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

More documents

Recommendations

Info

Evidence summary Level References For men without clinical evidence of metastatic disease, four trials showed no increase in cardiovascular mortality or myocardial infarction with orchidectomy or long-term LHRH agonist treatment. However, larger population-based studies are required to reveal the small impact. Castration was associated with hot flushes and breast changes (one trial) and cognitive decline (one trial). Anti-androgens were associated with a significantly increased likelihood of heart failure (bicalutamide), increased impotence, hot flushes, gynaecomastia and breast pain, nausea and vomiting, tiredness and asthenia. When compared with castration, bicalutamide resulted in smaller increases in body fat mass, fewer hot flushes and a lower incidence of decreased libido, but an increased incidence of breast changes. Unlike castration, bicalutamide did not decrease bone density at 12 and 96 months. Three trials showed no significant increase in cardiovascular mortality with short-term CAB. II 1, 3, 18-21 6, 22,23 11,24,25 26-28 30, 34 It should first be clarified that the recommendations are made with the observation that with the exception of adjuvant therapy with radiation therapy for high-risk and intermediate-risk prostate cancer and lymph node positive fully resected disease, there is no known survival advantage in commencing ADT early (as indicated by increasing serum PSA levels alone after definitive local therapy) rather than later (with radiographically evident metastases). This is particularly important as there is a significant number of unwanted effects (understated in this review) that have a significant impact on quality of life. Therefore, that which is important to the patient should be considered together with his co-morbidities. Specifically, the early commencement of ADT with castration (either as monotherapy or with an anti-androgen) may be more undesirable for individuals for whom sexual activity is very important and for those struggling to cope with declining cognitive abilities or with baseline osteopaenia. 21 Locally advanced disease
Recommendation It is recommended that the prescriber take into account the following points when commencing ADT: The use of non-steroidal anti-androgens as monotherapy may have fewer and less severe adverse events than medical or surgical castration but may still have a toxicity profile that impairs quality of life, and there is little to no efficacy data to support their use as monotherapy. Extrapolating from evidence with metastatic disease (see chapter 5 Overt metastatic disease and/or loco-regional progressive disease), Combined androgen blockade (CAB) with an antiandrogen does increase the adverse event profile versus medical or surgical castration monotherapy and this needs to be weighed up against its marginal additional survival benefits seen in patients with metastatic disease. When the unwanted effects of treatment are preferable to the unwanted effects of the tumour (e.g. prevent recurrence with increased overall survival in adjuvant setting), the side-effect profiles of the treatment options should be explained and strategies to minimise these effects should be considered with the patient. Grade B Effects on bone health and the risk of fractures There are numerous studies reporting the effects of medical or surgical castration on bone mineral density (BMD) and fracture rates in men with prostate cancer. Most were observational with results from both prospective and retrospective analyses of hospital and collated organisational data. There were two randomised studies 24;25 comparing changes in BMD in patients randomised to bicalutamide or LHRH agonists. Many studies had industry support, including the two randomised studies that were supported by AstraZeneca. Measurement methods: Two methods were used to measure BMD changes with Dual Energy X-ray Absorptiometry (DEXA) was the more commonly employed method. However DEXA is not ideal for measuring changes in lumbar spine BMD in older individuals as it does not distinguish aortic calcification and sclerosis of spinal discs and joints known to increase with age. 35 There were fewer manuscripts reporting use of the more sensitive barometer of quantitative computerised tomography (QCT) which, however, exposes patients to more radiation and is subject to quality control issues. This review focuses on changes in femoral BMD as measured by DEXA and lumbar BMD as measured by QCT. There were a number of other limitations arising out of study designs and the modes of reporting outcomes. The criteria used for reporting changes in BMD varied, reflecting a lack of accepted and standardised or validated yardsticks for men compared with those agreed and accepted for women. Most studies reported the change in mean BMD rather than the incidence of clinically significant decrease in bone mineral density or osteoporosis. Few studies attempted to distinguish osteoporotic fractures from metastatic and traumatic fractures, and the definition of osteoporotic fractures varied. Finally, in comparative studies there were usually baseline differences between the groups that have the potential to confound the results. This was so even when comparing prostate cancer patients with and without ADTs, as ADT may be associated with more aggressive disease or more advanced disease stage. In many studies, disease stage was unclear. Clinical practice guidelines for the management of locally advanced and metastatic prostate cancer 22
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 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 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
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
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
Page 158 and 159:
Lymph nodes Small, generally pea-si
Page 160 and 161:
Each stage is divided into subgroup
Page 162 and 163:
APPENDIX 6 - ORGANISATIONS WHICH PR
Page 164 and 165:
Consultant Urologist, Royal Brisban
Page 166 and 167:
No conflict of interest to declare.
Page 168 and 169:
Index to Clinical practice guidelin
Page 170 and 171:
cardiovascular mortality 19, 54, 55
Page 172 and 173:
androgen deprivation therapy (ADT)
Page 174 and 175:
and surgery 32-34 survival 18 toxic
Page 176 and 177:
and chemotherapy 89-90 see also bon
Page 178 and 179:
spinal cord compression 62-63 see a
Page 180 and 181:
systemic 141 Tasmania Association f
show all

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

Create successful ePaper yourself

Delete template?

Save as template?