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

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140 Appendix 6 Study details and Participant details Intervention details Results Conclusion and design comments Outcome 6: Pain Not reported Per protocol analysis performed: Not stated Outcome 7: HRQoL Not reported Discontinuations: Not stated Patients were also required to have adequate pretreatment liver and cardiac function and ECOG performance status of 0–2. No other malignancy in last 5 years, parenchymal brain metastases, prior immunotherapy, prior chemotherapy or concurrent use of exogenous corticosteroids Comments: All patients given at least 1 dose included in analysis of safety. Study did not allow for crossovers Baseline comparability: Yes Eligibility criteria specified: Yes Cointerventions: Anti-androgens where previously given. All other forms of hormone therapy were disallowed Blinding: Outcome assessor: No Carer: No Patient: No Success assessed: NA 80% Follow-up: Yes
Study details and Participant details Intervention details Results Conclusion and design comments Authors’ conclusions: Chemotherapy with mitoxantrone plus prednisone provides palliation for some patients with symptomatic HRPC Outcome 1: Overall survival (N = 161) No significant difference in overall survival; 140 total deaths (p = 0.27, favouring I group) Number randomised: 161 Disease characteristics: Sites of metastasis: Authors: Tannock et al., 1996 31 Country: Canada From Moore et al.: 49 Median survival was 10 months, with no difference between I and C (p = 0.15, favouring I) Site I: n (%) C: n (%) Primary source: MEDLINE Comments: Supported by Lederle Laboratories, Division of Cyanamid Canada Inc. Univariate regression analysis for time to death (from Dowling et al. 45 ): Intervention: Mitoxantrone + prednisone No. randomised: 80 Route of administration: Mitoxantrone, i.v.; prednisone, orally Dose: mitoxantrone, 12 mg/m 2 every 3 weeks; prednisone, 5 mg b.d. Bone 78 (98) 77 (95) Lymph 18 (22) 15 (19) Visceral 3 (4) 3 (4) Other 7 (9) 8 (10) Variable p HR (95% CI) PSA concentration: median (interquartile range) I, 209 (66–678); C, 158 (42–548) Aim: To investigate the benefit of chemotherapy in patients with symptomatic HRPC using relevant endpoints of palliation An independent external consultant (from National Cancer Institute of Canada) reviewed records of all responding patients and a randomly selected series of additional patients Older age 0.26 1.01 (0.99 to 1.03) Increasing ECOG
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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.
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 159: 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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