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

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130 Appendix 6 Study details and Participant details Intervention details Results Conclusion and design comments Authors’ conclusions: The results show significantly higher PSA decline (≤ 50%) and longer times to progression in patients with HRPC receiving docetaxel–estramustineprednisone based chemotherapy than mitoxantrone–prednisonebased chemotherapy, and that docetaxel–estramustine– prednisone basedchemotherapy could be proposed in this setting Outcome 1: Overall survival (n = 127) Defined as the time from study entry to death or date of last follow-up: Intervention 1: Docetaxel, estramustine + prednisone Number randomised: 130, 127 included in the analysis Author: Oudard et al., 2005 28 Disease characteristics (N = 127): I(1): 18.6 months (95% CI: 14.9 to 22.3) I(2): 18.4 months (95% CI: 14.1 to 22.8) C: 13.4 months (95% CI: 9.4 to 17.5) No. randomised: 44, 43 assessed Country: France (24 centres) ECOG performance status: I(1) I(2) C n = 43 n = 42 n = 42 Survival analysis was performed at 12 months median followup (95% CI: 10.1 to 13.8) when 99 deaths (78%) had occurred. 3-year survival was 22% for entire cohort Primary source: Handsearch (reference list of industry submission) Relative event rates: I(1) vs C: 1.08 (95% CI: 0.66 to 1.76) I(2) vs C: 0.75 (95% CI: 0.46 to 1.21) I(1) vs I(2): 1.43 (95% CI: 0.89 to 2.31) p = 0.13 0 17 25 20 (40%) (59%) (48%) 1 19 13 11 (44%) (31%) (26%) 2 7 4 11 (16%) (10%) (26%) Gleason score: Association of median overall survival with baseline characteristics (multivariate): Route of administration: Docetaxel, 1-hour i.v. infusion; estramustine, orally 2 hours after meals; prednisone, not stated Dose: docetaxel, 70 mg/m 2 on day 2 every 21 days; estramustine, 840 mg in 3 divided doses on days 1–5 and 8–12; prednisone, 10 mg daily No. of cycles: Not stated Length per cycle: 3 weeks I(1) I(2) C n = 43 n = 42 n = 42 Aim: to evaluate PSA response and safety of two docetaxelestramustine– prednisone schedules and one mitoxantrone– prednisone schedule Comments: two authors (including lead author) disclosed potential conflicts of interest with Aventis Baseline ECOG performance status: p = 0.0001 2–4 2 0 1 (5%) (2%) 5–6 10 5 10 (23%) (12%) (24%) 7–10 30 37 28 (70%) (88%) (67%) Unknown 1 0 3 (2%) (7%) Trial ID: – Baseline haemoglobin level: p = 0.006 Intervention 2: Docetaxel, estramustine + prednisone Phase: Phase II One of the additional abstracts identified 40 had conflicting results to the main trial report, therefore was not used for data extraction RR of death reduction (HR): I(1) and C: 6% (95% CI: –2 to 71%) I(2) and C: 14% (95% CI: –8 to 32%) Outcome 2: Progression-free survival Median time to progression (defined as the date of the first CT scan demonstrating a new lesion(s) or a ≥ 25% increase in the bi-dimensional measurements of previously measurable disease. For those with bone disease, new lesion(s) on radionuclide bone scan counted as disease progression No. randomised: 44, 42 assessed Route of administration: Docetaxel, 30-minute i.v. infusion; estramustine, orally 2 hours after meals; prednisone, not stated Dose: docetaxel, 35 mg/m 2 on days 2 and 9 every 21 days; estramustine, 840 mg in 3 divided doses on days 1–5 and 8–12; prednisone, 10 mg daily Tumour-related symptoms: I(1) I(2) C n (%) n (%) n (%) Median time for those with measurable disease: 11.5 months (95% CI: 6.9 to 16.9) Median time for those with bone disease only: 18.2 months (95% CI: 16.5 to 21.8) Outcome 3: Response rate (n = 127): Measurable disease response was defined in accordance with WHO guidelines No bone 12 12 11 pain (28) (29) (26) Bone pain 28 24 30 (65) (57) (72) Unknown 3 6 1 (7) (14) (2) Length of followup: Not stated Number and times of follow-up measurements: Patients were evaluated radiographically every 2 cycles and/or by radionuclide bone scan every 3 cycles and then every 3 months while in the study. Weekly complete blood continued
Study details and Participant details Intervention details Results Conclusion and design comments I(1): 9 responses [7 partial responses (PRs), 2 complete responses (CRs)] I(2): 3 responses (2 PRs, 1 CR) C: 1 response (1 CR) p = 0.01 [Bonferroni, p = 0.016 between I(1) and C] No. of cycles: Not stated Length per cycle: 3 weeks Analgesic use at entry: I(1) I(2) C n (%) n (%) n (%) Outcome 4: PSA decline [n = 123, 1 patient in I(2), 3 in C not evaluated due to baseline PSA < 4 ng/ml] (Primary outcome of trial) Treatment 24 21 25 (56) (50) (60) No treatment 16 14 16 (37) (33) (38) Unknown 3 7 1 (7) (17) (2) PSA decrease (≥ 50%) was documented in accordance with the guidelines of the PSA Working Group: count (CBC) and 3-weekly PSA levels were measured during treatments. Pain control and analgesic consumption were self-reported using pain diaries and medication records were checked I(1) I(2) C 29 (67%) 26 (63%) 7 (18%) 22 (51%) 16 (39%) 3 (8%) 10 (23%) 7 (17%) 1 (2%) Serum PSA (ng/ml), median (IQ range): I(1): 71 (1.9–2818) I(2): 69.5 (0.01–2416) C: 77.7 (0.41–1840) ≥ 50% a ≥ 75% a Normalisation b (
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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 149: 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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