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

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158 Appendix 7 Ernst et al. 33 Quality criteria TAX 327 27 Oudard et al. 28 SWOG 9916 29 Berry et al. 30 CCI-NOV22 31 CALGB 9182 32 Was the method used to assign participants to the treatment groups really random? Yes Unclear Unclear Unclear Unclear Unclear Yes What method of assignment was used? Permuted Not reported Not reported Not reported Not reported Not reported Block blocks randomisation Was the allocation of treatment concealed? Yes Yes Unclear Unclear No Unclear Unclear What method was used to conceal treatment allocation? Centralised Centralised Not reported Not reported NA Not reported Not reported Was the number of participants who were randomised stated? Yes Yes Yes Yes Yes Yes Yes Were details of baseline comparability presented? Yes Yes Yes Yes Yes Yes Yes Was baseline comparability achieved? Yes Yes Yes Yes No No No Were the eligibility criteria for study entry specified? Yes Yes Yes Yes Yes Yes Yes Were any co-interventions identified that may influence Yes Yes Yes No No No No the outcomes for each group? Were the outcome assessors blinded to the treatment No Not reported Not reported No Not reported No Not reported allocation? Were the individuals who administered the No No Not reported No Not reported No Yes intervention blinded to the treatment allocation? Were the participants who received the intervention No No Not reported No No No Yes blinded to the treatment allocation? Was the success of the blinding procedure assessed? NA NA Not reported NA Not reported NA Not reported Were at least 80% of the participants originally Yes Yes Yes Yes Yes Yes Yes included in the randomisation process followed up in the final analysis? Were the reasons for withdrawals stated? Yes Yes Yes No Yes No Yes Was an intention-to-treat analysis included? Yes Yes Yes Yes (1 patient Yes Yes Yes not included) NA, not applicable.
Using the method proposed by Bucher and colleagues. 63 and adapted from Song and colleagues, 62 an adjusted indirect comparison was undertaken to estimate the efficacy of docetaxel plus prednisone versus prednisone alone in improving overall survival for men with HRPC. Using the adjusted indirect method means that the power of randomisation in the original studies is maintained. However, this method is only valid when the magnitude of the treatment effect is consistent between the different studies being compared. The estimate of the adjusted indirect comparison is given by T BC = T BA – T CA where T BA is the treatment effect for intervention B versus intervention A, T CA is the treatment effect for intervention C versus intervention A and T BC is the indirect comparison of interest, the estimate of the treatment effect of intervention B versus intervention C. The estimate of the standard error of the estimate of the indirect treatment effect, T BC, is given by SE(TBC) = √ –––––––––– SE(TBA) 2 + SE(TCA) 2 ––––––––––– where SE(T BA) and SE(T CA) are the standard errors of T BA and T CA, respectively. Worked example: docetaxel plus prednisone versus prednisone (overall survival) Using the adjusted method, the treatment effect (T BC) of overall survival for docetaxel plus prednisone versus prednisone can be calculated using mitoxantrone plus prednisone as a common comparator between trials. In this example: Interventions: A = mitoxantrone plus prednisone B = docetaxel plus prednisone (3-weekly) C = prednisone Appendix 8 Health Technology Assessment 2007; Vol. 11: No. 2 Adjusted indirect comparisons © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Treatment effects: T BA = HR for death; docetaxel plus prednisone versus mitoxantrone plus prednisone T CA = HR for death; prednisone versus mitoxantrone plus prednisone There is an estimate from TAX 327 27 of T BA = 0.76 (95% CI: 0.62 to 0.94). Using the random effects pooled estimate calculated in the section ‘Pooled estimate of effectiveness of mitoxantrone plus a corticosteroid versus a corticosteroid’ (p. 34) an HR for death = 0.99 (95% CI: 0.82 to 1.20) for mitoxantrone plus prednisone versus prednisone. However in order to perform the adjusted indirect comparison, mitoxantrone plus prednisone is used as the common comparator, so this figure must be inverted to give an estimate of prednisone versus mitoxantrone plus prednisone; T CA = 1.01 (95% CI: 0.83 to 1.22). In order to use the adjusted indirect comparison technique, the ln (HR)s and corresponding standard errors must be used in the calculations. The results of these calculations can then be converted back to HRs and standard errors (using antilog transformations), for ease of interpretation. Therefore, using the adjusted method and the ln(HR)s and standard errors, the treatment effect for docetaxel plus prednisone versus prednisone for overall survival is given by lnT BC = lnT BA – lnT CA = –0.274 – 0.01 = –0.284 The standard error is SE(lnT BC) = √ ––––––––––––––––––––––––– SE(lnT BA) 2 + SE(lnT CA) 2 = √ ––––––––––––––––––––––– 0.106 2 + 0.321 2 = 0.338 According to this estimate, the 95% CI for lnT BC is: –0.284 ± (1.96 × 0.338) = –0.568 to –0.0009 After anti-log transformations, we have a treatment effect of overall survival for docetaxel plus prednisone versus prednisone; HR for death = 0.752 (95% CI: 0.567 to 0.999). 159
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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
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Effectiveness of mitoxantrone plus
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over to receive additional mitoxant
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Progression-free survival It is not
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compared with corticosteroids. The
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statistically significant improveme
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Summary of studies included in the
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TABLE 19 Percentage of costs by res
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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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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
Page 175: Study details and Participant detai
Page 181 and 182: Appendix 9 © Queen’s Printer and
Page 183 and 184: Sanofi-Aventis 61 Bloomfield et al.
Page 185: Sanofi-Aventis 61 Bloomfield et al.
Page 188 and 189: 168 Appendix 10 TABLE 51 Mean (SD)
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Page 192 and 193: 172 Appendix 10 TABLE 57 Mean stand
Page 194 and 195: 174 Appendix 11 TABLE 63 Drug and a
Page 196 and 197: 176 Appendix 12 Scenario: moderate
Page 198 and 199: 178 Appendix 13 ● You occasionall
Page 202 and 203: Members Chair, Professor Tom Walley
Page 204 and 205: Members Chair, Professor Bruce Camp
Page 207: Feedback The HTA Programme and the
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