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

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Evidence summary Level References There is no evidence to support the routine use of extended field radiotherapy for locally advanced prostate cancer. The role of whole pelvis radiotherapy has yet to be defined. There is some evidence to support the increased efficacy for doseescalated external beam radiotherapy for biochemical and clinical relapse. These data have not yet translated into improved survival or a reduction in distant disease-free survival. There is some evidence that dose-escalation increases toxicity, however, the impact on quality of life is yet to be determined. It is uncertain whether any benefits of dose escalation can be generalised to patients receiving neoadjuvant and/or adjuvant endocrine therapy. There is evidence that conformal radiotherapy decreases toxicity compared with conventional radiotherapy Recommendation II 62-64, 66, 71-76, 78-82 When radiation therapy alone is used, limited field radiotherapy has similar efficacy and has less toxicity than whole pelvis and therefore is recommended. The role of whole pelvis radiation is yet to be defined. Consideration should be given to dose escalation (74Gy or higher) if it can be delivered safely. Patients with locally advanced prostate cancer should receive 3D conformal radiation to minimise toxicity. Grade C External beam radiotherapy compared with other treatments for local control The management of locally advanced prostate cancer has long been controversial. For patients with a reasonable life expectancy, radiotherapy has traditionally been utilised. More recently, hormonal therapy combined with radiotherapy has been shown to improve outcomes. ADT alone has traditionally been used for locally advanced disease in patients with a poor performance status and/or significant co-morbidities predicting a short life expectancy. Locally uncontrolled disease can be a morbid situation for patients, however, and may cause symptoms related to obstruction, renal impairment, bleeding and pain. Prior to 2006 (the cut-off date for inclusion of trials for this analysis), there were only three randomised trials comparing radiotherapy with alternative treatment approaches for locally advanced prostate cancer. These all asked different questions, contained small numbers of patients (between 73 and 151 patients), used old techniques, and provided conflicting results. There was a suggestion of improved survival of radiotherapy over orchidectomy in one study of 151 patients 8, 9 , but at a cost of increased toxicity. Another study of 73 patients 83 suggested that radiotherapy compared with observation did not delay the first onset of metastases but no long-term follow-up with survival was given. A third study of 95 patients 84 suggested an improvement in progression-free survival with surgery and hormones versus low-dose radiotherapy plus hormones, but at the cost of increased toxicity in the surgery group. Long-term follow-up of the Akakura study published since 2006 85 has demonstrated similar results with a non-significant trend for improved disease-free survival but at increased toxicity. 27 Locally advanced disease
Evidence summary Level References There are only three randomised trials comparing radiotherapy with alternative treatment approaches for locally advanced prostate cancer. These all asked different questions, contained small numbers of patients, used old techniques, and provided conflicting results. The current body of evidence does not exclude a clinically important benefit with the use of radiotherapy in locally advanced prostate cancer. Recommendation II and III-1 8, 9, 83, 84, 86 Based on randomised trial evidence, it is not possible to quantify the degree of benefit provided by radiotherapy alone for locally advanced prostate cancer. The role of surgery or hormonal therapy alone in this group of patients remains to be defined. Grade D Based on randomised trial evidence, it is not possible to quantify the degree of benefit provided by radiotherapy alone for locally advanced prostate cancer and that the role of surgery or hormonal therapy alone in this group of patients remains to be defined. However, as detailed in the following section on the role of brachytherapy, the totality of data supports the use of androgen deprivation and radiotherapy over radiotherapy alone. The degree of benefit of adding radiotherapy to androgen deprivation was uncertain until a landmark Scandinavian trial was published in The Lancet in January 2009. 87 This randomised 875 men with high-risk prostate cancer to hormonal therapy alone (three months of combined androgen blockade followed by indefinite flutamide) or to the same hormonal therapy combined with radiation (3D conformal radiotherapy to prostate and seminal vesicles to dose of 70Gy). Of the cohort 78% had T3 disease and 40% had a PSA>20. With a median follow-up of 7.6 years, there was a 10% improvement in overall survival with the radiotherapy arm (70.4% versus 60.6%). Prostate-specific mortality (for T3 and PSA>20 subgroups as well as the entire cohort) and biochemical control were also improved with the addition of radiotherapy but at the cost of slightly higher rates of urinary, bowel and sexual problems at five years. Recommendation Radiation in addition to hormone therapy improves survival and is recommended. Grade B The role of brachytherapy Brachytherapy involves the implantation or insertion of small ‘sealed sources’ containing a radioactive isotope into the prostate gland either temporarily or permanently. This allows high doses of radiation to be delivered to the prostate gland while minimising doses to adjacent structures such as the rectum and bladder. There are two main types of brachytherapy commonly used for prostate cancer in Australia: Permanent implant brachytherapy. This involves the permanent implantation of multiple radioactive seeds (generally Iodine-125 in Australia) directly into the prostate. Seeds are placed through the perineum under ultrasound guidance. In the great majority of cases, low-dose brachytherapy is used as Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 28
Page 1: Clinical Practice Guidelines for th
Page 4 and 5: 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 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 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
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
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the median overall survival for pat
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There are two points regarding bisp
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with bone pain at study entry. At n
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Recently, there have been reports o
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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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