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

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136 Appendix 6 Study details and Participant details Intervention details Results Conclusion and design comments Outcome 4: PSA decline PSA decline of ≥ 50% (N = 612) I: 155/309 (50%) C: 82/303 (27%) (p < 0.001) Outcome 5: Adverse events Adverse events (measured using the NCI CTC, version 2; grade 3 (severe)/4 (life-threatening)/5 (fatal) (N = 658): I (n = 330) C (n = 328) Control: 12 mg mitoxantrone per m 2 body surface area i.v. on day 1, + 5 mg prednisone 2 × daily. Given in 21-day cycles. Dose of mitoxantrone increased to 14 mg/m 2 if no grade 3–4 adverse events during first cycle. Treatment continued until disease progression or unacceptable adverse events, or until 144 mg/m 2 mitoxantrone administered Age range of participants: I, 47–88 years; C, 43–87 years Other participant characteristics: Race: White: I, 86%; C = 82% Black: I = 12%; C = 15% Hispanic: I = 7%; C = 6% Asian: I = 1%; C = 1% Unknown: I = 1%; C = 1% Comments about participants: Patients were stratified by type of progression (measurable vs PSA alone), grade of bone pain (mild, moderate, severe, disabling) and SWOG performance-status (0–1 vs 2–3) Drug reaction 0/0/3 0/0/3 Cardiovascular a 37/10/1 16/6/0 Clotting 2/0/0 0/0/0 Dermatological 1/0/0 1/0/0 Endocrine 0/0/0 1/0/0 Influenza-like 29/3/0 20/2/0 Nausea/vomiting a 61/5/0 16/1/0 Haematological 17/47/1 18/33/0 Haemorrhage 11/2/1 6/0/0 Immunological 3/0/0 0/0/0 Infection a 36/7/2 20/2/0 Liver 9/1/1 11/1/0 Lung 12/2/1 8/1/1 Metabolic a 14/6/0 2/0/0 Musculoskeletal 8/0/0 1/2/0 Neurological a 21/2/0 5/0/0 Pain 34/1/0 18/5/0 Renal/bladder 8/0/1 3/0/0 Max. grade of any a 114/62/8 63/46/4 Inclusion/exclusion criteria: Pathologically confirmed adenocarcinoma of the prostate and progressive metastatic disease (stage D1 or D2) despite androgen-ablative therapy and cessation of antiandrogen treatment ITT analysis performed: Yes No. randomised: 384 (336 eligible) Route of administration: Mitoxantrone, i.v.; prednisone, not reported Dose: 12–14 mg/m 2 mitoxantrone No. of cycles: 12 Length per cycle: 21 days Per protocol analysis performed: Not stated Criteria for progressive disease were progression of a bi-dimensionally measurable lesion, as assessed within 28 days before study registration; progression of disease that could be evaluated but not measured (e.g. by bone scanning), as assessed within 42 days before registration; or an increase in serum PSA level over the baseline level in at least two consecutive samples obtained at least 7 days apart Comments: Baseline comparability: Adequate Comments about intervention/control: a = p < 0.005. The rate of grade 3, 4 or 5 neutropenia in the docetaxel group did not differ significantly from that in the mitoxantrone group (16.1% versus 12.5%; p = 0.22). However, the docetaxel group had significantly higher rates of grade 3 or 4 neutropenic fevers (5% versus 2%; p = 0.01) Protocol deviations: Warfarin and aspirin were added to the intervention group due to a report that prophylactic anticoagulation decreased estramustine-associated vascular effects (15 January 2001). Numbers of patients enrolled Adequate renal, hepatic and cardiac function and a SWOG performancestatus score of 0–2 (3 was allowed if due to bone pain) were also required Patients were ineligible if they had received prior radioisotope or anticoagulant therapy (excluding Eligibility criteria specified: Yes Co-interventions: Premedication with dexamethasone was given in the intervention group. The intervention group was also given warfarin and aspirin after a protocol change on 15 January 2001. To ensure continued androgen ablation, continued
Study details and Participant details Intervention details Results Conclusion and design comments There were eight treatment-related deaths in the docetaxel group and 4 in the mitoxantrone group Outcome 6: Pain No significant difference (data not shown) before/after this date not reported. Enrolment from October 1999 to January 2003 aspirin), had active thrombophlebitis or hyper-coagulability, had a history of pulmonary embolus or pleural effusions or ascites Outcome 7: HRQoL Not reported patients continued taking luteinising hormone-releasing hormone agonists throughout study treatment Withdrawals: I: 48 (not eligible) 54/338 (16%) due to adverse events C: 48 (not eligible) 32/336 (10%) due to adverse events Discontinuations: Six patients who discontinued treatment within 1 week after starting I (2) or C (4) were not included in the evaluation of adverse events There were 11 major protocol deviations. Six in I and 4 in C did not receive the assigned treatment and were not included in the evaluation of adverse events. One man received intermittent radiotherapy while on C; he was included in the evaluation of adverse events Blinding: Outcome assessor: Not stated Carer: Not stated Patient: Not stated Success assessed: No 80% Follow-up: Yes © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Health Technology Assessment 2007; Vol. 11: No. 2 137
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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
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 155: 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
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Feedback The HTA Programme and the
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