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

More documents

Recommendations

Info

28 Results TABLE 10 Summary results table for mitoxantrone plus prednisone versus prednisone lesions or a requirement for radiotherapy. Pain was assessed using the PPI scale from the McGill–Melzack questionnaire. Scores range from 0 to 5, with higher scores indicating more pain. Analgesic use was assessed using a diary and an analgesic score was calculated by assigning a score of 1 for a standard dose of a non-narcotic analgesic and 2 for a standard oral dose of a narcotic. The analgesic scores were averaged for the last 7 days of each 21-day cycle. Data on time to progression were available for 147 participants from the approval package. 20 At the time of analysis, treatment had failed for 43 participants in the mitoxantrone group and for 60 in the prednisone group. There was a statistically significant benefit in terms of time to progression for those in the mitoxantrone group over those in the prednisone group: estimated HR for time to progression (calculated from numbers of events and p-value presented in the trial publication) = 2.15 (95% CI: 1.46 to 3.17, p = 0.0001). The median time to progression was 148 days for those in the mitoxantrone group and 62 days for those in the prednisone group. Response rate The primary outcome for this trial was palliative response, defined as a two-point improvement in pain score without an increase in analgesic score maintained for two consecutive visits, at least 3 weeks apart. Those participants with a baseline pain score of ≤ 1 were required to have a complete reduction in pain score. A secondary criterion for palliative response was defined as a 50% or more decrease in analgesic score without an increase in pain score. Mitoxantrone group Prednisone group Comparison a Mortality 43/56 (77%) 48/63 (76%) HR = 1.13 (95% CI: 0.75 to 1.7) Progression-free survival HR = 0.64 (95% CI: 0.48 to 0.86) Response rate 2/8 (25%) 2/9 (22%) RR = 1.13 (95% CI: 0.20 to 6.24) QoL response Not reported Pain response Not reported PSA decline Adverse events: 27/56 (48%) 15/63 (24%) RR = 2.03 (95% CI: 1.21 to 3.40) Discontinued Not reported Not reported Grade 3/4 Not evaluable Not evaluable Died 0 0 a All comparisons are mitoxantrone + prednisone versus prednisone, so HR
Also used was the core questionnaire with 30 ordinal scale items including assessment of various domains associated with QoL, from the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30), with scores ranging from 0 to 100, with 100 indicating excellent quality of life. This latter instrument was supplemented by a trial-specific questionnaire, the QOLM-P14, with scores ranging from 0 to 100, with higher scores indicating more severe symptoms. A total of 71 patients receiving mitoxantrone were included in the analyses of HRQoL as reported by Osoba and colleagues. 46 These analyses showed that compared with baseline, this group experienced significant improvements in physical functioning, social functioning, global QoL, pain, anorexia, constipation, impact of pain on mobility, degree of pain relief, and drowsiness (0.0001 of improvements ranged from 11 to 19 weeks. A total of 62 patients receiving prednisone were included in the analyses of HRQoL as reported by Osoba and colleagues. 46 These analyses showed that compared with baseline, this group experienced significant improvements in social functioning, global QoL, nausea and vomiting, anorexia (0.003 of pain on mobility (p = 0.01). The duration of improvements ranged from 3 to 7 weeks. A total of 35 patients receiving prednisone then crossing over to receive mitoxantrone were included in the analyses of HRQoL as reported by Osoba and colleagues. 46 These analyses showed that compared with baseline, this group experienced significant improvements in pain, insomnia and impact of pain on mobility (0.0001 of improvement ranged from 4 to 26 weeks. There was a statistically significant benefit for the mitoxantrone group compared with the prednisone group in terms of the duration of improvements of more than 10 points from baseline in social functioning, pain, impact of pain on mobility, pain relief, insomnia and drowsiness (0.004 the definitions of progression-free survival and response rate, data on pain have been reported under these headings (see above). PSA decline There were 57 patients in the mitoxantrone group and 54 patients in the © Queen’s Printer and Controller of HMSO 2007. All rights reserved. Health Technology Assessment 2007; Vol. 11: No. 2 prednisone group for whom at least two PSA measurements were recorded (one at baseline and at least one subsequent visit). There were no statistically significant differences with respect to PSA decline between the two groups; RR for PSA decline = 1.5 (0.807 to 2.787, p = 0.11). Of the 57 patients in the mitoxantrone group included in the analysis, 28 (49%) achieved a PSA decline of 25% or more; of these, 19 (33%) achieved a decline of at least 50% and 13 (23%) of these achieved a decline of 75% or more. Of the 54 patients in the prednisone group included in the analysis, 25 (46%) achieved a PSA decline of 25% or more; of these, 12 (22%) achieved a decline of at least 50% and five (9%) of these achieved a decline of 75% or more. Adverse effects of treatment Limited information on adverse effects of treatment was reported in the original trial publication. Only one patient randomised to the prednisone group was reported to have discontinued treatment due to toxicity. There were five patients in the mitoxantrone group who received cumulative doses of 116–214 mg/m 2 of mitoxantrone who developed cardiac abnormalities; however there were no deaths resulting from this. All 130 patients who received mitoxantrone therapy (including those who crossed over) were assessed using the WHO criteria for toxic side-effects. As data were reported in the FDA report 20 for the prednisone group prior to crossover, comparisons with the adverse effects of mitoxantrone can be made. Data on adverse effects of treatment presented in the approval package 20 indicate that there were 43 serious adverse events, either related or unrelated to study drugs, experienced by 37 patients, 22 in the mitoxantrone group and 15 in the prednisone group (seven of these patients had crossed over). Eleven patients in the mitoxantrone group withdrew from the trial due to toxicity and one patient randomised to receive prednisone alone withdrew due to toxicity after crossing over to receive mitoxantrone. Table 11 shows the proportion of patients experiencing grade 3 or 4 adverse events (presented in the FDA report). Summary Summary results are given in Table 12. CALGB 9182 32 Overall survival Overall survival was the primary end-point for the trial, defined as the time between randomisation and death; for living patients the survival time was censored at the time 29
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: TABLE 9 Grade 3 or 4 adverse events
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 and 144:
Appendix 6 Data extraction tables
Page 145 and 146:
Study details and Participant detai
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175:
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?