Clinical Practice Guidelines for the management of locally advanced ...

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hydrocortisone respectively. Tannock et al documented that treatment with mitoxantrone resulted in a significant improvement in pain, quality of life and PSA response. There was no survival benefit although this was not a study endpoint. Kantoff et al reported similar outcomes. Subsequently, two pivotal large multicentre phase III studies 14,20 have demonstrated a survival benefit while maintaining improvements in quality of life for patients receiving docetaxel-based chemotherapy for their CRPC. These two studies form the basis for the current standard of care in Australia, docetaxel chemotherapy for CRPC. Tannock et al (TAX 327 study) enrolled 1006 patients who were randomly assigned to docetaxel 30mg/m 2 weekly for five of every six weeks, docetaxel 75mg/m 2 every three weeks or mitoxantrone 12mg/m 2 every three weeks. 14 All patients received 5mg bd of prednisolone. GnRH was continued. The majority of patients were Karnofsky performance score >70 and nearly half were asymptomatic. Up to ten cycles were planned for mitoxantrone and the three-weekly docetaxel group where median cycles completed were 5 and 9.5 respectively. Median survival was superior in the three-weekly docetaxel arm compared with mitoxantrone arm (18.9 months and 16.5 months; p=0.009). Threeweekly docetaxel also led to better pain control (35% versus 22%; p = 0.01), improvement in quality of life (22% improvement versus 13 % improvement; p=0.005) and PSA decline of >50% (48% vs 32% P
Evidence summary Level References Mitoxantrone and steroids offers better pain relief and quality of life than steroids alone. Docetaxel and prednisone is associated with better survival, pain relief and quality of life than mitoxantrone and prednisone. Compared with mitoxantrone and prednisone, docetaxel and estramustine improves survival without any effect on quality of life or pain. In comparison to mitoxantrone, docetaxel causes more grade 3 or 4 neutropenia, fatigue, alopecia, nail changes, diarrhoea, stomatitis, tearing, sensory neuropathy, dyspnoea, changes in taste and peripheral oedema. Mitoxantrone causes more impairment in left ventricular function than docetaxel. Docetaxel and estramustine in combination cause more cardiovascular events, neutropenic fevers, neurologic and metabolic disturbances and nausea and vomiting than mitoxantrone and prednisone. Recommendation: II 62, 63 II 14 II 20 II 14,18 Docetaxel in combination with prednisone is appropriate in the first line setting to improve survival, pain and quality of life in good performance patients with castrate-resistant metastatic prostate cancer. Grade B The combination of mitoxantrone and prednisolone also offers palliative benefit but no survival benefit compared to docetaxel. Grade C References 1. Scher HI, Halabi S, Tannock I et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008;26(7):1148-1159. 2. Di Silverio F, Sciarra F, D'Eramo G. Advanced prostatic cancer: clinical and hormonal response to flutamide in patients pretreated with LHRH analogue and cyproterone acetate. European Urology 18(1):10-5, 1990. 3. Fossa SD, Slee PH, Brausi M et al. Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European organization for research and treatment of cancer genitourinary group. Journal of Clinical Oncology 2001;(1):62-71. 4. Datta SN, Thomas K, Matthews PN. Is prednisolone as good as flutamide in hormone refractory metastatic carcinoma of the prostate? Journal of Urology 158(1):175-7, 1997. Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 90
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Clinical Practice Guidelines for th
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4 Biochemical relapse .............
