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Centre for Reviews and Dissemination Parenteral Oestrogens for Prostate Centre for Reviews and Dissemination A Systematic Review of Parenteral Oestrogens for Prostate Cancer Parenteral Oestrogens for Prostate Cancer: A Systematic Review of Clinical Effectiveness and Dose Response 33 Promoting the use of research based knowledge REPORT 33 CRD Parenteral oestrogens for prostate cancer: A systematic review of clinical effectiveness and dose response Michael Emmans Dean2 Gill Norman1 Zoé Hodges6 Gill Ritchie3 Kate Light1 Alison Eastwood1 Ruth Langley4 Matthew Sydes4 Mahesh Parmar4 Paul Abel5 1 Centre for Reviews and Dissemination, University of York, York YO10 5DD 2 Department of Health Sciences, University of York, York YO10 5DD 3National Collaborating Centre for Primary Care, Frazer House, 32-38 Leman Street, London, E1 8EW 4MRC Clinical Trials Unit, 222 Euston Road, London 5Imperial College, London, W12 0NN 6 Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, WC1B 3RE September 2006 © 2006 Centre for Reviews and Dissemination, University of York ISBN 1 900640 37 6 This report can be ordered from: Publications Office, Centre for Reviews and Dissemination, University of York, York YO10 5DD. Telephone 01904 321458; Facsimile: 01904 321035: email: [email protected] Price £12.50 The Centre for Reviews and Dissemination is funded by the NHS Executive and the Health Departments of Wales and Northern Ireland. The views expressed in this publication are those of the authors and not necessarily those of the NHS Executive or the Health Departments of Wales or Northern Ireland. Printed by York Publishing Services Ltd. ii CENTRE FOR REVIEWS AND DISSEMINATION The Centre for Reviews and Dissemination (CRD) is a facility commissioned by the NHS Research and Development Division. Its aim is to identify and review the results of good quality health research and to disseminate actively the findings to key decision makers in the NHS and to consumers of health care services. In this way health care professionals and managers can ensure their practice reflects the best available research evidence. The reviews will cover: the effectiveness of care for particular conditions; the effectiveness of health technologies; and evidence on efficient methods of organising and delivering particular types of health care. Further Information General Enquiries: 01904 321040 Information Service 01904 321078 Publications: 01904 321458 Fax: 01904 321041 Email: [email protected] CRD Reports 1. Which way forward for the care of critically ill children? (1995) £7.50 2. Relationship between volume & quality of health care (1995) £5.00 4. Undertaking systematic reviews of research on effectiveness. 2nd edition (2001) £12.50 5. Ethnicity and health (1996) £12.50 6. Improving access to cost-effectiveness information for health care decision making: the NHS Economic Evaluation Database. (2nd Edition 2001) £9.50 7. A pilot study of ‘Informed Choice’ leaflets on positions in labour (1996) £7.50 8. Concentration and choice in the provision of hospital services (1997) Summary Report £6.00 Part I - Hospital volume and quality of health outcomes £12.50 Part II - Volume and the scope of activity and hospital costs £9.50 Part III - Concentration, patient accessibility and utilisation of service £7.50 Complete set of reports £30.00 9. Preschool vision screening: results of a systematic review (1997) £9.50 10. Systematic review of interventions in the treatment and preventionof obesity (1997) £12.50 11. A systematic review of the effectiveness of interventions for managing childhood nocturnal enuresis (1997) £12.50 13. Screening for ovarian cancer: a systematic review (1998) £12.50 14. Women and secure psychiatric services: a literature review (1999) £12.50 15. Systematic review of the international literature on the epidemiology of mentally disordered offenders (1999) £12.50 16. Scoping review of literature on the health and care of mentally disordered offenders (1999) £12.50 17. Therapeutic community effectiveness: community treatment for people with personality disorders and mentally disordered offenders (1999) £12.50 18. A systematic review of water fluoridation (2000) £20.00 19. The longevity of dental restorations: a systematic review (2001) £20.00 20. Informed choice in maternity care: an evaluation of evidence based leaflets (2001) £20.00 21. Scoping review of the effectiveness of mental health services (2001) £12.50 22. The effectiveness of interventions used in the treatment/management of chronic fatigue syndrome and/or myalgic encephalomyelitis in adults and children (2002) £12.50 23. Access to the online evidence base. A survey of the Northern and Yorkshire Region (2003) £7.50 24. Outcomes measurement in psychiatry (2003) £12.50 25. Scoping review of sabotage and/or