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

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144 Appendix 6 Study details and Participant details Intervention details Results Conclusion and design comments Assessment at baseline and 1 subsequent visit for 111 patients: Decrease I: n (%) C: n (%) ≥ 25% 28 (49) 25 (46) ≥ 50% 19 (33) 12 (22) ≥ 75% 13 (23) 5 (9) p = 0.11. Sensitivity analysis effect of PSA response on palliative response (from Dowling et al. 45 ): PSA response Palliative No palliative response response I C I C ≥ 50% 18 1 9 8 Stable 9 9 17 14 Primary non-responder 2 6 13 20 Unevaluable 1 1 11 22 p = 0.001. Outcome 5: Adverse events Assessed by WHO criteria Minimal toxicity attributable to prednisone. Toxicity attributable to mitoxantrone, including patients crossed over to this treatment (total = 130 patients; 796 courses): Hematological toxicity: Granulocyte nadir × 10 9 /l: 0.5–1.0: 171 courses (32%)
Study details and Participant details Intervention details Results Conclusion and design comments heart failure, 1 also had atrial fibrillation Nausea and vomiting: assessed for 654 cycles in 120 patients (including crossover): None: 71% cycles WHO grade 3–4: 3 cycles (0.5%) Alopecia: None: 90 (76%) Remainder: minimal/patchy loss Outcome 6: Pain Pain measured on 3 scales (N = 138) Data from Stockler et al.: 48 Differences between I and C (all favour I) in measures of pain: median (95% CI) LASA: 11 (2–20) p = 0.014 QLQ-C30: 8 (0–17) p = 0.027 PPI: 0 (0–20) p = 0.088 © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Mean (95% CI) LASA: 13 (3 to 22) p = 0.010 QLQ-C30: 11 (2 to 20) p = 0.023 PPI: 8 (1 to 15), p = 0.030 Health Technology Assessment 2007; Vol. 11: No. 2 Outcome 7: HRQoL Pain intensity scales completed for 92% clinic visits during initial treatment, LASA scales for pain on 89% visits. 78 patients in I assessed; 76 in C (N = 154): Scales with significant differences: Pain: LASA median changes (p = 0.01) LASA best changes (p = 0.01) EORTC median changes (p < 0.05) EORTC best changes (p < 0.05) Constipation: LASA median changes (p < 0.05) LASA best changes (p < 0.05) EORTC best changes (p < 0.05) continued 145
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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
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 163: 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
Page 204 and 205: Members Chair, Professor Bruce Camp
Page 207: Feedback The HTA Programme and the
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