costs, costs of blood Chapter 5 Economic review © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Health Technology Assessment 2007; Vol. 11: No. 2 products and costs of surgery). In addition, due to the extent of the crossover within the trial, cumulative costs over time were presented for the two treatment groups (as initially randomised) and for those in the prednisone group who did not cross over (ITT). Statistical techniques (Fieller’s theorem) were used to determine a confidence interval for the incremental cost-effectiveness ratio (ICER) and deterministic sensitivity analyses were undertaken to assess the impact of variation in the costs. A brief summary of the evaluation is provided in Table 18. The key features are described in more detail below. Summary of effectiveness data Estimates of QALYs were based on patient-level data from the CCI-NOV22 trial. Within the trial, patients completed the EORTC QLQ-C30 QoL questionnaire every 3 weeks. The values for the global QoL item were assumed to be equivalent to a rating scale and were converted to a 0–1 scale. In order to take account of the generally lower values assigned to QoL from valuation schemes which do not incorporate risk (e.g. rating scales), these values were transformed to provide estimates of utility using a published transformation equation: Utility = 1.07 × rating scale value when rating scale value 0.95 These utility values were then applied to the patient-level survival data to generate patient-level estimates of quality-adjusted survival. The patientlevel estimates were summated across each arm to generate mean total quality-adjusted survival for each treatment. No discounting was applied to the estimates of quality-adjusted survival due to the short nature of the follow-up. Summary of resource utilisation and cost data Resource use data for inpatient and outpatient hospital-based resources were collected alongside the CCI-NOV22 clinical trial, via chart review, for a sample of patients (n = 114/161) randomised to one of three Canadian centres. Other resource use 43
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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
Page 11 and 12: Glossary continued Expected value o
Page 13 and 14: Glossary continued Progression-free
Page 15: List of abbreviations ASCO American
Page 18 and 19: xvi Executive summary of study desi
Page 20 and 21: xviii Executive summary prednisone/
Page 23 and 24: Description of underlying health pr
Page 25 and 26: ● Patients with severe fluid rete
Page 27 and 28: Search strategy As stated in Chapte
Page 29 and 30: consensus and, if necessary, a thir
Page 31 and 32: Quantity of research available A to
Page 33 and 34: TABLE 1 Summary of included RCTs St
Page 35 and 36: TABLE 2 Treatment comparisons relat
Page 37 and 38: tumour response was reported for on
Page 39 and 40: TABLE 4 Summary results table for d
Page 41 and 42: decrease in PSA level (51 and 39% c
Page 43 and 44: Survival (%) 100 80 60 40 20 0 0 co
Page 45 and 46: TABLE 8 Summary results table for d
Page 47 and 48: TABLE 9 Grade 3 or 4 adverse events
Page 49 and 50: Also used was the core questionnair
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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: statistically significant improveme
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 104 and 105: 84 References Compendium; 2004. URL
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
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92 References 180. Kozloff M, Robin
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94 References locally advanced pros
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96 References 251. Scholz MC, Guess
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Clinical effectiveness Searching fo
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1. Prostatic Intraepithelial Neopla
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19. donataxel 20. doxetal 21. doxmi
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6. Mitozantrone.ti,ab. 7. Mitoxantr
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Texot or Trazoteva or Trixotene or
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1. (docetaxel OR asodecel OR doxeta
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10. (index of wellbeing or quality
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Appendix 2 Excluded studies Study d
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Study details Reason for exclusion
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Meeting: 2004 ASCO Annual Meeting C
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Studies of clinical effectiveness w
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Using the method outlined by Parmar
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Appendix 6 Data extraction tables
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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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