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

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xvi Executive summary of study designs were considered. Only full economic evaluations that compared two or more options and considered both costs and consequences (including cost-effectiveness, cost–utility and cost–benefit analysis) were included. Data extraction and quality assessment Data from included studies were extracted by one reviewer and independently checked for accuracy by a second reviewer. Individual studies were assessed for quality by one reviewer and independently checked for accuracy by a second reviewer. Methods of analysis/synthesis The results of the data extraction and quality assessment for each study of clinical effectiveness are presented in structured tables and as a narrative summary. Where appropriate, outcomes were synthesised using formal analytic approaches. For the cost-effectiveness section of the report, details of each identified published economic evaluation, together with a critical appraisal of its quality, are presented in structured tables. A new cost-effectiveness model was developed in order to establish the cost-effectiveness of docetaxel compared with a range of potential comparators. The model was developed to estimate costs from the perspective of the UK NHS and health outcomes in terms of life-years gained and quality-adjusted life-years (QALYs) for the full range of relevant treatment strategies. A simple two-state Markov model was constructed to calculate mean survival and to account for discounting. The model was run for a time horizon of 15-years in order to obtain a robust estimate of mean survival. A separate review was undertaken to identify sources of utility data required to estimate QALYs. Sensitivity analyses were also undertaken to explore the robustness of the main analysis to alternative assumptions related to quality of life. Monte Carlo simulation was used to propagate uncertainty in input parameters through the model in such a way that the results of the analysis could be presented with their uncertainty. The impact of uncertainty surrounding the decision was established using value of information and implementation approaches. Handling the company submissions No substantive additional clinical effectiveness data were presented in the company submission. The economic evaluation included in the company submission was assessed and used to inform the development of the new model. Results A total of 1065 titles and abstracts were screened for inclusion in the review of clinical effectiveness and cost-effectiveness and 267 records were ordered as full papers. Seven RCTs were identified that met our inclusion criteria. Three of these trials used docetaxel compared with mitoxantrone plus prednisone, three trials used mitoxantrone plus a corticosteroid compared with a corticosteroid and one trial used mitoxantrone plus prednisone compared with mitoxantrone plus prednisone plus clodronate. Clinical effectiveness We found one large, good-quality trial (n = 1006) that assessed the intervention under consideration: docetaxel plus prednisone; this was in comparison with mitoxantrone plus prednisone (TAX 327). No other trials were found that assessed the clinical effectiveness of docetaxel plus prednisone. The results of this trial showed statistically significant improvements with 3-weekly docetaxel plus prednisone compared with mitoxantrone plus prednisone, in terms of overall survival [hazard ratio (HR) for death = 0.76 [95% confidence interval (CI): 0.62 to 0.94)], quality of life [relative risk (RR) = 1.67 (95% CI: 1.14 to 2.45)], pain response [RR = 1.58 (95% CI: 1.1 to 2.27)] and prostate specific antigen (PSA) decline [RR = 1.41 (95% CI: 1.14 to 1.73)]. Tumour response rate was higher for the 3-weekly docetaxel plus prednisone group than the mitoxantrone plus prednisone group, but this difference was not statistically significant. The improved outcomes for docetaxel plus prednisone were associated with more grade 3–4 adverse events; however, this had no detrimental effect on quality of life, which was significantly improved in the 3-weekly docetaxel group. Progression-free survival was not assessed in this trial. Since docetaxel plus prednisone is only compared with mitoxantrone plus prednisone, it was considered important to consider other evidence which would inform a comparison against other potentially relevant comparators (e.g. other chemotherapy-based treatments and best supportive care). Therefore, we searched for all other treatments that were compared with mitoxantrone plus a corticosteroid. We found three trials comparing mitoxantrone plus prednisone with another chemotherapy regimen: one trial that compared mitoxantrone plus prednisone with docetaxel plus prednisone plus estramustine, one trial that compared
mitoxantrone plus prednisone with docetaxel plus estramustine, and one trial that compared mitoxantrone plus prednisone with mitoxantrone plus prednisone plus clodronate. Both treatments that included docetaxel were superior to mitoxantrone plus prednisone in terms of overall survival (although the difference was not statistically significant for docetaxel plus prednisone plus estramustine), response rate (although the difference was not statistically significant for docetaxel plus estramustine) and progression-free survival (although this was only assessed for docetaxel plus estramustine in comparison with mitoxantrone plus prednisone). Docetaxel plus estramustine was associated with more adverse events compared with mitoxantrone plus prednisone. No significant differences were found between mitoxantrone plus prednisone plus clodronate and mitoxantrone plus prednisone without clodronate. In addition, we found three trials that compared mitoxantrone plus a corticosteroid with best supportive care, using corticosteroids. Two of these used prednisone (5 mg twice daily) as the comparator and one compared mitoxantrone plus hydrocortisone with hydrocortisone (40 mg given in two divided doses daily). One of the trials included men with asymptomatic mHRPC, another included men with symptomatic mHRPC, with symptoms including pain and disease progression and the third included all men with progressive mHRPC. One trial allowed patients to cross over