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

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132 Appendix 6 Study details and Participant details Intervention details Results Conclusion and design comments Median duration of PSA response, in months (defined as the time interval between the first 50% decline in PSA levels until PSA increased to 50% above the nadir): Protocol deviations: 3 patients never started treatment (1 stroke and 2 withdrawals of consent) Other previous anticancer therapy: I(1) I(2) C n (%) n (%) n (%) Per protocol analysis performed: Not stated I(1), 8; I(2), 8.3 ; C, 6.4 Outcome 5: Adverse events (n = 127) Scored according to the revised NCI CTC, version 1. Surgery 6 10 8 (14) (24) (19) Radiotherapy 10 9 7 (23) (21) (17) Severe adverse events (grade 3 or 4): I(1): n (%) I(2): n (%) C: n (%) Median age of participants: I(1), 68; I(2), 68; C, 70 years Granulocytopenia 16 (37) 0 20 (48) Granulocytopenic 0 0 3 (7) fever Anaemia 1 (2) 0 3 (7) Thrombocytopenia 0 1 (2) 1 (2) Nausea 1 (2) 0 0 Vomiting 1 (2) 0 0 Diarrhoea 3 (7) 0 0 Thrombosis (caused by estramustine) 3 (7) 3 (7) 0 Age IQ range of participants: I(1), 52–91; I(2), 51–79; C, 52–85 Comments: A Simon design was used to calculate that a sample size of 130 was required to distinguish a 60% PSA response from a 30% response with 80% power and a Type 1 error of 0.05 Other participant characteristics: Time from diagnosis to random assignment (median months, IQ range): I(1): 33, 3–219 I(2): 33, 5–151 C: 47, 6–150 I(1): 1 corticosteroid premedication-related death reported Baseline comparability: Yes, non-significant trend for I(2) to have better ECOG performance status (p = 0.18) Other adverse events: Asthenia: Time from start of hormonal treatment to random assignment (median months, IQ range): I(1): 16, 2–116 I(2): 27, 2–89 C: 25, 1–118 Eligibility criteria specified: Yes I(1), 47%; I(2), 41%; C, 26% p = 0.30 Nail and skin toxicities: I(1) + I(2): 14% Decrease in LVEF (grade 1 or 2): C: 4 (10%) Comments about participants: Inclusion/exclusion criteria: Histologically proven metastatic adenocarcinoma of the prostate with progressive disease, despite androgen deprivation. Anti-androgen withdrawal and documented disease progression were required before study entry. Disease progression was defined as appearance of new Co-interventions: Premedication with oral prednisolone, 300 mg total dose and oral warfarin 2 mg/day administered continuously in I(1) and I(2) Outcome 6: Pain (n = 127) ‘Clinical benefit’ was measured using the pain control and analgesic consumption indices of the McGill pain questionnaire and ECOG performance status. Pain control was scored from 0 (no pain) to 4 (uncontrollable pain) and the analgesic consumption was scored from 0 (no requirement) to 4 (regular, narcotic analgesic use). Clinical From Oudard et al.: 38,39 coumadin (2 mg orally) given continued
Study details and Participant details Intervention details Results Conclusion and design comments benefit was defined as reduction by at least 1 in the pain index and/or performance status improvement by at least 1 continuously to all patients I(1): n (%) I(2): n (%) C: n (%) Pain control 10 (23) 9 (21) 7 (17) Analgesic consumption 15 (35) 10 (24) 6 (14) Improved pain index 17 (40) 12 (29) 7 (17) 1 + 2 Improved ECOG 26 (60) 20 (48) 12 (28) a Improved clinical 14 (33) 10 (24) 9 (21) benefit 3 + 4 lesion(s), and/or an increase of ≥ 25% of measurable metastases, and/or the appearance of new foci on a radionuclide bone scan, and/or 3 consecutive increases in PSA at least 1 week apart in the presence of testosterone castrate level of metastatic patients. Patients were ineligible if they had received prior chemotherapy (including estramustine), and at least 4 weeks had to have elapsed since completion of radiation, or last dose of a therapeutic radionuclide, and prior flutamide or nilutamide. Six weeks had to have elapsed since prior bicalutamide. Patients were also required to have life expectancy at least 3 months, ECOG performance score of 0 to 2 and no uncontrolled diabetes or other comorbidities that might limit survival Blinding: Outcome assessor: Not stated Carer: no Patient: no Success assessed: Not applicable 80% Follow-up: Yes © Queen’s Printer and Controller of HMSO 2007. All rights reserved. a p = 0.01 Outcome 7: HRQoL Not reported Withdrawals: 3 patients randomised were never treated, 1 had a stroke before first cycle of treatment and 2 withdrew their consent Discontinuations: 4 patients were taken off therapy due to severe adverse side-effects Health Technology Assessment 2007; Vol. 11: No. 2 Median relative dose-intensities: I(1), docetaxel: 1.0 (range: 0.58–1.07) I(2), docetaxel: 0.98 (range: 0.50–1.11) C, mitoxantrone: 0.97 (range: 0.33–1.17) Median cumulative dose: I(1): 414 mg/m 2 (range: 69 to 429) I(2): 403 mg/m 2 (range: 66 to 423) C: 66 mg/m 2 (range: 10 to 76) The estramustine cumulative doses were similar in the docetaxel arms Dose reductions required in 2.4% of patients [2 in I(1), 1 in C] Level of crossover: I(1), 16%; I(2), 10%; C, 48% p = 0.00001, between groups Patients were also required to have a castrate level of testosterone (
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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
Page 101: 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 151: 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
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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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