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

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All three trials demonstrated improved biochemical progression-free survival in patients receiving adjuvant radiotherapy (EORTC: hazard ratio=0.48, 98% CI=0.37to0.62, p
3.2.2 Adjuvant systemic chemotherapy See chapter 10 Emerging therapies, p116 3.2.3 Adjuvant androgen deprivation therapy See section 3.1.3 Radiotherapy and androgen deprivation therapy, p30. 3.3 Node-positive disease 3.3.1 Radiotherapy and adjuvant androgen deprivation therapy The role of radiotherapy for node-positive disease is controversial. There are three RCTs containing subgroups of node-positive (primarily biopsy proven) patients that evaluate any effect of adjuvant androgen deprivation when combined with radiotherapy. Two RCTs examined radiotherapy with adjuvant ADT versus radiotherapy with ADT as a possible treatment on progression. The first, RTOG 85-31, used LHRH agonist until progression 112 . The second used a non-steroidal anti-androgen for a minimum of two years. 113 The third RCT examined radiotherapy with concurrent plus adjuvant ADT (orchidectomy prior to radiotherapy) versus radiotherapy with ADT on progression. 114 The largest RCT, RTOG 85-31, was of medium quality for survival whereas the two smaller RCTs were of low quality. In all three trials the analyses for node-positive disease were unplanned subgroup analyses, increasing the risk that the arms may not be balanced for potential risk factors in this subgroup of patients. The largest subgroup with 173 participants was from RTOG 85-31. The Granfors study contained a subgroup of 39 node-positive patients and the Iversen study contained only 14 patients in their node-positive subgroup. 113 Radiotherapy doses were either not described or varied in all studies. The RTOG 85-31 and Granfors studies provided data for survival, prostate cancer survival and disease progression. The RTOG 85-31 study showed a trend towards improved survival with 6.5 years median follow-up. A multivariate analysis of patients for whom Gleason scores were available and which took into account Gleason score and whether the men had undergone radical prostatectomy found a statistically significant improvement with adjuvant ADT, with a nine-year survival rate of 62% for adjuvant ADT versus 38% for radiotherapy alone. The smaller Granfors trial with a median follow-up of 9.3 years showed a statistically significant survival benefit for immediate orchidectomy with a nine-year survival rate of 50% for immediate orchidectomy therapy versus 13% for radiotherapy alone. 114 Similar results were found for prostate cancer mortality. With longer follow-up to 19 years, this survival benefit was maintained. 115 The Iversen study had reduced rates of clinical or biochemical progression with anti-androgen therapy in their very small subgroup of men. 113 Isolated biopsy proven node-positive disease represents a relatively small cohort of prostate cancer patients. In these patients there is potential for a major survival benefit with androgen deprivation in addition to radiotherapy. However it is not known whether adding radiotherapy to androgen deprivation for node-positive patients provides any benefit. Only one of the three RCTs, RTOG 85-31, examined radiotherapy toxicity outcomes for adjuvant ADT–in this trial LHRH agonist therapy–for the node-positive patient subgroup. The authors reported that the incidence of grade 3 and 4 acute and late toxicities was not statistically significantly different. As long-term adjuvant androgen deprivation as an adjuvant to radiotherapy appears to improve the survival of men with biopsy node-positive prostate cancer, no evidence of increased radiotherapeutic toxicities would have a substantial clinical impact. However, the hormone-associated toxicities that would have an impact on quality of life were not assessed, reducing the clinical impact. One trial reports no difference in grade 3 and 4 toxicities with LHRH agonist treatment after radiotherapy. Other known toxicities of hormonal therapy were not reported. 112 Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 38
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Clinical Practice Guidelines for th
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4 Biochemical relapse .............
Page 6 and 7: FOREWORD The management of prostate
Page 8 and 9: SUMMARY OF CLINICAL PRACTICE RECOMM
Page 10 and 11: SUMMARY OF RECOMMENDATIONS Chapter
Page 12 and 13: Chapter Recommendations Grade Refs
Page 20 and 21: 1 INTRODUCTION 1.1 Natural history
Page 22 and 23: 2 PSYCHOSOCIAL CARE The diagnosis a
Page 24 and 25: 2.2 Effect of psychological and cog
Page 26 and 27: Evidence summary Level References T
Page 28 and 29: Recommendation Men with advanced pr
Page 30 and 31: An Australian cross-sectional study
Page 32 and 33: 10. Dunn J, et al. A review of peer
Page 34 and 35: 41. Sharpley CF, Christie DRH. An a
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
Page 46 and 47: Evidence summary Level References T
Page 48 and 49: monotherapy for low-to-intermediate
Page 50 and 51: Evidence summary Level References M
Page 52 and 53: for surgery, suggesting that surger
Page 54 and 55: Microscopic fully resected node pos
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
Page 70 and 71: Evidence summary Level References F
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
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Side effects (toxicity) As these ra
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hydrocortisone respectively. Tannoc
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5. Manikandan R, Srirangam SJ, Pear
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33. Elomaa I, Kylmala T, Tammela T
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60. Janknegt RA, Abbou CC, Bartolet
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physiotherapists, occupational ther
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7.5 Q2: Symptom control There was e
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Informal or family caregivers deriv
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8. Hughes SL, Weaver FM, Giobbie-Hu
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8 COMPLEMENTARY AND ALTERNATIVE (UN
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corresponding benefit in obstructiv
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3. Eisenberg DM, Kessler RC, Van Ro
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areas of the state were more likely
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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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