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

More documents

Recommendations

Info

124 Appendix 6 Study details and Participant details Intervention details Results Conclusion and design comments Authors’ conclusions: When given with prednisone, treatment with docetaxel every 3 weeks led to superior survival and improved rates of response in terms of pain, serum PSA level and QoL compared with mitoxantrone plus prednisone Outcome 1: Overall survival Time from the date of randomisation to the date of death from any cause or censored at the date of last contact Authors: Tannock et al., 2004 27 Median survival (n = 1006): I(1): 18.9 months (95% CI: 17.0 to 21.2) I(2): 17.4 months (95% CI: 15.7 to 19.0) C: 16.5 months (95% CI: 14.4 to 18.6) From Eisenberger et al.: 36 I(1) + I(2): 18.3 months Number randomised: 1006 men Disease characteristics: Gleason score: I(1): ≤ 7 = 42%; 8–10 = 31%; unavailable = 26% I(2): ≤ 7 = 40%; 8–10 =31%; unavailable = 29%. C: ≤ 7 = 42%; 8–10 = 28%; unavailable = 30% Karnofsky performance status score (60–70%): I(1), 13%; I(2), 12%; C, 14% Country: 24 countries, including Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Finland, France, Germany, Hungary, Italy, Lebanon, The Netherlands, Poland, Russia, Slovak Republic, South Africa, Spain, Sweden, UK, USA Comments: The study was supported by Aventis, with consulting fees from Aventis received by most of the authors. Aventis also collected and maintained the data and undertook the statistical analysis, but the final content of the article was determined by the investigators HR for death: I(1) vs C: 0.76 (95% CI: 0.62 to 0.94, p = 0.009) I(2) vs C: 0.91 (95% CI: 0.75 to 1.11, p = 0.36) [I(1) + I(2) vs C: 0.83 (95% CI: 0.70 to 0.99, p = 0.04) 36 ] PSA (ng/ml), median (≥ 20 ng/ml, %): I(1), 114 (87); I(2), 108 (84); C, 123 (89) The analysis was planned after 535 deaths had occurred: I(1): 166/335 (50%) died I(2): 190/334 (57%) died C: 201/337 (60%) died Pain present (PPI score ≥ 2 or analgesic score of ≥ 10): I(1), 45%; I(2), 45%; C, 46% Primary source: Handsearching HRs adjusted using a backward selection model, eliminating non-significant factors at p < 0.10, comprising: age (2), prior estramustine (yes vs no), presence of rising PSA alone vs presence of other indications of progression, baseline haemoglobin level, baseline serum level of alkaline phosphatase. Visceral involvement, high baseline alkaline phosphatase level and a low haemoglobin level were negative prognostic factors, whereas a rising serum PSA level as the sole indicator of progression was a favourable factor Intervention 1: 75 mg docetaxel per m 2 i.v. (for 1 hour) on day 1 every 21 days + 5 mg prednisone (or prednisolone, if prednisone unavailable) orally twice daily from day 1 + 8 mg dexamethasone given 12, 3 and 1 hour before docetaxel infusion. Up to 10 cycles of treatment were planned, and treatment delays of up to 2 weeks and up to 2 dose reductions were allowed. Dose reductions were required in the presence of grade 4 neutropenia for at least 7 days, an infection, or grade 3–4 neutropenia with an oral temperature ≥ 38.5°C. Dose reduction or treatment delay was also stipulated for patients with an absolute neutrophil count of
Study details and Participant details Intervention details Results Conclusion and design comments Subgroup: overall survival according to further chemotherapy [I(1) vs C] No further chemotherapy: I(1), n = 156; C, n = 171 HR = 0.745 (95% CI: 0.554 to 1.001) Hormonal manipulations: I(1): 1 = 9%; 2 = 68%; >2 = 23% I(2): 1 = 8%; 2 = 72%; >2 = 21% C: 1 = 6%; 2 = 69%; >2 = 25% Further chemotherapy: I(1), n = 179; C, n = 166 HR = 0.815 (95% CI: 0.608 to 1.092) HR stratified for baseline pain and Karnofsky performance Prior treatment with corticosteroids was permitted. Four weeks must have elapsed since prior surgery or radiotherapy