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

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olus) in addition to radiotherapy ambulant at six months compared with 33% of those treated with radiotherapy alone (p=0.05). The addition of dexamethasone significantly (p=0.046) improved the probability of surviving with gait function in the year following treatment without a significant increase in serious toxicities. The Vecht trial comparing high and low doses of dexamethasone showed no difference in pain, ambulation rates or bladder function between the two arms but the low power of the study (37 patients) cannot exclude clinically important differences. Evidence summary Level References There is one small trial of high-dose dexamethasone and radiotherapy versus radiotherapy alone. This demonstrated a significant improvement in ambulation rates in the steroid arm. The optimal dose of steroids is unknown, with one small trial demonstrating no significant difference in efficacy of higher-dose dexamethasone over lower doses. Recommendations II 85 II 87 Patients being treated with radiotherapy for malignant spinal cord compression should also receive dexamethasone. Grade C The optimal dose of dexamethasone remains to be defined. Grade D 5.2.2 Hemibody (widefield) external beam radiotherapy Hemibody radiotherapy refers to the practice of irradiation of either the lower body half (pelvis and legs) or the upper body half (upper lumbar spine, chest, arms with or without the skull). It was a commonly used treatment for prostate cancer with multifocal pain when effective chemotherapy or radionucleide therapy was not available. There are no controlled trials comparing pain responses with and without hemibody radiotherapy. One low-quality RCT (Poulter 1992, n=499, 33% prostate cancer patients 88 ) examined whether hemibody radiation in addition to local radiation retarded disease progression for patients with moderately to severely painful single or multiple bone metastases. The addition of hemibody radiation (8Gy, single fraction) to local radiotherapy significantly retarded disease progression as evidenced by increase in lesion size (p=0.03) and number (p=0.01). However, in this study 88 , hemibody radiation was associated with a significant increase in grades 3 and 4 haematological toxicity (p=0.004), with leukopenia being significantly worse (p=0.01). A quasi-randomised controlled trial by Scarantino (n=144, 70% prostate cancer) 89 examined the effects of increasing the dose of hemibody irradiation in conjunction with local radiotherapy on progression and toxicity. This study was unable to show that increasing multi-fraction hemibody radiation dose from 10Gy to 20Gy significantly reduced the development of new metastases when given in conjunction with local radiotherapy. 65 Overt metastatic disease and/or loco-regional progressive disease
A second low-quality RCT by Salazar 2001 (n=156, 32% prostate cancer) 90 examined escalating doses of hemibody radiotherapy without local radiotherapy. When given alone, increasing hemibody radiation dose as multi-fraction regimens from 8Gy to 15Gy 90 did not significantly improve overall pain responses (response rates 89% and 92%). However, it did significantly (p=0.016) improve complete pain responses without an apparent increase in grade 3–4 toxicity (16% at 8Gy and 8% at 15Gy). Evidence summary Level References There are no controlled trials comparing pain responses with and without hemibody radiotherapy. Increasing hemibody radiation doses above 8Gy does not improve overall pain palliation. There is no good evidence to support the use of fractionated hemibody irradiation over a single fraction. Adding hemibody radiation to local external beam radiotherapy while retarding progression increases grade 3–4 haematological toxicity. 5.3 Bisphosphonates II 88,90 III-1 89 No recommendations have been made for hormone naïve metastatic disease. See section 6.3.1 Bisphosphonates and the prevention of skeletal-related event for a discussion of a single trial of bisphosphonates for hormone-naïve metastatic bone disease. 5.4 Chemotherapy See chapter 10 Emerging therapies, p116. (10.4) Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 66
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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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Page 36 and 37: different treatments from different
Page 38 and 39: Evidence summary Level References I
Page 40 and 41: Evidence summary Level References F
Page 42 and 43: Despite these reservations and the
Page 44 and 45: For non-metastatic disease there we
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Page 48 and 49: monotherapy for low-to-intermediate
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Page 52 and 53: for surgery, suggesting that surger
Page 54 and 55: Microscopic fully resected node pos
Page 56 and 57: 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 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 108 and 109: hydrocortisone respectively. Tannoc
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
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Page 132 and 133: 8 Miller DC, Litwin MS, Bergman J,
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10 EMERGING THERAPIES It is impossi
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APPENDIX 1 GUIDELINE DEVELOPMENT PR
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study type. Studies published befor
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Grade of recommendation Description
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2. National Health and Research Cou
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Dr Carole Pinnock AM Principal rese
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Surgery Professor Villis Marshall A
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APPENDIX 3 TNM CLASSIFICATION OF PR
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Summary Prostate T1 T2 T3 T4 N1 M1a
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APPENDIX 4 ABBREVIATIONS AND GLOSSA
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Glossary Actuarial survival A metho
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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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