tampering in the NHS (2004) £12.50 26. Predictors of delay in seeking medical help in patients with suspected heart attack, and interventions to reduce delay: A systematic review (2004) £12.50 27. A systematic review of cancer waiting time audits (2005) £12.50 28. Systematic review of the clinical and cost effectiveness of ultrasound in screening for developmental dysplasia of the hip in newborns (2005) £12.50 29. Diagnostic value of systematic prostate biopsy methods in the investigation for prostate cancer: a systematic review (2005) £12.50 30. The effects of psychosocial interventions in cancer and heart disease: A review of systematic reviews (2005) £12.50 31. Systematic review of barriers, modifiers and benefits involved in participation in cancer clinical trials (2006) £12.50 32. Systematic review of interventions to increase participation of cancer patients in randomised controlled trials (2006) £12.50 iii Table of Contents Executive Summary…………………………………………………………………………………... v 1. Introduction…………………………………………………………………………………………. 1 2. Review Questions…………………………………………………………………………………... 3 3. Methods……………………………………………………………………………………………... 4 4. Results………………………………………………………………………………………………. 8 5. Discussion…………………………………………………………………………………………... 31 6. Conclusions…………………………………………………………………………………………. 34 References……………………………………………………………………………………………… 35 Appendix 1: Search Strategies……………………………………………………………………….. 38 Appendix 2: Data Extraction Form…………………………………………………………………… 58 Appendix 3: Quality Assessment Proforma…………………………………………………………. 59 Appendix 4: List of Abbreviations……………………………………………………………………. 60 Appendix 5: Stages and Grades……………………………………………………………………... 61 Appendix 6: List of Excluded Studies… …………………………………………………………… 63 Appendix 7: Data Extraction Tables……………… ……………………………………………… 66 List of Tables Table 1: Interventions and comparators……………………………………………………………. 9 Table 2: Summary of studies using parenteral oestrogen and reporting survival data………... 17 Table 3: Summary of studies using parenteral oestrogen in combination and reporting survival data………………………………………………………………………………… 20 Table 4: Cardiovascular events and deaths reported in studies employing parenteral oestrogen……………………………………………………………………………………. 23 Table 5: Cardiovascular events and deaths reported in studies employing parenteral oestrogen in combination………………………………………………………………….. 26 Table 6: Summary of studies using parenteral oestrogen and reporting testosterone data….. 28 Table 7: Summary of study using parenteral oestrogen in combination and reporting testosterone data…………………………………………………………………………… 30 List of Figures Figure 1: Summary of study identification, retrieval and inclusion/exclusion…………………… 8/9 Figure 2: Overall mortality in trials employing parenteral oestrogen alone in which data 18 were fully reported………………………………………………………………………… Figure 3: Prostate cancer mortality in trials employing parenteral oestrogen alone in which 18 data were fully reported…………………………………………………………………… Figure 4: Overall survival in trials using parenteral oestrogens in combination with oral 21 oestrogens in which data were fully reported…………………………………………… Figure 5: Cancer mortality in trials using parenteral oestrogens in combination with oral 21 oestrogens for which data could reliably be extracted…………………………………. Figure 6: Cardiovascular mortality in trials involving parenteral oestrogen alone 24 for which data were fully reported………………………………………………………... Figure 7: Cardiovascular morbidity in trials involving parenteral oestrogen alone 24 for which data were fully reported ………………………………………………………. Figure 8: Cardiovascular mortality in trials using parenteral oestrogens in combination with 27 oral oestrogens in which data were fully reported……………………………………... Figure 9: Cardiovascular morbidity in trials using parenteral oestrogens in combination with 27 oral oestrogens in which data were fully reported……………………………………... iv Executive Summary Objectives This review was undertaken to inform the design of a clinical trial using transdermal oestrogen patches in prostate cancer. The main objectives were: 1. To examine the clinical effectiveness and safety of parenteral oestrogen therapy in prostate cancer. 2. To examine the relationship between dose and efficacy and safety of parenteral oestrogen in prostate cancer. 3. To compare the safety profile of oestrogen given transdermally with other routes of administration, in males or male-to-female transsexuals with any condition. Methods Search strategy Eighteen electronic databases including EMBASE and MEDLINE were searched from inception to March 2004. Appropriate paper and internet resources were also searched. Inclusion/exclusion criteria Objective 1: Randomised controlled trials of parenteral oestrogen compared with any treatment in patients diagnosed
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