and enrolment. At least 4 weeks had to have elapsed since taking anti-androgens (6 weeks for bicalutamide) and enrolment Outcome 2: Progression-free survival Not reported Number and times of follow-up measurements: Physical examinations and blood tests: every 3 weeks. Imaging studies: intervals of 6–9 weeks and repeated after 4 weeks to confirm responses Median age of participants: I(1), 68; I(2), 69; C, 68 years Outcome 3: Response rate Tumour response: evaluated with use of WHO criteria Number evaluated (N = 412) I(1), 141; I(2), 134; C: 137 Age range of participants: I(1), 42–92; I(2), 36–92; C, 43–86 years Other participant characteristics: Extent of disease: © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Response rate: I(1),12% (95% CI: 7 to 19, p = 0.11) I(2), 8% (95% CI: 4 to 14, p = 0.59) C, 7% (95% CI: 3 to 12) Outcome 4: PSA decline ≥ 50% reduction from baseline in PSA levels maintained for at least 3 weeks Method of randomisation: Assignment/ allocation: Centralised, permuted-block allocation, stratified by baseline pain level (present: median PPI score ≥ 2 or mean analgesic score ≥ 10 vs absent: median PPI
Page 1 and 2:
A systematic review and economic mo
Page 3 and 4:
A systematic review and economic mo
Page 5 and 6:
Objectives: A systematic review was
Page 7 and 8:
Glossary and list of abbreviations
Page 9 and 10:
Glossary Absolute risk reduction Th
Page 11 and 12:
Glossary continued Expected value o
Page 13 and 14:
Glossary continued Progression-free
Page 15:
List of abbreviations ASCO American
Page 18 and 19:
xvi Executive summary of study desi
Page 20 and 21:
xviii Executive summary prednisone/
Page 23 and 24:
Description of underlying health pr
Page 25 and 26:
● Patients with severe fluid rete
Page 27 and 28:
Search strategy As stated in Chapte
Page 29 and 30:
consensus and, if necessary, a thir
Page 31 and 32:
Quantity of research available A to
Page 33 and 34:
TABLE 1 Summary of included RCTs St
Page 35 and 36:
TABLE 2 Treatment comparisons relat
Page 37 and 38:
tumour response was reported for on
Page 39 and 40:
TABLE 4 Summary results table for d
Page 41 and 42:
decrease in PSA level (51 and 39% c
Page 43 and 44:
Survival (%) 100 80 60 40 20 0 0 co
Page 45 and 46:
TABLE 8 Summary results table for d
Page 47 and 48:
TABLE 9 Grade 3 or 4 adverse events
Page 49 and 50:
Also used was the core questionnair
Page 51 and 52:
these, 69 patients had measurable t
Page 53 and 54:
Effectiveness of mitoxantrone plus
Page 55 and 56:
over to receive additional mitoxant
Page 57 and 58:
Progression-free survival It is not
Page 59 and 60:
compared with corticosteroids. The
Page 61 and 62:
statistically significant improveme
Page 63 and 64:
Summary of studies included in the
Page 65 and 66:
TABLE 19 Percentage of costs by res
Page 67 and 68:
TABLE 21 Summary of submission by S
Page 69 and 70:
TABLE 24 Other in-trial costs a bod
Page 71 and 72:
TABLE 27 Cost-effectiveness results
Page 73 and 74:
Introduction The review of cost-eff
Page 75 and 76:
TABLE 28 Regression coefficients fr
Page 77 and 78:
cancer QoL estimation. Studies whic
Page 79 and 80:
Localised Metastatic mHRPC Bennet (
Page 81 and 82:
TABLE 34 Unit costs of drugs from t
Page 83 and 84:
were assigned to the total follow-u
Page 85 and 86:
Probability cost-effective given da
Page 87 and 88:
Probability cost-effective given da
Page 89 and 90:
TABLE 43 Utility values including/e
Page 91 and 92:
was set to be 1.5 years based on th
Page 93: Population value of implementation/
Page 96 and 97: 76 Discussion (CCI-NOV22) and least
Page 98 and 99: 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: Appendix 6 Data extraction tables
Page 147 and 148: 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
show all

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

Create successful ePaper yourself

Delete template?

Save as template?