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FOREWORD The management of prostate
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SUMMARY OF CLINICAL PRACTICE RECOMM
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SUMMARY OF RECOMMENDATIONS Chapter
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Chapter Recommendations Grade Refs
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1 INTRODUCTION 1.1 Natural history
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2 PSYCHOSOCIAL CARE The diagnosis a
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2.2 Effect of psychological and cog
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Evidence summary Level References T
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Recommendation Men with advanced pr
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An Australian cross-sectional study
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10. Dunn J, et al. A review of peer
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41. Sharpley CF, Christie DRH. An a
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different treatments from different
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Evidence summary Level References I
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Evidence summary Level References F
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Despite these reservations and the
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For non-metastatic disease there we
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Evidence summary Level References T
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monotherapy for low-to-intermediate
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Evidence summary Level References M
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for surgery, suggesting that surger
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Microscopic fully resected node pos
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All three trials demonstrated impro
Page 58 and 59: Evidence summary Level References B
Page 60 and 61: of an international multicentre ran
Page 62 and 63: 45. Melton LJ, III, Alothman KI, Kh
Page 64 and 65: 76. Little DJ, Kuban DA, Levy LB, Z
Page 66 and 67: 105. Thompson IM, Tangen CM, Parade
Page 68 and 69: 4.2 Androgen deprivation therapy (e
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Page 72 and 73: therapy since such studies would be
Page 74 and 75: apparent in trials comparing CAB wi
Page 76 and 77: QLQ instrument published by Cleary
Page 78 and 79: Note: Larger well-powered studies h
Page 80 and 81: Eight trials examined acute toxicit
Page 82 and 83: half of patients experienced pain r
Page 84 and 85: olus) in addition to radiotherapy a
Page 86 and 87: References 1. Seidenfeld J, Samson
Page 88 and 89: Cooperative Group. Scandinavian Jou
Page 90 and 91: Oncology Group, TROG 96.05). Radiot
Page 92 and 93: trial. European Journal of Cancer 1
Page 94 and 95: 6 CASTRATION-RESISTANT PROSTATE CAN
Page 96 and 97: the median overall survival for pat
Page 98 and 99: There are two points regarding bisp
Page 100 and 101: with bone pain at study entry. At n
Page 102 and 103: Recently, there have been reports o
Page 104 and 105: of these studies 56, 58 and in the
Page 106 and 107: Side effects (toxicity) As these ra
Page 110 and 111: 5. Manikandan R, Srirangam SJ, Pear
Page 112 and 113: 33. Elomaa I, Kylmala T, Tammela T
Page 114 and 115: 60. Janknegt RA, Abbou CC, Bartolet
Page 116 and 117: physiotherapists, occupational ther
Page 118 and 119: 7.5 Q2: Symptom control There was e
Page 120 and 121: Informal or family caregivers deriv
Page 122 and 123: 8. Hughes SL, Weaver FM, Giobbie-Hu
Page 124 and 125: 8 COMPLEMENTARY AND ALTERNATIVE (UN
Page 126 and 127: corresponding benefit in obstructiv
Page 128 and 129: 3. Eisenberg DM, Kessler RC, Van Ro
Page 130 and 131: areas of the state were more likely
Page 132 and 133: 8 Miller DC, Litwin MS, Bergman J,
Page 134 and 135: 10 EMERGING THERAPIES It is impossi
Page 136 and 137: APPENDIX 1 GUIDELINE DEVELOPMENT PR
Page 138 and 139: study type. Studies published befor
Page 140 and 141: Grade of recommendation Description
Page 142 and 143: 2. National Health and Research Cou
Page 144 and 145: Dr Carole Pinnock AM Principal rese
Page 146 and 147: Surgery Professor Villis Marshall A
Page 148 and 149: APPENDIX 3 TNM CLASSIFICATION OF PR
Page 150 and 151: Summary Prostate T1 T2 T3 T4 N1 M1a
Page 152 and 153: APPENDIX 4 ABBREVIATIONS AND GLOSSA
Page 154 and 155: Glossary Actuarial survival A metho
Page 156 and 157: Effectiveness The extent to which a
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Lymph nodes Small, generally pea-si
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Each stage is divided into subgroup
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APPENDIX 6 - ORGANISATIONS WHICH PR
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Consultant Urologist, Royal Brisban
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No conflict of interest to declare.
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Index to Clinical practice guidelin
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cardiovascular mortality 19, 54, 55
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androgen deprivation therapy (ADT)
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and surgery 32-34 survival 18 toxic
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and chemotherapy 89-90 see also bon
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spinal cord compression 62-63 see a
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systemic 141 Tasmania Association f
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