during the trial, which resulted in 50 out of 81 patients randomised to prednisone receiving additional mitoxantrone; the other two trials did not allow crossovers. The combined result of these three trials showed very little difference between mitoxantrone plus corticosteroids compared with corticosteroids alone in terms of overall survival [HR = 0.99 (95% CI: 0.82 to 1.20)]. Other outcomes could not be pooled because they were measured differently in the three trials. However, in the two studies that measured health-related quality of life and pain responses, the mitoxantrone groups had statistically significant improvements compared with the corticosteroid groups. High losses to follow-up for these outcomes dictate that these results should be interpreted cautiously. An adjusted indirect comparison was performed to estimate the relative efficacy of docetaxel plus prednisone versus corticosteroids. The results of the indirect comparison showed that docetaxel plus prednisone seems to be superior to © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Health Technology Assessment 2007; Vol. 11: No. 2 prednisone alone in terms of overall survival. However, this is based on an indirect comparison using one good-quality trial comparing docetaxel plus prednisone with mitoxantrone plus prednisone (TAX 327) and three trials comparing mitoxantrone plus corticosteroids with corticosteroids, that differed in terms of patient population and methodology. In summary, a direct comparison of docetaxel plus prednisone versus mitoxantrone plus prednisone in an open-label randomised trial showed improved outcomes for docetaxel plus prednisone. Two other chemotherapy regimens that included docetaxel: docetaxel plus estramustine and docetaxel plus prednisone plus estramustine, also showed improved outcomes in comparison with mitoxantrone plus prednisone. Three trials that compared mitoxantrone plus a corticosteroid with a corticosteroid alone were identified and their results for overall survival were combined, which showed very little difference between the two groups. Mitoxantrone plus prednisone plus clodronate showed no significant differences in comparison with mitoxantrone plus prednisone. Our review of the data suggests that docetaxel plus prednisone is the most effective treatment for men with mHRPC. Cost-effectiveness The systematic literature search identified only one study which met the criteria for inclusion in the cost-effectiveness review. A separate costeffectiveness analysis was also submitted by the manufacturer (Sanofi-Aventis). Of the cost-effectiveness evidence reviewed, only the manufacturer’s submission was considered directly relevant from the perspective of the NHS. The review of this evidence highlighted potential limitations within the submission in its use of data, the range of comparators considered and the lack of quality adjustment in the final outcome. These limitations led to the development of a new model with the aim of providing a more comprehensive range of comparators (including a comparison with other chemotherapy regimens and prednisone/prednisolone alone) for the analysis of the cost-effectiveness of docetaxel plus prednisone/prednisolone from the perspective of the NHS. Two separate analyses were undertaken based on different sets of potentially relevant comparators. Despite the use of separate analyses, the estimates of cost-effectiveness provided in both analyses were similar. This model indicated that mitoxantrone plus a corticosteroid dominates a corticosteroid alone (i.e. it is cheaper and more effective). Compared with mitoxantrone plus xvii
Page 1 and 2: A systematic review and economic mo
Page 3 and 4: A systematic review and economic mo
Page 5 and 6: Objectives: A systematic review was
Page 7 and 8: Glossary and list of abbreviations
Page 9 and 10: 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 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
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Page 37 and 38: tumour response was reported for on
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Page 41 and 42: decrease in PSA level (51 and 39% c
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Page 53 and 54: Effectiveness of mitoxantrone plus
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Page 57 and 58: Progression-free survival It is not
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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
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TABLE 24 Other in-trial costs a bod
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TABLE 27 Cost-effectiveness results
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Introduction The review of cost-eff
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TABLE 28 Regression coefficients fr
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cancer QoL estimation. Studies whic
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Localised Metastatic mHRPC Bennet (
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TABLE 34 Unit costs of drugs from t
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were assigned to the total follow-u
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Probability cost-effective given da
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Probability cost-effective given da
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TABLE 43 Utility values including/e
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was set to be 1.5 years based on th
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Population value of implementation/
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76 Discussion (CCI-NOV22) and least
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78 Discussion subsequent chemothera
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Rodolphe Perard received funding fr
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84 References Compendium; 2004. URL
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86 References (D) in patients (pts)
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88 References 100. Aventis Pharma.
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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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