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

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134 Appendix 6 Study details and Participant details Intervention details Results Conclusion and design comments Median time on primary treatment: I(1): 20.4 months (95% CI: 17.5 to 23.3) I(2): 19.2 months (95% CI: 15.7 to 22.8) C: 11.6 months (95% CI: 7.1 to 16.2) p = 0.003 Relative event rates for time on primary treatment: I(1) vs C: 0.49 (95% CI: 0.25 to 0.97) I(2) vs C: 0.39 (95% CI: 0.20 to 0.76) I(1) vs I(2): 1.26 (95% CI: 0.78 to 2.04) p = 0.0005 Exploratory analysis: Survival of patients in C receiving salvage therapy of docetaxel: 31.7 months (95% CI: 26.4 to 36.9 months) Survival of patients in C receiving no further therapy or nondocetaxel chemotherapy: 7.5 months (95% CI: 4.9 to 10.1 months)
Study details and Participant details Intervention details Results Conclusion and design comments Authors’ conclusions: The improvement in median survival of nearly 2 months with docetaxel and estramustine, compared with mitoxantrone plus prednisone, provides support for this approach in men with metastatic androgen-independent prostate cancer Outcome 1: Overall survival Time from the date of randomisation to the date of death from any cause or censored at the date of last contact Number randomised: 770 men, 674 eligible Authors: Petrylak et al., 2004 29 Country: USA Median survival. (N = 674): I: 17.5 months (p = 0.02) C: 15.6 months HR for death: 0.80 (95% CI: 0.67 to 0.97) Intervention: 280 mg estramustine 3 × daily on days 1–5, +60 mg docetaxel per m 2 body surface area i.v. on day 2, preceded by 60 mg dexamethasone orally in 3 doses Sites of disease: Bone: I = 84%; C = 88% Lymph node: I = 24%; C = 26% Liver: I = 8%; C = 9% Lung: I = 10%; C = 10% Primary source: Handsearching After median follow-up of 32 months: I: 217/338 (64%) died C: 235/336 (70%) died Disease characteristics: SWOG performance status: I: 0–1 = 90%; 2–3 = 10% C: 0–1 = 88%; 2–3 = 12% PSA (ng/ml), median (range): I: 84 (0.1–10,820) C: 90 (0.1–8,378) Aim: To determine whether docetaxel plus estramustine improves survival over that afforded by mitoxantrone plus prednisone in men with androgenindependent prostate cancer Bone pain, grade
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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
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
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
Page 153: Study details and Participant detai
Page 175: Study details and Participant detai
Page 178 and 179: 158 Appendix 7 Ernst et al. 33 Qual
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)
Page 190 and 191: 170 Appendix 10 TABLE 54 Distributi
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
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Members Chair, Professor Bruce Camp
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Feedback The HTA Programme and the
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